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, placebo-controlled 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 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.
RCT Entities:
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, placebo-controlled 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 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.
Authors: Jo C Dumville; Benjamin A Lipsky; Christopher Hoey; Mario Cruciani; Marta Fiscon; Jun Xia Journal: Cochrane Database Syst Rev Date: 2017-06-14