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

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Cell and Organ Transplantology. 2021; 9(2):in press.
DOI: 10.22494/cot.v9i2.129

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

Ustymenko A.1,2, Nemtinov P.3,4, Bolgarska S.5, Zaika L.5, Shablii V.4,6, Bukreeva T.4, Orlenko V.5, Palіanytsia S.3

  • 1State Institute of Genetic and Regenerative Medicine, National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine 
  • 2D. F. Chebotarev State Institute of Gerontology, National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine
  • 3Coordination Center for Transplantation of OrgansTissues and Cells, Ministry of Health of Ukraine, Kyiv, Ukraine
  • 4Institute of Cell Therapy, Kyiv, Ukraine
  • 5V. P. Komisarenko State Institute of Endocrynology, National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine
  • 6Institute of Molecular Biology and Genetics, National Academy of Sciences of Ukraine, Kyiv, Ukraine

Abstract

Diabetic foot syndrome with long-term unhealed wounds 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 aim of the study is to evaluate the effectiveness of cryopreserved human amniotic membrane in the treatment of long-term non-healing wounds of the lower extremities in diabetic foot syndrome.
Materials and methods. The pilot clinical study described 4 clinical cases of treatment of patients with diabetes mellitus type I and II (1 woman and 3 men aged 52 to 68 years) with long-term unhealed wounds of the limbs under standard therapy. After previous wound sanation the applications of the cryopreserved human amniotic membrane were performed. Once a week after the application, the dynamics of wound healing was assessed. Blood glucose levels were determined before amniotic membrane treatment and two hours after the procedure.
Results. As a results of weekly applications of human amniotic membrane there was a gradual decrease in the area of the wound from the original size and increase the rate of healing. Thus, at the time of the second visit (after 7 days) the reduction in the area of the ulcer from the initial size in patient 1 was 33 %, patient 2 – 25 %, patient 3 – 33 % on the sole 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.
Conclusions. It has been shown that the use of cryopreserved human amniotic membrane in patients with diabetes mellitus and diabetic foot syndrome with long-term unhealed wounds results in complete healing of ulcers with stable remission during the year of observation.

Key words: diabetes; diabetic foot; cryopreserved human amniotic membrane; tissue therapy 

 

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