Efficacy and Safety of Fresh Fibroblast Allografts in the Treatment of Diabetic Foot Ulcers

Abstract

Various types of allogenic skin substitutes composed of cryopreserved keratinocytes, fibroblasts, or both have been used for treatments of diabetic foot ulcers, but the effects have generally not been dramatic because cryopreservation impairs cell activities. The purpose of the study was to evaluate the use of non-cryopreserved fresh human fibroblast allografts in treating diabetic foot ulcers. Human dermal fibroblasts from healthy teenagers were cultured and applied over the foot ulcers of 37 patients with diabetes. Control treatment was performed in 18 patients. Eight weeks after treatment, the percentages of complete healing, mean healing times, and patient satisfaction were compared, with follow-up ranging from 6 to 40 months. Our study showed that 83.8% of the treated group and 50.0% of the control group experienced complete healing. The times required for complete healing were 30.9+/-10.1 and 47.2+/-7.8 days in the treated and control groups, respectively. Patient satisfaction with fresh fibroblast treatment was also superior to satisfaction with the conventional method (mean scores: 8.0+/-1.0 and 4.9+/-1.4, respectively). No adverse events related to the study treatment occurred. The use of fresh human fibroblast allografts was found to be a safe and effective treatment for diabetic foot ulcers. The authors have indicated no significant interest with commercial supporters.