Use of fetal bovine dermal repair scaffold in diabetic foot ulcers with recidivism: an open-label prospective clinical study

Abstract

Objective: This study aimed to establish the effectiveness of fetal bovine dermal scaffold (FBDS) application with multilayer offloading (standard of care) over that of traditional therapies in the treatment of diabetic foot ulcers (DFUs). Method: Patients from a single centre in South Florida, US were recruited for this research. All patients underwent a run-in period of standardised care and vascular testing to determine and control the ability to heal. Patients were placed in multilayer offloading total contact cast (TCC) systems with application of FBDS every four weeks. Wound measurements and efficacy of offloading were monitored weekly. Results: In an older population with diabetes and above-normal body mass index (BMI), use of FBDS was successful in wound closure, with average time to closure of 7.85 weeks for the 20 patients in this study. It should be noted that surface wound area was reduced by approximately 40% by week 4 and by almost 83% by week 9. Follow-up at three and six months showed no residual or recurrent ulcerations in this study population for 19/20 patients. Conclusion: Total wound closure of hard-to-heal DFUs in this patient series study was achieved with local surgical debridement, TCC offloading and application(s) of a FBDS in older patients with above-normal BMI and in wounds of >4 weeks non-progressive healing. Furthermore, at three and six months, 19/20 patients' wounds remained closed and did not re-ulcerate.