Great Debates and Updates in Diabetic Foot 2024 Abstracts
001: The Woes of Hallux Trauma Correction in the Neuropathic Uncontrolled Diabetic
Submitter/Primary Author: Boyd Bills, DPM
Introduction: I present 3 unique cases of hallux trauma involving the interphalangeal joint. What links the patients together is their similar underlying conditions. All 3 patients have diabetic neuropathy secondary to uncontrolled diabetes mellitus. Outcomes were the same for all the patient of septic arthritis and joint destruction of the interphalangeal joint. All were treated with surgical intervention and antibiotic therapy, but in the end the hallux was stabilized and amputation was prevented.
Methods: Case #1: The patient presented with hallux trauma to the great toe with a capsular injury of the first metatarsophalangeal joint causing hallux varus. The IPJ was then exposed from shoe trauma. First metatarsophalangeal joint fusion was performed with IPJ arthroplasty. Infection ensued. Antibiotic treatments were performed. The infection resolved, but not without distraction to the IPJ.
Case #2: The patient presented following IPJ fusion. The patient 1 week postop jammed his toe and fractured the distal phalanx. The hardware came loose. The hardware is removed and a revision fusion of the IPJ was then performed. Septic arthritis, hardware infection with MRSA followed. The patient was admitted resection was performed. Antibiotics were administered. Incision healed and the patient has a functional, shortened hallux.
Case #3: Open distal phalanx fracture also and countering the IPJ. ORIF followed. Four weeks following surgery, the patient reported with septic arthritis of the first metatarsophalangeal joint. The patient was admitted and IV antibiotics were administered. The infection resolved.
Results: In all 3 patients an amputation was prevented.
Discussion: It is apparent that these open types of injuries require a longer term antibiotic therapy with higher risk of septic arthritis and osteomyelitis. Though this is a small sample size with varying types of trauma, the underlying disease systems increase the risk of infection, but amputation can be prevented with appropriate care.
002: Use of a Novel Negative Pressure Peel and Place Dressing in Four Patients with Diabetic Foot Ulcers or Diabetic Foot Amputation Wounds
Submitter and Primary Author: Robert Klein, DPM, FACFAS, CWS
Introduction: Negative pressure wound therapy (NPWT) typically requires dressing changes every 2 to 3 days. A novel dressing has been developed that incorporates a fenestrated, non-adherent layer and negative pressure drape into the dressing design allowing for up to seven days of wear. Use of this peel and place dressing* in 4 patients with diabetic foot ulcers or diabetic foot amputation wounds is presented.
Methods: Systemic antibiotics were given as necessary. Patients underwent sharp debridement prior to application of the peel and place dressing if needed. Dressing changes occurred every 4 to 7 days. Upon dressing removal, all wounds were cleansed using a hypochlorous acid solution and gently patted dry.
Results: Four patients (age range 66–75 years) presented for care. Wound types included Wagner Grade 3 diabetic foot ulcers (n=2), surgical dehiscence following transmetatarsal amputation (n=1), and surgical wound after open first ray amputation (n=1). Patient comorbidities included diabetes, neuropathy, coronary heart disease, hypertension, tobacco use, and obesity. Prior treatment included traditional NPWT or use of medical honey. Prior to presentation, wounds were present from 12 to 116 days. Dressing applications were simple, taking approximately 2 minutes to complete. None of the patients reported any pain at dressing application or dressing change. Granulation tissue development and wound size reduction was noted in all patients. Mild periwound maceration was observed in 2 patients, with 1 due to non-compliance with offloading and diaphoresis. Mild skin irritation was observed in 1 patient that was resolved once the dressing size was reduced.
Discussion: Use of NPWT with the novel peel and place dressing for wound management resulted in increased granulation tissue development and wound size reduction in all patients. The dressing design simplified application resulting in less time needed for dressing changes. Patients did not report any pain during dressing application or removal.
Trademarked Items: *3M™ V.A.C.® Peel and Place Dressing with 3M™ ActiV.A.C.™ Therapy System, Solventum Corporation, Maplewood, MN
003: Initial Experience with a Novel Negative Pressure Wound Therapy Peel and Place Dressing in Lower Extremity Wounds
Submitter/Primary Author: Ralph J. Napolitano, Jr., DPM, CWSP, FACFAS
Introduction: The application of negative pressure wound therapy to support healing of lower extremity wounds is well-documented.1 A recently available multilayer peel and place dressing (MPPD)* incorporates a perforated non-adherent layer, reticulated open cell foam dressing, and a hybrid acrylic and silicone drape, which enable it to be placed over the wound and surrounding intact skin. In this case series, we report the outcomes of application of NPWT with MPPD in 4 patients with lower extremity wounds.
Methods: Deidentified data was collected after obtaining informed patient consent and stored in accordance with federal regulations. Patients had injuries to the foot or lower leg and received NPWT with MPPD at -125 mmHg for 10–21 days, with dressing changes conducted every 5–7 days.
Results: Two male and 2 female patients, ages 28 to 77 years old, were included in the study. Wound etiologies included surgical wounds, a traumatic injury, and a decubitus ulcer. After 10 days of therapy, the wounds showed notable improvement and there was a significant reduction of periwound edema. We observed no periwound maceration in 3 patients; in the fourth, maceration was noted at the first dressing change and resolved after negative pressure was increased to 150 mmHg.
Discussion: The new NPWT dressing performed as expected, removing exudate and creating an environment conducive to wound healing. Application of the MPPD dressing was quick and easy, requiring only minimal trimming or shaping of the drape.
