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Objective: To determine the efficacy and safety of short- contact administration of topical tretinoin on foot ulcers in patients with diabetes. Design: Randomized, double- blind, placebocontrolled trial. Setting: Outpatient clinic at a Veterans Affairs medical center. Patients: Twenty- four volunteers with diabetic foot ulcers but without evidence of peripheral arterial disease or infection. Interventions: Patients were randomized to 4 weeks of daily treatment with either topical 0.05% tretinoin solution (Retin- A) or placebo saline solution. Photographs and assessment of wound size and appearance were assessed every 2 weeks for a total of 16 weeks. Main Outcome Measures: The proportion of ulcers that healed in each group and the degree of change in ulcer size. Results: Twenty- two patients, with a total of 24 foot ulcers, completed the study. At the end of 16 weeks, 2 (18% ) of 11 ulcers in the control group and 6 (46% ) of 13 ulcers in the tretinoin treatment group healed completely. Topical tretinoin therapy significantly decreased ulcer area and depth compared with placebo treatment over the 16weeks of the study (P < .01 for surface area; P=.02 for depth). Adverse effects mainly consisted of mild pain at the ulcer site. Conclusions: Short- contact application of topical tretinoin improved the healing of foot ulcers in patients with diabetes. The tretinoin therapy was generally well tolerated, without serious local or systemic adverse effects.
Objective: To determine the efficacy and safety of short-contact administration of topical tretinoin on foot ulcers in patients with diabetes. Design: Randomized, double- blind, placebocontrolled trial. Settings: Outpatient clinic at a Veterans Affairs medical center. Patients: Twenty- Four volunteers with diabetic foot ulcers but without evidence of peripheral arterial disease or infection. Interventions: Patients were randomized to 4 weeks of daily treatment with either topical 0.05% tretinoin solution (Retin-A) or placebo saline solution. Photographs and assessment of wound size and appearance were assessed every 2 weeks for a total of 16 weeks. Main Outcome Measures: The proportion of ulcers that healed in each group and the degree of change in ulcer size. Results: Twenty- two patients, with a total of 24 foot ulcers , completed the study. At the end of 16 weeks, 2 (18%) of 11 ulcers in the control group and 6 (46%) of 13 ulcers in the tretinoin treatment group healed completely. Topical tretinoin therapy significantly decreased ulcer area and depth compared with placebo treatment over the 16 weeks of the study (P <.01 for surface area; P = .02 for depth). Adverse effects mainly consisted of mild pain at the ulcer site. Conclusions: Short- contact application of topical tretinoin improved the healing of foot ulcers in patients with diabetes. The tretinoin therapy was generally well tolerated, without serious local or systemic adverse effects.