Use of human umbilical cord acellular matrix for soft tissue defects in patient with diabetic foot syndrome (case report)

Non-healing ulcers pose a serious problem for public health due to the high cost of treatment, prolonged disability of patients, and low efficacy of therapy. They are the leading cause of non-traumatic lower limb amputations.

The development of innovative bioengineering products is a significant step in the treatment of non-healing diabetic foot ulcers. One such product is a tissue-engineered acellular product made from highly regenerative human umbilical cord biomaterial. It contains growth factors, cytokines, and components of the extracellular matrix of Wharton’s jelly, which accelerates wound healing.

THE AIM of this clinical study is to evaluate the safety and efficacy of a tissue-engineered acellular product from Wharton’s jelly of the umbilical cord for the treatment of chronic non-healing lower limb ulcers in patients with diabetic foot syndrome.

RESULTS: a 60-year-old woman diagnosed with type 2 diabetes mellitus had chronic ulcers that had not responded to standard treatment for more than a year and a half. She was observed for 4 weeks in August 2024. As a result of the local application of an acellular product from human umbilical cord, signs of reduction in wound size and their complete healing were noted 4 weeks after the start of observation.

CONCLUSION: clinical observation has demonstrated the safety and efficacy of the acellular product from human umbilical cord for the treatment of chronic non-healing ulcers of diabetic origin.

1. International Working Group on the Diabetic Foot (IWGDF) Guidance. DiabetesMetabResRev. 2019;36

2. International Diabetes Federation. IDF Diabetes Atlas. 10th ed. Brussels: International Diabetes Federation; 2021. 168 p

3. Armstrong DG, Boulton AJ, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017;376(24):2367-2375

4. Ma Z, Wang P, Zhan L. The application of tissue-engineered biomaterials in wound healing. Int J BiolMacromol. 2021;184:340-356

5. Kondratenko AA, Tovpeko DV, Volov DA, et al. Decellularized Umbilical Cord as a Scaffold to Support Healing of Full-Thickness Wounds. Biomimetics. 2024;7(9):405. doi: https://doi.org/10.3390/biomimetics9070405

6. Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I, et al. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. 2016;5:CD006899

7. Badiavas EV, Falanga V. Treatment of chronic wounds with bone marrow-derived cells. Arch Dermatol. 2003;139(4):510-516

8. Frykberg RG, Gibbons GW. The Diabetic Foot: Evaluation and Management. Curr Treat Options Cardiovasc Med. 2006;8(2):151-164

9. PatentRUS №2816034 / 25.03.2024. Khominets VV, Kalyuzhnaya-Zemlyanaya LI, Kondratenko AA, Tovpeko DV, Zemlyanoy DA, Volov DA, Chebotarev SV. Method of using a cell-free lyophilized product from the human umbilical cord for wound healing. (in Russ.)

10. PatentRUS №2795904 / 15.05.2023. Kalyuzhnaya-Zemlyanaya LI, Tovpeko DV, Kondratenko AA, Zemlyanoy DA, Chernov VE, Chebotarev SV, Volov DA. Method of manufacturing a cell-free matrix from the human umbilical cord to create a highly regenerative wound covering. (in Russ.)