Trademarked Items: *3M™ V.A.C.® Peel and Place Dressing; Solventum, Maplewood, MN
Reference
1. Capobianco CM, Zgonis T. An overview of negative pressure wound therapy for the lower extremity. Clin Podiatry Med Surg. 2009;26(4):619-631. doi:10.1016/j.cpm.2009.08.002
004: Diabetic Foot Salvaged, Wounds Closed in Only Two Months Using Polymeric Membrane Dressings
Submitter/Primary Author(s): Linda Benskin, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA, WOCNF
Introduction: An elderly woman with previously undiagnosed Type 2 diabetes came to the clinic with massive right foot abscesses of over 3 months’ duration. The dorsum had a small pus-filled open area, the great and small toes were oozing pus and the skin on both the dorsal and plantar surfaces of the foot was stretched tight. The great toe had self-amputated at the first interphalangeal joint. The area filled with malodorous thick yellow exudate extended between the plantar skin and muscle from the bases of the toes to the middle of the major arch and wrapped around the lateral edge of the foot. Pain in the deeper tissues of her foot prevented weight-bearing, but the patient was unaware of the extent of her infection. She had wrapped the foot in cloth but had not otherwise treated the wounds.
Methods: Following the extensive sharp debridement, polymeric membrane cavity filler was inserted into the cavernous sole wounds, the lateral edge of the foot and through a tunnel at the great toe. All exposed polymeric membrane cavity filler was then covered with standard polymeric membrane dressings. Dressing changes were daily for the first few weeks.
Results: Blood and bits of slough adhered to the dressing surfaces, but the wound beds were consistently clean, so no manual cleansing was done. Granulation tissue quickly filled in the now-clean cavities created by the initial removal of copious malodorous exudate and dead bones. When the sole cavity was completely filled in, the area was permitted to seal shut. The cavity along the proximal edge of the foot filled in more gradually; polymeric membrane cavity filler was used in this area almost to complete closure. The woman walked with a cane throughout the treatment. Using only polymeric membrane cavity filler and polymeric membrane dressings, all of the wounds closed within 8 weeks. The woman’s foot mobility was restored.
Discussion: The components of polymeric membrane dressings work together to continuously loosen slough, which is then pulled into the dressings. Usually no manual wound cleansing is needed at dressing changes, so cooling and disruption of fragile newly formed tissue is minimized. This promotes rapid wound closure.
005: Trial of the Available Technology Dressing for Resource Limited Settings
Submitter/Primary Author: Linda Benskin PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA, WOCNF
Co-Author(s): Richard Benskin
Introduction: Clinicians need a safe, effective, affordable, available, acceptable, easy-to-use dressing solution to teach wound self-care patients where funding, sanitation, and climate control is lacking. Our quest to provide an evidence-based solution for wound management in the most challenging environments led to published literature reviews in 2013. Improvised dressings used in India, Ghana, Uganda, Japan, Australia, Angola, and the USA on burns, surgical wounds, leg ulcers, and pressure injuries provided context. Using a Wound Healing Foundation small grant. We trialed our idea on sickle cell leg ulcers (SCLUs) in the tropics in 2021. SCLUs are so challenging to close that usual practice world-wide is wet-to-dry gauze or dry gauze over ointment; more sophisticated dressings have not improved outcomes.
Methods: This 3-armed 12-week evaluator-blinded randomized controlled trial compared:
1) A negative control (wet-to-moist dressings; WTMs); superior to usual practice because it promotes moist healing and removal is less traumatic
2) ATDs: cut-to-fit perforated (with slits) food-grade plastic with a periwound moisture barrier; covered with an absorbent
3) A positive control (polymeric membrane dressings; PMDs); the advanced dressings with the strongest evidence for use a tropical setting
All 3 protocols were rigorously defined. The patients conducted their own dressing changes and submitted data weekly via WhatsApp, with monthly clinic visits.
Results: All groups’ mean healing and quality of life scores improved. These scores improved more for ATD than WTM participants. Participants found ATDs easy-to-use and highly acceptable. Complications were limited to mild Pseudomonas infections with WTMs, successfully treated with dilute vinegar (25% WTM vs 0% ATD and 0% PMD). ATD-managed wounds decreased in size more often than WTM (92% vs 50%). ATDs were not dramatically inferior to PMDs, and were significantly less expensive, but were more time-consuming.
Discussion: ATDs are affordable, available, acceptable, easy-to-use, effective, and safe, even in the tropics.
006: Risk Factors for Delayed Foot Wound Healing in Mexican Americans with Type 2 Diabetes: A Scoping Review
Submitter/Primary Author: Delyssa De La Cerda, BS
Co-Author(s): Vivian Etugbo, MS, Roel Reyna, MS, Amanda L. Killeen, DPM
Introduction: Chronic wound mitigation is a major concern for patients diagnosed with Type 2 diabetes mellitus. Mexican Americans have an increased risk for delayed healing due to secondary factors that impact the healing process. There are options to combat this concern such as: management programs, investigating cultural differences, and providing access to primary care for preventative interventions. This scoping review was conducted with the intent to explore these outcomes and identify the gaps in literature that can seal the bridge for diabetes intervention in Mexican Americans.
Methods: Inclusion criteria consisted of Mexican American individuals over the age of 18 who had history of Type 2 diabetes mellitus with delayed wound healing. The selected studies were published within 2004 to 2024 and were open to include data in English and Spanish. Risk factors chosen included HbA1c, household income, maximum years of education, and type of medical insurance.
Results: Three studies were selected that matched our criteria. In each study, 1,568, 144, and 10 patients were selected, and each supports the claim of secondary risk factors in Type 2 diabetes mellitus that led to delayed wound healing. All studies state the need for community involvement in managing wound healing for patients with Type 2 diabetes.
