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Using a Programmable Pneumatic Device with Truncal Therapy to Facilitate Wound Healing: A Case Series
Abstract
Chronic, recurring limb ulcers require a comprehensive approach that addresses the wound pathology, vascular status, and swelling. Although studies have shown that compression, especially high compression, is more effective than dressings alone, evidence to support one particular method of compression is limited.
A sequential intermittent pneumatic compression (IPC) device was evaluated in four patients (two men, two women, age range 47 to 59 years) with nonhealing (history of 1 to 6 months) venous insufficiency (n = 2), postsurgical complication (n = 1), and radiation burn (n = 1) wounds and minimal to extensive clinically observable edema. All patients received standard wound care (debridement and/or appropriate dressings). Wounds were protected with an anti-shear wound dressing during pneumatic treatment. Each week, the various wounds and limb girths decreased until the site healed or limb volume normalized for that individual; 100% of the wounds healed. One patient, who had minimally observable edema, also responded positively when IPC was added to his standard wound care regimen. The pneumatic system was well tolerated in all patients. The results obtained suggest that combining appropriate standard wound care with this IPC treatment may facilitate closure of chronic, nonhealing wounds. Additional studies are needed to ascertain the effectiveness and cost-effectiveness of this treatment modality.
Chronic recurring limb ulcers are associated with significant morbidity and require intensive and costly care.1-4 They often result from venous insufficiency or from cancer therapies or surgeries that disrupt lymphatic function; they are challenging to heal.5-8 The lymphedema commonly associated with ulcers contributes to the overall pathology of the disease, creating a need for a comprehensive therapeutic approach that addresses both the wound itself and regional swelling.8,9
The use of compression in the treatment of nonhealing lower extremity wounds not associated with arterial insufficiency is widely accepted.2,3,5,9,10 The aims of compression treatment are to 1) enhance venous pump function and blood return to the heart, 2) reduce edema by elevating tissue hydrostatic pressure, and 3) encourage the flow of lymph fluid from the damaged tissues into functional drainage regions.4,7,8,10 Compression treatments vary in overall configuration, materials used, and type and amount of pressure generated.1 A variety of garments providing continuous compression to the limb are in clinical use, including Unna’s boot (Smith & Nephew, Quebec Canada), roller bandages, and hosiery.1,5,11 The various compression methods used in ulcer healing have been compared in published and unpublished randomized controlled trials, the results of which have been analyzed in two systematic reviews.1,11 Despite a variety of study limitations, the results of these reviews suggest that high compression is more effective than low compression and that multilayer compression is more effective than single-layer compression.1
In addition to compression wraps and garments, older generation, simple pneumatic devices delivering continuous or intermittent compression to the tissues have been used. Use of three such devices was recently reviewed by Berliner et al5 and Kalodiki.12 Pooled data from three randomized studies13–15 of venous ulcer healing analyzed by Nelson et al11 found that intermittent pneumatic compression in combination with continuous compression yielded no better results than continuous compression alone. A fourth randomized study16 of venous ulcer healing was excluded from the analysis in the Nelson systematic review due to an excess contribution to statistical heterogeneity; this study showed a significant relative risk (95% confidence interval) of 11.43 (1.59, 82) favoring healing with intermittent pneumatic compression, even with consideration of the higher median lesion size at baseline in the group receiving intermittent pneumatic compression along with continuous compression.11 For lower extremity wounds, no conclusive clinical comparisons between intermittent pneumatic compression alone and continuous compression alone have been identified.
As illustrated, evidence from randomized clinical trials is insufficient to support decisions as to which compression devices are most beneficial for the treatment of lower extremity open wounds accompanied by edema. Although the physiological basis is ample to support features provided by advanced pneumatic devices, including the programmability and adjustability to address individual patient needs, components not available in traditional nonprogrammable devices, more clinical experience, and studies comparing available methods and devices are needed.1,5,9
In contrast to leg wounds primarily of venous origin for which compression is a well recognized treatment modality, compression as part of treatment of nonhealing trunk wounds related to prior surgery or other causes such as radiation has not been widely reported. However, a compelling case for the use of compression as a means to facilitate general wound healing by diminishing the retarding effects of periwound edema has been presented.8 The authors suggest that such periwound edema often is not visually apparent but none-the-less contributes to stalled or absent wound healing.
The Flexitouch® (FT) system (IPC, Tactile Systems, Minneapolis, MN) is a pneumatic device that provides intermittent pneumatic therapeutic compression to the limbs and trunk and is intended for use in the treatment of primary lymphedema, post-mastectomy edema, edema following trauma and sport injuries, post-immobilization edema, venous insufficiencies, lymphedema, and wounds.17 Therapy consists of the dynamic application of mild pressure over small therapeutic areas.
