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To evaluate the efficacy and safety of applied autologous circulating fibrocytes in the treatment of non-healing diabetic foot ulcer; a pilot study
The aim of this study is to evaluate a new cellular therapy for the treatment of chronic non-healing diabetic wounds. 20 patients affected with the type II DM, with the wet wounds, about 2-6 cm2, resistant to treatment despite of the comprehensive treatments for at least 6 weeks, wounds in the grade II, III and IV based on the Wagner classification method, without osteomyelitis, cellulits, or any kind of the local and systemic infection and no other underlying disease rather than DM (as autoimmune diseases) will be selected. 10 patients in the test group will receive once cellular graft with dressing (cell suspension). The dressings will be changed every 7 days up to the 8th week or the complete wound healing. The other 10 patients in the control group will receive dressing without cellular graft. Wound healing will be assessed by the evaluation of the changes of the wound dimensions and need to amputation.
IRCTID: IRCT138812133487N1
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