007: A Sequence of Unfortunate Events: COVID 19, Septic Arthritis, and a Diabetic Patient
Submitter/Primary Author: Alexandria Armstrong, DPM
Co-Author: Lee Rogers, DPM
Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is known worldwide. Patients with confirmed COVID-19 show a wide range of nonspecific symptoms, such as fever, cough, fatigue, loss of smell, joint pain, and diarrhea. A septic joint is defined by the presence of purulent discharge or abscess in deep soft tissue or bone. It is considered a surgical emergency with high risk of limb loss. Isolated ankle and foot joint sepsis is rare, and is usually associated with a contiguous ulcer or concomitant infection, a history of injection into the joint, intravenous drug abuse, prosthetic surgery, or immunocompromise.
Methods: A wheelchair-bound 79-year-old male with PMH of type 2 diabetes with neuropathy, ESRD on dialysis, PAD, colostomy, indwelling foley, osteoarthritis, with hx right foot TMA (2023) presented to the ED for complaints of left foot pain. Patient was somnolent and unable to provide complete history, however endorsed pain from below his knee to the top of his ankle. Temperature was 97.5 F, BP 106/56, pulse 78, RR 16, WBC 15.8, creatinine 4.5, SED rate 102, negative blood cultures, positive urine culture for 2 or more gram-negative rods, with a positive COVID PCR test. Patient had no visible open wounds or lesions to the left foot, with slight redness along the lateral aspect of his left fifth MTPJ, however had no pain on palpation. Left foot x-ray showed destructive osseous changes of fifth MTPJ concerning for septic joint, with osteoarthritis noted along metatarsal heads 2–4.
Results: Patient presented to OR the following day, no purulent drainage noted, no malodor noted, but fragmentation along the fifth metatarsal head and portions of the proximal phalanx base were discovered. Bone culture resulted with light growth of Pseudomonas aeruginosa and Staphylococcus caprae. The patient remained COVID positive for another 5 days, while his WBC continued to fluctuate between 11–14. Infectious disease recommended 6 weeks of IV abx with vancomycin and cefepime. No further surgery was planned and the decision was made to allow the patient to heal secondarily along the surgical site.
Discussion: While no other study has examined the relationship between COVID-19 infection and a hyperinflammatory response leading to a previously controlled arthritis in the foot, other studies have shown a potential correlation between COVID-19 and reactive arthritis. For podiatric patients with multiple comorbidities, a concomitant COVID-19 infection may further exacerbate an already stressed immune system, which further puts a patient at risk for more opportunistic infections.
008: Successful Limb Salvage in a Severe Diabetic Foot Infection: A Case Study of Aggressive Surgical Intervention and Grafting Technique
Submitter and Primary Author: Stephanie N. Campbell, DPM, AACFAS,
Co-Authors: Heather V. Tran, DPM, AACFAS, Nikita Gambhir, DPM, Michael Sobolevsky, DPM
Introduction: A 53-year-old male with uncontrolled diabetes (A1c 7.9%), housing insecurity, and food insecurity presents with severe diabetic foot infection with ascending cellulitis, infectious hemorrhagic bullae, multi-compartment abscesses of the foot and anterior leg. It is known that patients with diabetes are at increased risk of both amputations and more surgical interventions than patients without diabetes in the diabetic space. The patient underwent aggressive surgical intervention to avoid below knee amputation.
Methods: Serial debridement and interval amputations were performed of the right foot to eradicate multiple sinus tracts of draining, heavy purulence > 200 cc. The patient was maintained on IV antibiotics. Following infectious containment and forefoot amputation, complete loss of dorsal soft tissue envelope, the decision to proceed with limb salvage was continued with serial grafting and close monitoring. The forefoot amputation site was remodeled surgically, and the soft tissue defect was primed with acellular wound particulate graft. With satisfactory clinical response, surgery #4 an antimicrobial fetal bovine dermal repair scaffold was applied due to the complicated nature of injury, degree of soft tissue compromise extending to bone, and social factors.
Results: The dermal scaffold contributed to expedited wound healing with reduction in wound depth from bone to near complete leveling in 12 days. Following initial hospitalization, surgical intervention, outpatient wound care continued until split thickness skin grafting was performed. The wounds remain closed with skin turgor and tone of above standard integrity and functional limb. The patient remains ambulatory more than 18 months postoperatively.
Discussion: In severe diabetic foot infections, particularly in the setting of sepsis and necrotizing fasciitis, complicated by multi-compartment infection of the foot and leg, health risk factors, and poor socioeconomic factors, aggressive surgical intervention along with the goals of care are needed to expedite treatment as well as patient expectations. The goal line can initially be obscured due to multi-factorial needs to maintain a functional foot. This case demonstrates successful healing of an at-risk limb due to podiatric surgical intervention with infection control, following by soft tissue management and ultimately split-thickness skin grafting.
009: Investing in Limb Preservation: A Case Study of Successful Foot Salvage in a Vasculopathic Patient
Submitter and Primary Author: Stephanie Campbell, DPM
Co-Authors: Nikita Gambhir, DPM; Heather V. Tran, DPM; Craig J. Verdin, DPM
Introduction: Limb salvage and prosthetics play vital roles in restoring function and mobility for patients with severe injuries or metabolic conditions. Limb salvage involves surgical techniques aimed at preserving a limb rather than resorting to amputation, while prosthetics provide artificial devices to replace lost limbs. Key considerations for limb salvage include restoring a functional foot, maintaining patient independence, minimizing hospitalizations, and avoiding bilateral lower limb amputations.
