Cultured allogeneic skin cells are effective in the treatment of chronic diabetic leg and foot ulcers

Diabetic ulcers on the lower extremities present a difficult treatment prob lem, and some ulcers respond poorly to conventional topical and cast treatm ent. The purpose of this study was to assess the effect of cultured allogen eic keratinocyte epithelium and fibroblast-gelatin sponge on the healing of chronic, refractory diabetic leg and foot ulcers. Non-diabetic chronic leg ulcers mere treated for comparison, This open study comprised 22 patients with type I or type II diabetes and 16 patients with leg or ankle ulcers of different aetiologies, A total of 26 diabetic and 25 non-diabetic ulcers m ere treated mainly with keratinocyte epithelium and/or fibroblast-gelatin s ponge once weekly until complete healing or until no further healing could be observed despite several repeated treatments, The duration of diabetic u lcers was 10.3 +/- 15.8 (mean +/- SD) months and the size 3.1 +/- 6.6 cm(2) . The diabetic ulcers were located in the heel (7), toe (7), sole (5), leg (6) and Achilles (1). The mean duration of non-diabetic ulcers was 6.8 +/- 6.0 months and the size 10.5 +/- 11.8 cm(2), A total of 12 +/- 11 skin cell transplantations were performed for the diabetic ulcers, All but 1 diabeti c ulcer healed during the study. The time for 50% reduction in ulcer area w as 32 +/- 32 days, but 99 +/- 110 days were needed for complete ulcer closu re. The longer the ulcer had existed the longer was the healing time, Heel ulcers showed significantly slower healing response than leg, sole and toe ulcers, Preliminary results suggest that both keratinocytes and fibroblasts are equally effective in the healing process, The time required for healin g of the diabetic ulcers did not differ markedly from that of the non-diabe tic ulcers. The results suggest that cultured allogeneic skin cells used on ce weekly are effective in the treatment of recalcitrant diabetic ulcers.