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Randomized, controlled, single-blind study on use of autologous keratinocytes on a transfer dressing to treat nonhealing diabetic ulcers.
Moustafa M, Bullock AJ, Creagh FM, Heller S, Jeffcoate W, Game F, Amery C, Tesfaye S, Ince Z, Haddow DB, MacNeil S. Regen Med. 2007 Nov;2(6):887-902
AIM: To compare the rate of healing of diabetic neuropathic ulcers using cultured autologous keratinocytes delivered on chemically defined transfer discs (Myskin) (active treatment) versus healing obtained with cell-free discs (placebo).
MATERIALS AND METHODS: After a 4-week lead-in period patients (randomly assigned) received active or placebo treatments weekly for 6 weeks. All patients then received active treatments for a maximum of 12 treatments where required. Altogether, 16 patients with a total of 21 ulcers resistant to conventional therapy were recruited from four specialist diabetic centers in three cities.
RESULTS: All 21 ulcers were treated and of these ten healed and eight improved, with two failing to respond (one ulcer was lost due to autoamputation). For analysis according to the study criteria, however, only the 12 patients with 12 index ulcers who completed treatment protocols were eligible - five in the placebo group and seven in the active group. Of these, five ulcers healed completely and seven were reduced by more than 50%. Complete healing took a median of ten active applications.
CONCLUSIONS: Repeated regular applications of the patient's keratinocytes, delivered on the carrier dressing, initiated wound healing in ulcers resistant to conventional therapy, with 18 out of 21 ulcers responding. The healing observed did not appear attributable to patient recruitment or the cell-free carrier dressing but to the delivery of the cultured cells.
Diabetic foot ulcers often pose a difficult treatment problem. Repeated applications of cell-based products have been reported to result in acceleration of diabetic wound healing. The purpose of this clinical trial study was to report preliminary findings of the efficacy and safety of the cultured allogeneic keratinocyte sheets in the treatment of diabetic foot ulcers. Fifty-nine patients with diabetic foot ulcers were randomized to either the keratinocyte treatment group (n = 27) or the control group treated with vaseline gauze (n = 32). Except for the application of keratinocytes, treatment of study ulcers was identical for patients in both groups. Either keratinocyte sheet or vaseline gauze was applied at the beginning of the study and weekly thereafter for a maximum of 11 weeks. The maximum follow-up period for each patient was 12 weeks. Complete ulcer healing was achieved in 100% of the treatment group and 69% of the control group (p < 0.05). The Kaplan-Meier median times to complete closure were 35 and 57 days for the keratinocyte and control groups, respectively. No adverse events related to the treatment occurred. These results indicate that cultured allogeneic keratinocytes may offer a safe and effective treatment for diabetic foot ulcers.