Fresh Fibroblast Allograft as a Treatment for Diabetic Foot Ulcers

ABSTRACT

PURPOSE: In order to overcome the limitations of the conventional cryopreserved fibroblast or keratinocyte allograft method used in the treatment of diabetic foot ulcers, we reported a pilot study in 2004 demonstrating promising results of a fresh fibroblast allograft method in eight patients. However, the number of cases was insufficient for full evaluation and the follow-up duration was not long enough to determine the efficacy and safety of the method. This encouraged us to conduct this follow-up study to fully evaluate the use of noncryopreserved fresh human fibroblast allografts in treating diabetic foot ulcers. METHODS: Thirty-seven patients with diabetic foot ulcers were treated using fresh fibroblast allografts. Human dermal fibroblasts from healthy teenagers were cultured in DMEM/F-12 medium supplemented with 10% serum. The cultured cells were applied on the wounds immediately following debridement, with fibrin being used as a cell carrier. In eight weeks, percentages of complete healing, mean healing time, and patient satisfactions were assessed, with follow-up time ranging from 6 to 40 months. RESULTS: Our study showed that 83.8% of the treated patients were complete healed. The time required for complete healing was 30.9+/-10.1 days. Patient satisfaction scores for the experimental treatment were higher than those for the conventional method(mean scores of 8.1+/-1.1 and 4.8+/-1.4, respectively). No adverse events related to the study treatment occurred. CONCLUSION: The use of fresh human fibroblast allografts was found to be a safe and effective treatment for diabetic foot ulcers.