Live stem cells from fat tissue to heal diabetic foot ulcers

Inclusion Criteria:

1. Age ≥ 18 years at the time of consent
2. The patient's psychophysical and legal ability to give informed consent to participate in the study,
3. Signing the informed consent document for participation in the study,
4. A confirmed diagnosis of type 1 diabetes, type 2 diabetes, LADA, MODY, or other types of diabetes, documented in accordance with current diagnostic criteria.
5. Ulcer classified as diabetic foot syndrome (DFS) of neuropathic and/or neuroischemic etiology corresponding to grade IA/IIA and IC/IIC according to the University of Texas classification (Appendix E),
6. A period of not less than 6 weeks since the onset of the ulceration,
7. Presence of a wound of 1-25 cm2 (after wound debridement),
8. Satisfactory blood supply to the wound area (assessed by transcutaneous measurement of oxygen partial pressure, if not less than 30 mmHg, or measurement of systolic arterial pressure on the posterior tibial and/or dorsal artery of the foot, which will not be less than 50 mmHg) to exclude patients who require revascularisation therapy
9. A glycated haemoglobin value (HbA1c) of no more than 11%,
10. General health status of the patient that, in the opinion of the investigator, allows participation in all study procedures,
11. Use of a form of wound relief recommended by the Investigator,
12. In the case of women of childbearing potential, agreement to use of methods of effective contraception to avoid pregnancy and/or based on the following criteria: - a woman who is incapable of having offspring (after hysterectomy or bilateral ovarian resection or after menopause, defined as a period of at least 12 months since the last menstrual period) is exempt from pregnancy testing - a woman capable of having offspring with a negative pregnancy test result prior to the first day dose of the study product and who agrees to cycle pregnancy tests according to the study protocol and to use appropriate contraception until one month after the end of the active phase of the study (up to V6), or 2 months after the last administration of the study drug. For men - fertile men who are sexually active with a partner who may become pregnant are required to use a barrier method throughout the entire duration of the study, and the partners of study participants (who are capable of bearing children) are required to use the same contraceptive methods as female study participants until Visit V6.

Exclusion Criteria:

1. Etiology of the ulcer other than diabetic foot syndrome,
2. Presence of active infection in the wound at the time of inclusion in the study,
3. Wound area \<1 cm² or \>25 cm²,
4. Patient was eligible to participate in another clinical trial in the 4 weeks preceding study eligibility.
5. Clinically significant limb ischaemia (assessed by transcutaneous measurement of oxygen partial pressure if less than 30 mmHg or measurement of systolic arterial pressure on the posterior tibial and dorsal artery of the foot which is less than 50 mmHg)
6. Presence of an active phase of Charcot joint,
7. Osteitis and/or osteomyelitis, including cases assessed using a positive probe-to-bone test,
8. Revascularisation procedure in the affected lower limb within less than 3 months prior to study inclusion or planned revascularisation procedure,
9. Chronic kidney disease with GFR \< 20 ml/min,
10. Pregnancy and lactation,
11. Allergy to thrombin,
12. Active venous thrombosis,
13. Systemic diseases in the exacerbation stage (acute or decompensated), including heart, kidney, and liver diseases,
14. Active alcoholic disease or psychoactive drug addiction,
15. Allergies to dressing materials used in the study,
16. Oral/intravenous antibiotic therapy at the time of inclusion in the study,
17. A patient undergoing immunosuppressive therapy, including systemic corticosteroid therapy (within 30 days prior to study inclusion). Topical corticosteroid therapy does not constitute an exclusion criterion.
18. Patients undergoing immunotherapy for allergic diseases (within 30 days prior to the screening visit -calculated from the last dose of such therapy) or those planning to initiate or resume such therapy during the clinical trial,
19. Active cancerous process or cancer in the last 5 years, excluding locally malignant tumors that do not involve the tissues of the foot
20. Presence of a clinically known active, uncontrolled infection, e.g., Hepatitis B, Hepatitis C, HIV, and venereal disease (syphilis),
21. Significant features of malnutrition further impairing the healing process, regardless of the cause (albumin \< 2.5 g/dL and total protein \< 5g/dL),
22. Hemoglobin concentration \< 9g/dL,
23. Serum transaminase activity (alanine and aspartate) exceeding 3x the upper limit of normal (local) .