Methods: The patient, already at single-limb status, presented with a necrotic heel ulcer, exposed calcaneus, and necrotic Achilles tendon. After vascular optimization, the risks and benefits of final aggressive measures were discussed, leading to consent for a partial calcanectomy. The procedure utilized a silo-technique with triple antimicrobial bone cement for the residual heel, including curettage of an aneurysmal bone tumor and evacuation of necrotic tissue. Exposed, tunneled structures were covered with collagen wound matrix*, followed by meshed bilayer wound matrix** to support dermal coverage. A modified external fixation device “SALSAstand” for heel offloading was applied.1
Results: Inpatient spot grafting addressed compromised tissue viability due to central bleeding at the bone, using dehydrated flaked fish-skin graft. Throughout the postoperative period, careful management of bleeding risks directed wound care before frame removal. Multiple grafts were applied due to wound size and depth, resulting in gradual healing, with notable improvements in tissue tone and turgor. The wound fully healed over approximately 6 months, initiating rehabilitation and prosthetic gait training through physical therapy. After nearly 2 years of frequent hospitalizations, the patient has regained functional independence.
Discussion: This case study illustrates the successful management of a vasculopathic patient at high risk for below-knee amputation (BKA) after already experiencing one within the past year. Following bypass surgery, aggressive measures were essential to salvage the remaining limb without compromising the vascular graft. Once healed, the patient transitioned to rehabilitation focused on strength and mobility, primarily for prosthetic gait training on the contralateral limb. This case highlights the critical importance of multidisciplinary management in limb salvage, emphasizing meticulous surgical techniques, surgical offloading, comprehensive rehabilitation strategies, and effective resource allocation for successful limb salvage outcomes.
Trademarked Items: *Integra Flowable Wound Matrix, Newark, NJ, USA **Integra Meshed Bilayer Graft, Newark, NJ, USA +Synthecure Rapid Cure Synthetic Calcium Sulfate, Austin Medical Ventures, Memphis, TN, USA
Reference
1. Clark J, Mills JL, Armstrong DG. A method of external fixation to offload and protect the foot following reconstruction in high-risk patients: the SALSAstand. Eplasty. 2009;9:e21. Published 2009 Jun 4.
010: Results of a Clinical Study Utilizing a Novel Contemporary Designed Medical Device for the Prevention and Treatment of Hospital Acquired Tissue Injuries
Submitter/Primary Author: Michael Jay. Marcus, DPM FACFAS
Introduction: Hospital acquired pressure injuries affect approximately 2.5 million individuals every year in United States acute care facilities. These wounds represent an enormous burden on global healthcare from both a patient care and a budgetary perspective. Currently, there is a gap in the landscape of devices available for prevention and treatment of these lesions. There exist many shortcomings that range from inefficient offloading to cumbersome design. The HeelSphere is a newly patented medical device that is cost effective and efficiently provides offloading of the foot and ankle to prevent and treat these injuries.
Methods: An IRB-approved user study was implemented at our community hospital setting. It involved 28 patients. Two different density devices were utilized and randomized assigned within the protocol. Patients were monitored for 72 hours to assess the effectiveness of the device. Our investigator collected various data points, including but not limited to the offloading distance from the malleoli. Observation for any skin change or reaction secondary to the use of the device was documented as well.
Results: Based on the data collected and evaluated by our statistician, the device proved suitable for use for offloading of the foot and ankle. The HeelSphere statistically provided effective heel offloading. In 93% of the patients the device proved to be comfortable. Throughout the study, there were no reported skin conditions or medical device related tissue injuries as a direct result of the utilization of this device. Data collected from HCP indicated that the device was easy to use and provided effective offloading. Slight variation was seen between the 2 densities with reference to surface cracking (BMI relationship).
Discussion: This newly patented device provides efficient offloading and can be effectively used in the treatment and prevention of HAPIs. Based on its global design it allows for motion of the leg. It is strapless, orange in color, easy to apply, compatible with compressors, facilitates easy observation, lightweight, allows for air flow, and has sensor capabilities. Allowing for easier healthcare access to the wounds and allowing patients to turn in their beds without compromising offloading. The device is also vacuum packaged allowing for easier accessibility.
Trademarked Item: HeelSphere™ US Patent design and utility-11,877,960
012: Prevention of Foot Amputation by Minimally Invasive Surgery in a Diabetic Patient with Osteomyelitis and Peripheral Vascular Disease with a History of Previous Amputations
Submitter/Primary Author: Orlexia Thomas, DPM
Co-Authors: Francois Lokenye, DPM, Lady Paula DeJesus, DPM
Introduction: This study aims to demonstrate the efficacy of minimally invasive surgical interventions in preventing foot amputation and promoting wound healing in a patients with diabetes with osteomyelitis and peripheral vascular disease, compounded by a history of ray resection. Effective management of these conditions is crucial to preserve limb integrity, improve outcomes, and achieve wound closure.
Methods: The focus was a chronic wound on the right foot, complicated by osteomyelitis. Initial intervention involved resection of the first metatarsophalangeal joint (MTPJ) with vancomycin antibiotic beads to control the infection. This was followed by further surgical management to prevent transfer lesions which would lead to further ulcerations, possible infections. Surgical management of painful right foot bunion, metatarsalgia, and hammertoes, including minimally invasive surgical offloading via floating metatarsal osteotomies of the second, fourth, and fifth metatarsals, hammertoe correction of the second and fourth toes, an Akin osteotomy, and flexor and extensor tenotomies. These techniques were chosen to prevent transfer ulcerations and infections, promote healing, and minimize complications ultimately preventing transmetatarsal amputation.
Results: The patient’s wound is with complete closure and the patient no longer experiences pain. The interventions successfully prevented foot amputation and facilitated complete wound healing. Postoperative follow-ups show improved foot function and mobility with no recurrent infections or complications.
Discussion: Minimally invasive surgical approaches are effective in managing complex diabetic foot conditions. In this case, they prevented amputation, ensured wound healing, and resolved pain. These findings suggest minimally invasive surgery as a viable option in similar high-risk patients to enhance outcomes and preserve limb integrity.
