Re-Epithelialization of Neuropathic Diabetic Foot Wounds with the Use of Cryopreserved Allografts of Human Epidermal Keratinocyte Cultures (Epifast)

Abstract

The application of tissue-engineering technology to wound healing has become an option for the treatment of diabetic foot ulcers (DFU). A comparative, prospective study was conducted to assess the efficacy of a cryopreserved allograft of human epidermal keratinocytes (Epifast) to enhance wound healing in granulating DFU. Eighty patients were assigned to receive Epifast (n = 40) or Standard Care (SC) treatment (n = 40). The Epifast group displayed a shorter duration of the epithelialization phase (3.5 ± 4 vs. 6.4 ± 3.6 weeks, p < 0.05) and upon the entire wound healing process than the SC group (10 ± 5.7 vs. 14.5 ± 8.9 weeks, p < 0.05), reaching wound closure at 16 and 30 weeks, respectively. The Kaplan–Meier analysis revealed that Epifast group patients were 50% more likely than the SC to heal wounds faster (Cox-hazards ratio of 0.5, 95% CI = 0.3–0.8, p < 0.0001; Likelihood Ratio of 7.8. p < 0.05). Patients in the control group displayed a slower healing as the Saint Elian (SEWSS) severity grade increased (group differences of 0.6, 3.8, and 4.3 weeks for grades I, II, and III, respectively). DFW treated with Epifast displayed a shorter time to complete re-epithelialization than wounds treated with standard care.