This IPC system differs from older generation intermittent pneumatic compression devices in several ways. Its mode of action is designed to first provide sequential proximal treatment, including truncal lymphatics (thereby, providing proximal decongestion during a preparation phase) and only then followed by sequential limb (arm or leg) drainage phase. The importance of this initial proximal decongestion phase recently has been discussed.18 Decongestion is accomplished using specially designed trunk and limb-segmented garments that sequentially apply a mild therapeutic work-and-release pressure pattern according to selectable programmable pressure sequences. Consistent with the governing physiological principles of the lymphatic system,18 light, variable, directional pressure is applied to the trunk and affected limb using multichambered, inflatable, stretchable garments. The inflation/deflation cycle applies a brief stretch against the skin in the desired direction, stimulating lymphatic flow. In this way, lymphatic anastomoses is utilized in order to direct lymph fluid along existing anatomical pathways from areas where flow is deficient to normally functioning regions. The shorter-acting, work-and-release mechanism pressures are markedly different from older generation compression pumps and demonstrate a sequential pattern that mimics manual lymphatic drainage.19 Preliminary results of a crossover study of 10 women with secondary lymphedema suggest that FT IPC may be effective in the treatment of breast cancer-related lymphedema20 and is well accepted by patients.21
The purpose of this report is to describe the clinical outcomes achieved in four patients with chronic nonhealing wounds of differing etiologies between May 2006 and March 2007 when the FT IPC system was used in combination with standard wound treatment.
Case Series
Quantitative measures. In all four patients, wound areas were estimated as the maximum length (L) x maximum width (W) perpendicular to the length. For patient MK, who had a deep wound, wound volume was estimated as L x W x depth. Circumference measurements were taken at 10-cm intervals along the affected leg or, in the case of the trunk wound (patient YH), along the ipsilateral arm. Limb volumes were calculated from the circumferences using a validated commercial software algorithm (www.limbvolumes.org). Patients were selected to receive IPC treatment with the US Food and Drug Administration (FDA)-approved use of the pneumatic device based on the clinical 
judgment of the therapist and physician. This was not a prospective evaluation; this was prescribed care. However, when the results of treatment were observed to be noteworthy, the clinician obtained written consent from each patient in order to create a case study of observed outcomes using the prescribed treatment.
Patients.
Patient WN. WN was a 59-year-old man with long-standing deep vein thrombosis and a nonhealing venous leg ulcer 19 cm below the knee with minimal edema that measured 2.2 cm x 2.3 cm x 0.1 cm before debridement. At the initiation of treatment, no granulation tissue was visible. WN was treated with sharp debridement and dressings, the latter including Arglaes powder (Medline, Mundelein IL), Adaptic (Medline, Mundelein IL), and Unna’s boot. After 1 month of slow progress with standard treatment, Doppler was performed to rule out lower extremity arterial disease or deep vein thrombosis; pneumatic compression was initiated. During compression treatment, the wound was covered with an anti-shear dressing (Exu-Dry™, Smith & Nephew, Quebec, Canada). All other treatment components remained the same. Tissue granulation improved from 50% to 85% after two treatments; WN received one treatment per day, 3 days a week. After 4 weeks of IPC treatment, the wound site exhibited 100% beefy red granulation tissue (see Figure 1). Mid-study, WN’s wound exhibited a transient increase: the wound measured 2.8 cm x 2.5 cm x 0.1 cm and limb volume increased from 2,465 mL to 3008 mL, coinciding with a 4-week interruption of IPC therapy. This interruption, which began at week 4, was due to an infection at the site of previous deep vein thrombosis. Doppler imaging indicated no deep vein thrombosis but antibiotics were initiated to address the infection. Clinic policy is to treat infection for 48 hours before resuming compression; however, the physician wanted to wait until all signs and symptoms were clear (approximately 4 weeks), which is when limb volume was the highest. The infection was not attributed to IPC usage and treatment was resumed at completion of the course of antibiotics (week 8); limb volume decreased and the wound healed (see Figure 2).
Patient MK. MK was a 54-year-old man who developed a nonhealing small (in area) but deep wound (0.5 cm x 0.5 cm x 5.9 cm) on the anteriomedial aspect of his left thigh 3 cm below the limb junction as a complication of abdominoplasty following gastric bypass surgery. Drain insertion yielded profuse drainage but no progress toward wound closure. MK was referred to the wound center. The wound had been present for more than 2 years. Significant lymphedema of the trunk accompanied by excessive fluid exudate precluded effective use of compression dressings. Manual lymphatic drainage was not a viable option because the patient was not able to perform the required treatment. MK also exhibited bilateral lower extremity lymphedema. IPC treatment of the trunk and bilateral lower extremities was implemented twice weekly during clinic visits in combination with Silvercel Antimicrobial Alginate Dressing (Johnson & Johnson, Langhorne, PA), anti-shear dressing, and compression wraps. MK experienced a rapid reduction in wound depth (August 29, depth = 5.9 cm; September 26, depth = 4.5 cm; November 2, depth = 3.9 cm; November 9, healed) and achieved a 21-cm reduction in abdominal circumference. Measurements of wound depth together with wound area were used to estimate and plot the changes in wound volume along with leg volume (see Figure 3). MK continued use of the IPC system at home and was able to return to work.