013: Real-World Analysis of the Effect of Adjunctive Vaporous Hyperoxia Therapy on the Healing of Chronic Wounds
Submitter: Chase Huskey – Vaporox
Primary Author: David G. Armstrong, DPM
Co-Authors: Marissa Carter, PhD, Adam Isaac, DPM, Dustin Kruse, DPM, Charles Zelen, DPM
Introduction: Vaporous hyperoxia therapy (VHT) is a FDA-510(k) cleared technology used adjunctively with standard wound care. VHT administers a low-frequency, noncontact, nonthermal ultrasonic mist with concentrated oxygen therapy (COT). A retrospective analysis of patients with chronic wounds evaluated the healing effect of VHT.
Methods: We reviewed data of patients with chronic wounds (≥4 weeks) treated with VHT at 10 clinics from February 6, 2020, through August 30, 2022. After debridement (as appropriate), the affected limb was placed in the treatment basin, and a 56-minute treatment of alternating cycles of ultrasonic mist and COT was administered. Wounds were offloaded and dressed appropriately. Twice-weekly treatments occurred until the wound healed (complete epithelialization and granulation). The number of wounds healed at 16 weeks and the percentage area and volume reduction were analyzed. A Kaplan-Meier healing analysis determined time to heal.
Results: Data from 249 patients were reviewed; 40 (17%) patients with 53 wounds were eligible and included. Most patients were male (n = 26, 65%) and aged 65-74 years (n = 21, 53%). The mean [standard deviation (SD)] comorbidity count per patient was 4.6 (2.5). The wounds were predominantly DFUs (n = 47; 88%); 72% (n = 38) of these were Wagner 2 ulcers. Five patients were treated with VHT in combination with ≤5 cellular and/or tissue-based products (CTPs). The median (interquartile range) wound duration was 2.0 months (3.0). The median baseline wound area was 1.5 cm2 (3.9). The median number of treatments was 18 (21); the median treatment length was 60 days (76.5). At 16 weeks, 41 (76%) wounds healed, including all 5 wounds treated with VHT and CTPs. The mean healing time was 14.5 weeks (95% Confidence Interval: 9.9-18.1). The respective mean percentage area and volume reduction over 16 weeks were 69% (156.7) and 82% (70.3).
Discussion: This real-world analysis of patients with multimorbidities demonstrates that VHT healed most chronic wounds within 14 weeks. The hypersaturation and oxygenation of the wound tissue stimulate angiogenesis, reduce bioburden, and accelerate granulation tissue formation. VHT also appears to accelerate healing in wounds that are also treated with CTPs, but this finding warrants further investigation.
014: Diabetes-Related Extremity Amputation Depression & Distress (DREADD)
Submitter and Primary Author: Brandon M. Brooks, DPM, MPH
Co-Authors: Levi M. Brooks, Allison S. Arp, MS, Bradley M. Brooks, DO, Cyaandi R. Dove, DPM, Lee C. Rogers, DPM, Rosemay Michel, DPM, Valentina Clinton, BS, Jonathan Labovitz, DPM, David G. Armstrong, DPM, MD, PhD
Introduction: Of the roughly 38 million people with diagnosed Type 2 diabetes mellitus (T2DM) in the US, up to 34% will develop a diabetic foot ulcer at some point, up to 50% of those who develop an ulcer will experience recurrent ulcers, and approximately 18% of patients with a diabetic foot ulcer will undergo lower-limb amputation (LLA). Given that depression in the diabetic population is associated with non-compliance, poor diet, and increased “no-shows,” we aimed to determine if depressive symptoms change following a minor amputation.
Methods: Our outcome of interest was Patient Health Questionnaire-9 (PHQ-9) scores; the PHQ-9 is commonly used to screen for clinical depression. We conducted a mixed methods study consisting of semi-structed interviews (n=16; table 1) and a retrospective cohort (n=20) of patients with T2DM who underwent a non-traumatic, minor amputation of a single toe (partial or total). PHQ-9 scores were obtained before and after surgery and these scores had to be within 30 days of each other. We utilized the Wilcoxon Matched Pairs Signed-Rank test to determine differences in the PHQ-9 scores prior to amputation and after amputation.
Results: Of the 20 patients in the retrospective cohort, 90% (18/20) had increased PHQ-9 scores within 30 days of amputation. The mean PHQ-9 scores were 3.65 and 12.35 before and after amputation, respectively (a difference of 8.7; P = .0001). There were three major themes from the semi-structured interviews: depression, distress, and barriers to mental health care; non-traumatic amputations can be a traumatic experience for patients. We coined these results as Diabetes-Related Extremity Amputation Depression & Distress (DREADD).
Discussion: DREADD is a potentially dangerous complication of diabetes mellitus. Non-traumatic amputations can be a traumatic experience for patients. Surgeons should screen their patients with T2DM before and after any non-traumatic amputation and make the appropriate referral if necessary. Psychiatrists and other metal health clinicians should be included in multidisciplinary limb preservation teams.
015: Closure of a Diabetic Foot Ulcer with a Fish Skin Graft in a Patient With Multiple Co-Morbidities and Vascular Compromise
Submitter: Michael Romberg – SAS Surgical
Primary Author: Wendy Stephens, ACNP, FCCS
Introduction: This is a 66-year-old female who is a nonadherent patient with diabetes and smoker with PAOD, PVD, HTN, and history of MI x 2 with PTCA and stent placements. This patient presented to the ER in October with cellulitis of her right foot due to a gangrenous right great toe. She had an open wound to her right lateral foot from walking to avoid ambulating on her black toe. CTA showed bilateral SFA occlusions. Due to her labs being normal and the fact that she was not bacteremic, antibiotics were started as an outpatient and a right SFA stent was placed within 2 weeks. She was then taken to OR for a right great toe amputation. The right lateral foot wound was debrided surgically in OR and wound care resumed in clinic.
