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INVESTIGATION THE SAFETY OF AMNIOTIC MEMBRANE EXTRACTS To IMPROVE DIABETIC FOOT ULCERS (PHASE 1 CLINICAL TRIAL STUDY)

Mohammad Azimi Alamouti

This study was an Open labeled clinical trial without control group. A total of 10 patients with Wagner Grade 2 diabetic foot ulcers were selected in both sexes. The extract was used every 48 hours in the first week and every 72 hours from the second week until the end of the wound treatment. Patients were followed up weekly until wound healing. Results: In this study 80% of patients were men and 20% were women with mean age (56.7 ± 8.7) years. The ulcer duration was 8.9 ± 2.12 weeks. The mean area of ulcers at the time of entry into the wound group ≥ 500 mm2, 977.5 ± 201.9 and in the wound group ≤500 mm2 was 145.6 ± 36.4. At 4 weeks post treatment, the wound healing rate in the wound group was ≤500 mm2, 98.9 ± 2.40 % and in the wound group ≥mm2 500 was 92.1 ± 7.23%. In sixth week of treatment, ulcers were complete closure in both groups.