Patient RS. RS was a 57-year-old woman with chronic venous insufficiency, lymphedema, and a venous leg ulcer associated with 3+ pitting edema at the tibial crest 5 cm below the knee. She was hypertensive, had congestive heart failure, and was unable to control the large edema volume with an older-generation compression pump. RS was referred to the wound clinic with a wound of 4 months duration that continued to worsen. At start of care May 4, the wound measured 1.5 cm x 10.5 cm [120.75 cm2] x 0.5 cm. Treatment with sharp debridement, periwound barrier cream, and antimicrobial alginate dressing was initiated in combination with IPC treatment using the full lower extremity garment set, including the trunk garment. Treatments were provided weekly because RS had transportation difficulties. During IPC treatment, the wound was covered with an anti-shear dressing. Initiation of FT was accompanied by rapid decrease and stabilization of leg volume and a parallel reduction in wound area to closure (August 17, area = 4.56 cm2; the wound closed October 12. See Figure 4). RS also was able to return to work after a 3-month absence necessitated by her nonhealing wound.
Patient YH. YH was a 47-year-old woman with a nonhealing wound on the anteriolateral aspect of the thorax extending into the axilla that developed secondary to radiation injury following radical mastectomy. The wound worsened with self-administered manual lymphatic drainage and a traditional compression garment. After 6 months with no healing, YH was referred to the wound care center. At start of care July 10, the wound measured 3.6 cm x 7.3 cm x 1.2 cm and limb volume measured 1,543 mL (2 weeks later, limb volume measured 1,275 mL). Her range of motion was limited in her shoulder, wrist, and hand and the wound was tender to the touch. She was treated with enzymatic debridement and IPC three times during her first week of treatment in the clinic. An anti-shear dressing was applied to the wound area during IPC treatment. Thereafter, YH was seen three times weekly; her treatment at the clinic consisted of wound cleansing/debridement and 1 hour of IPC treatment on her left arm, chest, and trunk. Compression wraps were used between clinic visits. At initiation of FT, YH experienced rapid reduction in arm volume that stabilized after week 2 and a steady decline in wound area until closure at approximately week 6 (see Figure 5). YH continued with chemotherapy during her treatment at the wound care center. She reported improved quality of life because of wound closure, although she succumbed to cancer approximately 2 months after her wound treatment ended.
Discussion
In the cases described, IPC was used to treat open wounds arising from venous insufficiency (WN, RS), complications of surgery (MK), and radiation treatment (YH). The wounds varied considerably in the amount of edema associated with the affected area at the time of referral to the author’s clinic. Each of the four patients treated with the combination of standard wound care and the pneumatic device achieved wound closure despite initial classification of the wounds as nonhealing.
Of particular note is patient WN. This patient had little edema at initiation of IPC treatment and limb volume did not change much throughout the course of therapy. Even so, his ulcer reduced remarkably in size and the wound healed. Thus, while the pneumatic device was not used to reduce edema in this patient, the wound responded favorably when IPC was added to standard wound care. This observation may be attributable to reduction in periwound edema, not clinically visible yet in part responsible for inhibiting timely wound healing as previously posited.8
At the time of this report, the three surviving patients have continuously used the IPC system for 1.5 to 2 years with no recurrence of their wounds. Two of these patients will have to provide lifelong management of their lymphedema; one uses it to manage the edema secondary to chronic venous insufficiency. This is not unusual protocol — many patients require lifelong treatment for ongoing lymphedema issues. The system was well tolerated by all patients. Of note, insurance carriers for all three surviving patients provided payment for the IPC system. Coverage criteria for advanced pneumatic devices include documentation of: 1) wounds that have failed to heal after a 6-month trial of conservative therapy that must include a compression bandage system or compression garment, appropriate wound dressings, exercise, and elevation; 2) documentation of regular physician visits over the 6-month period; 3) trial of a nonprogrammable pump and reasons why that device failed to provide effective treatment or alternatively that use of a nonprogrammable pump was evaluated and ruled out due to the patient’s unique physical characteristics, and 4) trial of the prescribed device to demonstrate the patient can tolerate treatment and can apply the device independently or with caregiver assistance.
The limited sample size precludes a comparison between outcomes reported in the literature and those observed in this case series.
Conclusion
The results of a four-patient case series to assess use of IPC suggest that the combination of appropriate standard wound care with advanced pneumatic treatment may facilitate healing of difficult-to-treat wounds arising from venous insufficiency and other etiologies. In addition, it was observed that the addition of IPC may facilitate healing when edema of the affected area is minimal. Randomized, controlled clinical studies are needed to ascertain the effectiveness of this IPC treatment modality compared to standard wound care alone and/or older pneumatic devices.
Ms. Betz is Clinical Manager of Rehabilitation Services, University Medical Center at Brackenridge, Austin, TX. Please address correspondence to: Caren Betz, PT, 601 East 15th Street, Austin, TX 78701; email: CBetz@seton.org.
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