Methods: The fish skin graft (FSG) was applied once weekly in the wound clinic and secured with a veil, then backed with an absorbent silver hydrofiber (Aquacel), foam borderless dressing, Kerlex, and ACE wrap. She required weekly debridement to prep the wound bed for FSG application with each clinic visit. A total of 7 applications of decellularized fish skin graft was applied to her right lateral foot ulcer over 3 months. She required close monitoring of the right foot due to recent amputation of her right great toe as well. She was instructed to wear a CAM walking boot and came to clinic twice per week. She refused compression wraps after 2 visits and eventually only wore a diabetic shoe due to refusing a walking boot as well.
Results: Within 1 month of 3 applications of FSG to her right lateral foot wound, her ulcer size reduced in width by 50% as she developed granulation tissue that filled in the defect quickly. Drainage decreased as well. Six applications and 2 months later, her foot ulcer was 90% healed. She closed after 7 applications of FSG by end of March.
Discussion: North Atlantic cod fish skin was effective at healing her right lateral foot DFU despite comorbidities, heavy tobacco use, and nonadherence with offloading. She went on to receive 3 more FSG applications for a right heel ulcer that developed 12 months later, which also healed without complications. She remained closed with soft pliable tissue, no contractures, no pain, and minimal scarring. No further skin injuries occurred over the next 1.5 years and she is now deceased.
016: Evaluating the Impact of a Remote Monitoring Service on Limb Salvage Outcomes in Diabetic Foot Management and Care
Submitter: Maria Ryan – Bluedrop Medical
Primary Author: Ronald Scott, MD
Co-Authors: Chris Sandroussi, BA, Chris Murphy, MSc, Maria Ryan, MSc
Introduction: The diabetic foot is a critical and challenging area in diabetes management, with diabetic foot ulcers (DFUs) significantly contributing to lower limb amputations and mortality.1,2 Prompt identification of issues through continuous monitoring is key to effective limb salvage. We have evaluated use of a “smart scale” home use device that remotely monitors patient foot health by capturing daily visual images and temperature data of the soles of the feet to detect risk factors associated with developing a DFU or other complications. This data is used to alert patients to early signs of foot complications and assist clinicians in proactive management of diabetic foot health to mitigate the risk of ulceration and amputation.
Methods: Real world data collection via healthcare providers who enroll patients in the monitoring program. The program includes daily at-home scanning with the device and interactions with the monitoring service team as needed, based on data that may indicate early signs of potential issues. Data from 30 of these patients, enrolled from April to October 2024, is analyzed and reported.
Results: Analysis shows high levels of patient adherence in using the device and engaging with the monitoring service team. The severity of issues identified and addressed are generally low, resulting in reduced cost of care for this highly vulnerable population through early detection and action.
Discussion: This product represents a promising step forward in limb salvage for diabetic patients with peripheral neuropathy. Lifestyle integration of a novel, easy to use remote monitoring technology enables a proactive approach to foot care, potentially transforming outcomes for those at high risk of foot complications.
References
1. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376(24):2367-2375. doi:10.1056/NEJMra1615439
2. Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation. Basis for prevention. Diabetes Care. 1990;13(5):513-521. doi:10.2337/diacare.13.5.513
017: The Prevalence of Diabetic-Related Foot and Lower Limb Amputations at Tertiary Hospitals in Gauteng, South Africa—A Wake-Up Call
Submitter/Primary Author: Simiso Ntuli, PhD
Introduction: There is a significant concern about diabetic foot amputations among both patients and healthcare professionals in South Africa. However, there is a lack of data regarding the prevalence of diabetic foot complications and amputations. This absence of information may contribute to ongoing disparities in care and the absence of a comprehensive strategy to tackle the growing issue of diabetes-related foot amputations.
Methods: A retrospective theatre file review was undertaken for this study with records of all diabetes-related amputations between January 2020 and June 2022 reviewed. Data were analyzed using simple descriptive statistics. The Chi-Square Test was used to determine an association between categorical variables.
Results: A total of 1862 diabetic-related foot amputations were identified from the hospitals’ theater records, but 297 records could not be recovered, leaving 1565 records for analysis. The mean age was 60.5; 62% of patients were males, 26% of amputees were younger than 55, 46% had no direct source of income, and 52% had an income of ZAR70 000 ($4,018) per annum. Seventy-three percent of all first amputations were major amputations, and 75% of these were due to foot sepsis.
Discussion: The data presented in this study were collected from tertiary hospitals in Gauteng, all referral hospitals. The findings indicate a concerning outcome for many diabetic patients. The majority of first amputations were major amputations, which may be attributed to delayed presentations, possibly due to various factors. Among these factors, early access to foot health services and appropriate referral pathways are crucial. There is a need to review the care provided at all levels for diabetic patients. Risk factors should be identified and managed early at the appropriate level of care. The study’s findings reveal a troubling trend: patients undergoing amputations are predominantly under the age of 55, a demographic that should be economically active. South Africa’s healthcare delivery system is primarily the district health system (DHS), which places primary healthcare at the center of healthcare delivery. There is a need to relook at how these facilities or levels of care could be re-engineered to speak to diabetic foot complications early and possibly avoid the ever-increasing number of amputations.
018: Smart Insoles for Preventing Diabetic Foot Ulcers
Submitter: Maria Caluianu – Walk With Path Ltd.
Primary Author: Lise Pape, BSc, MA/MSc, CEO, Walk With Path Ltd.
