The clinical effectiveness of cryopreserved human amniotic membrane in diabetic foot syndrome

Abstract

Diabetic foot syndrome with chronic non-healing ulcers is the most common complication and cause of limb amputation in diabetes. The search for effective therapeutic agents and their inclusion in treatment protocols is a priority due to the increase in the number of cases of this socially significant disease and disability among the working population every year. THE PURPOSE of the study is to evaluate the safety and primary effectiveness of cryopreserved human amniotic membrane in the treatment of chronic non-healing ulcers in diabetic foot syndrome. MATERIALS AND METHODS. The pilot clinical study described 4 clinical cases of patients with diabetes mellitus type I and II (1 woman and 3 men aged 52 to 68 years) with chronic non-healing leg ulcers under standard therapy. After previous wound bed preparation, the applications of the cryopreserved human amniotic membrane were performed. Once a week after the application, the dynamics of ulcers healing was assessed. Blood glucose levels were determined before amniotic membrane treatment and two hours after the procedure. RESULTS. As results of weekly applications of cryopreserved human amniotic membrane there was a gradual decrease in the ulcer area from the initial size and increase the healing rate. Thus, at the second visit (after 7 days) the reduction in the ulcer area from the initial size in patient 1 was 33 %, patient 2 – 25 %, patient 3 – 33 % and patient 4 – 3 %, and the healing rate – 4.7 %, 3.6 %, 4.7 % and 0.43 % per day, respectively. The use of human amniotic membrane did not affect blood glucose levels when comparing values before application and two hours after the procedure. Regular follow-up visits of patients 3, 6, 9 and 12 months after the start of the study showed no recurrence of ulcers. CONCLUSION. It has been shown that the use of cryopreserved human amniotic membrane in patients with diabetes mellitus and diabetic foot syndrome with chronic ulcers results in complete healing of ulcers with stable remission during the year of observation.