Adequate Debridement and Placental-derived Allograft Treatment Significantly Impact Healing in Chronic Diabetic Foot Ulcers Advances

In a recent study, researchers reviewed data from 2 prospective, multicenter, randomized controlled trials (RCTs) as well as real-world findings via Medicare claims from 2015-2019 to determine how adequate debridement affected healing rates in diabetic foot ulcers (DFUs) treated with placental-derived allografts (PDAs) or standard of care (SOC). In nearly every category evaluated, adequate or more frequent debridement was consistently associated with better outcomes, while use of PDAs also contributed to higher rates of wound closure and lower usage of hospital resources.

Like all wound types, DFUs become chronic wounds when healing stalls during any of the 4 stages: hemostasis, inflammatory, proliferative, and remodeling. The authors of this study note that previous research suggests frequent debridement can reduce inflammation and return a chronic wound to a pseudoacute state, preparing the wound for advanced therapies (ATs), such as PDAs, and allowing the healing cascade to resume.

Yet a lack of standardization surrounding wound debridement means that clinicians have varying opinions on what constitutes adequate debridement. Major studies have shown that ATs, including numerous cellular and/or tissue-based products (CTPs) commercially available in the United States, lead to improved wound closure rates for hard-to-heal DFUs, but previous research on wound debridement excluded wounds receiving these treatments. In this study, Tettelbach and colleagues examined the role of adequate debridement in wound healing among patients with chronic DFUs receiving PDAs compared with SOC, while also comparing the prospective data with real-world results gathered via Medicare claims. 

Researchers began by reviewing data from 2 Institutional Review Board-approved RCTs that occurred in the United States between 2016 and 2018. In these trials, eligibility among patients with a lower extremity ulcer, and previously diagnosed with Type 1 or Type 2 diabetes, was determined during a 2-week run-in period, with those wounds showing no more than 25% reduction in size over this period being included in the study. The 25 study sites included both private clinic and hospital-based settings in diverse areas, and 11 of these sites treated patients in the PDA group with a dehydrated human umbilical cord (DHUC) allograft, while the other 14 used dehydrated human amnion/chorion membrane (DHACM) allograft. The study included 12 weeks of care plus a follow-up visit at week 16.

Patients randomized into the PDA cohort received sharp debridement and application of a PDA, followed by secondary nonadhesive dressings and gauze, while the SOC group received sharp debridement, application of a standard alginate dressing, and similar secondary dressings and gauze. Both groups were given standard offloading in the form of a removable walker boot or total contact cast as appropriate.

To evaluate debridement, images pre- and post-debridement were collected and adjudicated after study completion by 3 outside wound care specialists blinded to both the cohort group and treating clinician. These specialists classified each debridement as adequate if photographic evidence showed attempts to remove necrotic tissue and/or slough from the wound bed, signs of beveling or roughing-up the wound margins in the presence of epibole, pairing of calluses, and no signs of overly aggressive debridement.

Meanwhile, for the real-world results, researchers utilized Medicare Limited Data Standard Analytic Hospital and Outpatient Department Files from 2015 to 2019 to evaluate the frequency of debridement, utilization of hospital resources (inpatient admissions, readmissions, and emergency room visits), and DFU closure frequency. The SOC group was defined as those patients who did not receive a skin substitute as part of their treatment, and a DFU was considered resolved when no new claim activity occurred for 90 days. Included cases were those patients with a confirmed diabetes diagnosis, a lower extremity wound in one location occurring during the study period and treated for more than 90 days, and no confounding events of dialysis or death during the study period or within 90 days after its end.

In the 2 RCTs, 86% of patients in the PDA cohort who received adequate debridement achieved wound closure by 12 weeks, while only 60% of the SOC group achieved wound closure with adequate debridement. Among those who received inadequate debridement, 30% of wounds in the PDA group closed by 12 weeks, while none of those in the SOC group achieved closure. With an overall wound closure rate of 74% among the adequate debridement patients versus 21% with inadequate debridement, the data show a significant correlation (P < .0001) between proper debridement and wound closure, while also reaffirming that treatment with PDA has a notable positive impact on wound healing regardless of debridement.

The Medicare records showed similar results. Researchers compared patients treated with or without DHACM across debridement frequencies of less than 7 days, 8 to 14 days, and greater than 15 days. A debridement interval of 1 to 7 days was associated with shorter length of treatment as well as a 98.6% rate of DFU resolution within 1 year. As intervals increased, so too did length of treatment and use of hospital resources. For those receiving debridement at an interval of greater than 15 days, the 12-month resolution rate dropped to 89.9%. Meanwhile, patients treated with DHACM had lower amputation rates than those treated with SOC, especially when paired with short debridement intervals. These groups were also associated with lower use of hospital resources, and patients receiving debridement at closer intervals received initial DHACM treatment much sooner after initial diagnosis than those with debridement intervals of 8 to 14 days or greater than 15 days.

The study suggests that both the quality and frequency of wound debridement can have significant impact on rates of wound closure among patients with hard-to-heal DFUs. Furthermore, pairing appropriate debridement with PDAs is associated with the highest rates of wound healing and lowest use of hospital resources. The authors note that the size of study populations in the RCTs and lack of data on adequacy of debridement in the Medicare records were limitations, and direct comparisons of RCTs with real-world data are not ideal, but the data are valuable in highlighting areas for further study.

Along with previous data showing improved wound closure rates with use of DHACM and DHUC treatments, this study points to the importance of frequent and adequate wound debridement to further bolster healing rates among patients with chronic DFUs.

“Adequate wound debridement is an essential component of wound care and influences rates of wound closure. The use of advanced therapies such as DHACM or DHUC allografts also promotes closure of hard-to-heal wounds and works best as an adjunct to frequent debridement,” the authors conclude, highlighting the importance of the role of the clinician in creating a favorable environment in which healing can occur.

Study Reference: Tettelbach WH, Cazzell SM, Hubbs B, Jong JL, Forsyth RA, Reyzelman AM. The influence of adequate debridement and placental-derived allografts on diabetic foot ulcers. J Wound Care. 2022;31(suppl 9):S16-S26. doi:10.12968/jowc.2022.31.Sup9.S16