Co-Authors: Maria Caluianu, BSc, Richard Leigh, DPodM, BSc, MRCPod, FRCPodM, FFPM RCPS (Glasg)
Introduction: About 5.6 million people are estimated to have diabetes in the UK. Twenty-five percent of individuals with diabetes go on to develop diabetic foot ulcers (DFUs) in their lifetimes.1 DFUs take significant time to heal and often lead to amputations. Current DFU prevention methods are inadequate, resulting in 40% of DFUs recurring within a year.2 DFU treatment and amputations also have a significant environmental cost due to the single-use consumables used in assessment and treatment which must be incinerated following use.
Methods: To tackle this, we hypothesize that using smart temperature and pressure sensing insoles to predict DFUs before they form and acting early can prevent DFUs. To this end, user testing was carried out using smart, DFU-predicting insoles*.
Results: The average participant age for user testing was 60.4 years. All users stated that they would act to prevent a DFU if DFU-predicting insoles* alerted them to do so. Most were comfortable with using phone apps and having their data collected and shared with their healthcare providers.
Discussion: We have shown that potential users are ready to adopt such devices into their care. Thus, smart DFU-predicting insoles present a promising device in DFU prevention.
Trademarked Items: *Path Active (Walk With Path Ltd.)
References
1. McKenzie P. North West Coast Strategic Clinical Network: Diabetes Footcare Pathway Blueprint. Published 2017.
2. Voelker R. What are diabetic foot Ulcers? JAMA. 2023;330(23):2314. doi:10.1001/jama.2023.17291
3. Abbott CA, Chatwin KE, Foden P, et al. Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Lancet Digit Health. 2019;1(6):e308-e318. doi:10.1016/S2589-7500(19)30128-1
019: Transforming Powder Dressing (TPD) for Diabetic Ulcer Care
Submitter: Lawrence A. Lavery, DPM, MPH
Primary Author: H. David Gottlieb, DPM, DABPM, FAPWCA, VA Maryland Healthcare System
Introduction: Currently, diabetic foot ulcers (DFU) have no standardized protocols for wound treatment except for offloading. The study “Randomized Clinical Trial to Compare Transforming Powder Dressing (TPD) and Standard of Care (SOC) Dressing Therapies to Heal Diabetic Foot Ulcers” is currently ongoing, funded by the Naval Medical Research Command (NMRC)–Naval Advanced Medical Development (NAMD) via the Medical Technology Enterprise Consortium (MTEC). TPD is a commercially available, FDA registered dressing for wounds that can be left in place for up to 30 days. In the presence of moisture, the powder creates a semipermeable barrier which promotes wound healing as well as preventing contamination of the open tissues. We present 4 patients who have completed the trial at one site.
Methods: Prospective, multi-center, open-label, interventional study comparing the effectiveness of TPD treatment to SOC dressings in subjects with Wagner Grade 1 and 2 DFUs. Subjects were randomized 1:1 to either SOC or TPD. Treatment involved weekly visits with reapplications of TPD as needed. Control group was treated weekly with standard of care treatment, per the podiatrist’s choice. Both groups received appropriate off-loading.
Results: Four male patients with diabetes with Wagner Grade 1 DFUs were enrolled at 1 site with 2 patients were randomized to each group. Subjects, aged 52–79 years, had DFUs for 3 months to over 11 years’ duration. Mean wound size was 1.7 cm2. All ulcers in the TPD treatment group healed. Ulcers in the control group did not.
Discussion: The initial observations of our patient population involved in this study indicate that implementation of TPD treatment in subjects with Wagner Grade 1 DFUs refractory to SOC result in overall wound healing and subject satisfaction. Analysis of additional subjects enrolled in this study will be performed upon study close-out. TPD, in this limited evaluation, has proven to be an effective treatment for Wagner Grade 1 DFUs along with appropriate offloading. TPD is shelf stable and easily applied in the outpatient environment by the clinician. It is well tolerated by the active study population. The author has no financial interest in any product used during the course of treatment.
020: Chronic Nonhealing Combat Injury of the Foot Heals Using Novel Transforming Powder Wound Care Dressing
Submitter: Lawrence A. Lavery, DPM, MPH
Primary Author: H. David Gottlieb, DPM, DABPM, FAPWCA; Kiana Trent DPM, FABPM, FASPS, VA Maryland HealthCare System
Introduction: Several veterans deal with lasting effects of their military service long after discharge, and “their wounds from war are daily facts of life.”1 That was the story of the veteran described here, who dealt with a foot wound from a combat injury for 53 years before enrolling in an ongoing randomized clinical trial funded by the Naval Medical Research Command (NMRC)-Naval Advanced Medical Development (NAMD) via the Medical Technology Enterprise Consortium (MTEC).
Methods: A 75-year-old male with diabetes sustained a high velocity injury to his heel (Vietnam War in 1968). Since the injury, he has had multiple infections, a plethora of standard of care (SOC) and advanced wound care treatments (including skin substitutes), and multiple surgical procedures (including grafts) in attempt to heal the wound. Despite high quality SOC treatment, including a thorough investigation evaluating adequacy of vascular status and nutrition, and smoking cessation, the wound did not completely heal. The patient had been doing daily dressing changes himself and resigned himself to living with a wound the rest of his life. On Sept. 19, 2022, his wound was treated with transforming powder dressing (TPD) for the first time. TPD is an extended wear powder dressing comprised primarily of polymers similar to those used in contact lenses, that when hydrated, aggregate to form a moist oxygen-permeable barrier that covers and protects the wound.
Results: The patient had weekly TPD applications or “top offs” (additional powder sprinkled over existing TPD matrix) on the wound, covered by a nonadherent contact layer and secondary dressing over 7 weeks with only 2 debridements indicated. The wound healed in 52 days (Nov. 9, 2022). The wound has remained healed to date (1.5 years later).
