Search

Background: Diabetic foot ulcers are chronic, difficult to heal, and potentially life-threatening. Few medical devices have been studied in diabetic ulcers penetrating to bone or tendon. Methods: We conducted an international, open-label randomized controlled trial, randomly assigning patients with diabetic ulcers penetrating to bone, joint, or tendon 1:1 to intact fish skin graft or standard wound care, with assigned treatment applied through 14 weeks. The primary end point was the proportion of ulcers healed at 16 weeks, defined as reepithelization as identified by the investigator, and confirmed 14 days later. A blinded adjudication committee confirmed healing at both time points. Healing was also assessed at 20 and 24 weeks. Results: Between July 2020 and November 2022, 255 patients were randomly assigned to intact fish skin graft (n=129) or standard of care (n=126). Healing was achieved in 44% of patients at 16 weeks with intact fish skin graft compared with 26% for standard of care (P<0.001, unadjusted), with additional healing at 20 weeks (46% vs. 32%) and 24 weeks (55% vs. 38%). Mean (SD) time to healing was 17.3 (0.69) weeks (95% confidence interval [CI], 15.5 to 18.7) for the intact fish skin graft group and 19.4 (0.66) weeks (95% CI, 18.1 to 20.7) for the standard of care group. In a Cox regression, intact fish skin graft was associated with faster time to healing (hazard ratio, 1.59; 95% CI, 1.07 to 2.36). Primary wound infections were the most common adverse event, occurring in 39 (30.2%) of patients in the intact fish skin graft group and 31 (24.6%) of patients in the standard of care group. Conclusions: Among patients with deep diabetic foot ulcers, treatment with intact fish skin graft was superior to standard of care in proportion of wounds healed at 16 weeks and was associated with faster time to healing. (Funded by European Commission Fast Track to Innovation Horizon 2020, and Kerecis Ltd. ClinicalTrials.gov NCT04257370.) [ABSTRACT FROM AUTHOR]

Background. Chronic lower extremity (LE) wounds frequently require significant interventions to close. The success of any method depends on an adequately prepared wound bed, while factors including wound size, perfusion, contamination, or exposed tissue structures can thwart efforts. We propose a standardized algorithm of care utilizing an acellular dermal matrix, split-thickness skin graft (STSG), and negative pressure wound therapy (NPWT) for the treatment of LE wounds. Methods. This was a single-center, retrospective cohort study examining patients who underwent LE wound debridement, placement of fetal bovine dermis (FBD), and STSG between 2016 and 2022. The primary outcome was wound closure, while secondary outcomes were wound infection and amputation-free survival. Results. Twenty patients (mean age 59 years, M:F 12:8)--including 24 LE venous ulcers (29.4%), amputation sites (29.4%), diabetic foot ulcers (25.0%), and atypical wounds (16.7%) with an average area of 39.15 cm²--underwent debridement and FBD placement followed by STSG a median of 61 days thereafter. Of these patients, 83.3% received NPWT after FBD and STSG with 86% closure. There was successful engraftment in 92% of wounds whose FBD placement was within 2 months of STSG. Of wounds that had <50% engraftment, 75% had a STSG placed over 2 months after FBD placement. Of those patients with post-STSG infection, 75% had the graft placed >2 months after FBD placement, one of which required proximal amputation. Conclusions. By following a treatment plan including debridement with treatment of infection, application of FBD with placement of STSG within 2 months thereafter, and reinforcing NPWT, chronic wounds will have an increased rate of successful reepithelialization. Many cases experienced delays from FBD engraftment until STSG application due to schedule and insurance impediments, which led to less favorable outcomes. Therefore, a protocol that involves scheduling the placement of STSG 4 weeks after successful engraftment of FBD has been adopted. [ABSTRACT FROM AUTHOR]