Discussion: Despite quality SOC for years, the wound didn’t heal. Once converted to TPD, the wound healed in less than 2 months, requiring only 2 debridements (less than typical), and has remained healed. Use of novel technology innovations should always be considered, especially when SOC fails. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.
Reference
021: Utilization of Piscine Acellular Dermal Matrix for Coverage Over Tendon and Bone in Diabetics: A Case Series
Submitter: Claire Shea, BS
Primary Author: Ian Barron, DPM, Podiatric Surgeon, Department of Orthopaedics Division of Podiatry UT Health San Antonio
Introduction: Diabetic foot ulcers (DFU) are complex clinical situations and have proven difficult to successfully manage. They are typically associated with high failure rates, amputations, increased morbidity, ultimately creating a considerable burden on health-care resources. Management of lower extremity diabetic wounds include a spectrum of treatment modalities. While useful, they are often associated with complications.1,2 When treating chronic diabetic ulcerations, the wound care provider often turns to advanced allogenic or xenogenic skin graft substitutes for soft tissue coverage. The utilization of xenografts derived from piscine acellular dermal matrix (ADM) has emerged as a promising approach for coverage over tendon and bone defects. Piscine grafts have gained rapid recognition in wound care for their native dermal structural, porosity and biomechanical properties that favors rapid cell ingrowth and provides a natural bacterial barrier rich in Omega-3 fatty acids. This case series aimed to evaluate the efficacy and clinical outcomes associated with the utilization of piscine ADM in a series of patients with tendon and bone defects.
Methods: A retrospective analysis was conducted on a series of 3 patients who underwent surgical grafting using piscine ADM for coverage over tendon and bone defects. Data regarding patient demographics, defect characteristics, surgical technique, postoperative outcomes, and complications were collected and analyzed. Each patient had a history of type 2 diabetes. Each patient had exposed osseous and tendinous structures at the site of graft application. All patients underwent extensive surgical debridement, deep and irregular defects were filled to the level of epidermal tissue with fish skin particulate graft, and then secured with a more traditional sheet form of fish skin graft. Deep cultures were obtained, and antibiotics were initiated, as necessary. Patients received standard of care treatment at routine follow-up until complete healing was obtained.
Results: All wounds had irregular wound surfaces with exposed bone and tendon. Following the first week of initial fish skin graft application complete granulation tissue and coverage of depth, tendon and bone was noted in all. The piscine ADM was successfully integrated and provided adequate coverage in all cases, resulting in improved wound healing, reduced infection rates, and enhanced functional recovery. No cases of graft rejection or significant complications were reported during the follow-up period.
Discussion: Only about 30% of diabetic foot ulcers (DFU) are able to heal within 20 weeks. However, there is promising research indicating that fish skin grafts can play a significant role in improving wound healing outcomes. These grafts contain Omega-3 fatty acids, including EPA and DHA, which help reduce the inflammatory response, enabling the wound to transition from a chronic inflammatory state to an acute one. In a study conducted by Magnusson et al., fish skin grafts demonstrated superior support for the 3-dimensional ingrowth of cells compared to dehydrated human amnion membrane. This suggests that fish skin grafts provide a favorable environment for cell growth and tissue repair. Furthermore, the particulate form of fish skin grafts has shown potential benefits, as it may facilitate more rapid incorporation into the wound site by optimizing the surface area to mass ratio while preserving the three-dimensionality, porosity, and natural complexity of intact fish skin. Our own research findings align with the results of a study by Lullove et al., showing that 67% of DFUs without exposed bone or tendon, treated with weekly fish skin graft sheets alongside standard care, achieved complete closure compared to only 32% in the group treated without fish skin grafts. These promising outcomes suggest that fish skin grafts hold significant promise as an adjunctive therapy for enhancing DFU healing.
References
1. Shakir S, Messa CA 4th, Broach RB, et al. Indications and Limitations of Bilayer Wound Matrix-Based Lower Extremity Reconstruction: A Multidisciplinary Case-Control Study of 191 Wounds. Plast Reconstr Surg. 2020;145(3):813-822. doi:10.1097/PRS.0000000000006609
2. Wagstaff M, et al. Biodegradable temporising matrix (BTM) for the reconstruction of defects following serial debridement for necrotising fasciitis: a case series. Burns Open. 2019; 3(1):12-30. doi:10.1016/j.burnso.2018.10.002.
3. Magnusson S, Winters C, Baldursson BT, Kjartansson H, Rolfsson O, Sigurjonsson GF. Acceleration of wound healing through utilization of fish skin containing omega-3 fatty acids. Today’s Wound Clinic. 2016;10(5):26–29.
4. Margolis DJ, Kantor J, Berlin JA. Healing of diabetic foot ulcers receiving standard treatment: a meta-analysis. Diabetes Care. 1999; 22(5):692–695.
5. Magnusson S, Baldursson BT, Kjartansson H, Rolfsson Yang CK, Polanco TO, Lantis JC 2nd. A prospective, postmarket, compassionate clinical evaluation of a novel acellular fish-skin graft which contains omega-3 fatty acids for the closure of hard-to-heal lower extremity chronic ulcers. Wounds. 2016;28(4):112–118.
6. Magnusson S, Baldursson BT, Kjartansson H, Rolfsson O, Sigurjonsson GF. Regenerative and antibacterial properties of acellular fish skin grafts and human amnion/chorion membrane: implications for tissue preservation in combat casualty care. Mil Med. 2017;182(S1):383-388. doi:10.7205/MILMED-D-16-00142.
7. Lullove EJ, Liden B, Winters C, McEneaney P, Raphael A, Lantis Ii JC. A multicenter, blinded, randomized controlled clinical trial evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers. Wounds. 2021;33(7):169-177. doi:10.25270/wnds/2021.169177
