Evaluation of the safety and efficacy of the treatment of chronic wounds in diabetic foot syndrome with the use of autologous stem cells isolated from adipose tissue - within the project: Therapeutic potential of adipose-derived stem cells, proven in clinical trials and examined in vitro - rationale for banking of well characterized cells”

Phase 1

• Conditions: Diabetic foot ulcer; MedDRA version: 20.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-004109-15-PL
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-10
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Signing informed consent form.
2.Above the age of 18
3.Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
4.Chronic wound in the course of diabetic foot syndrome, with duration of at least 12 weeks and the wound surface not less than 2 sq. cm and not greater than 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
5.Blood glucose control - fasting not more than 180 mg% OR HbA1c not more than 10%.
6.Good tolerance of the current standard of treatment lasting at least one week before including the patient into the study
7.Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (> 20mmHg) in patients with neuropathic etiology of diabetic foot syndrome
8.In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb’s blood supply as a result of the revascularization procedure documented by X-ray or ultrasound.
9.Ankle-brachial index (ABI) = 0.8
10.No active infection of the wound and surrounding tissue verified by quantitative microbiological testing (105 bacteria per 1 g of tissue taken for testing from a wound)
11.For women of childbearing potential - a negative pregnancy test result during the screening visit and using of effective contraceptive methods during participation in the research.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Lack of patient’s cooperation
2.Ischemia of lower limbs; ankle-brachial index <0.8; significant vein component in medical patient’s history shown in the Duplex-Doppler tests made within 6 months before joining the research.
3.Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study
4.No clinical improvement after revascularization procedures performed on the vascular system of the treated limb during the last 2 weeks
5.Venous thromboembolism in the past 3 months preceding participation in the research
6.Sings of severe osteolysis and / or bone and marrow infection around wounds on the basis of the result of X-ray, CT or MRI of the feet made within 6 months before participation in the study.
7.The active inflammation phase in the course of Charcot's neuroartropathy.
8.Treatment with antibiotics, immunosuppressive therapy, including systemic steroid therapy (excluding inhaled medicines) at the time of joining the study.
9.Chronic diseases in the stage of exacerbation, not stabilized, that in the opinion of the investigator may hinder or make impossible a patient’s participation in the study and reviewed on the basis of subjective and objective examination and laboratory tests carried out during the screening visit (blood type, morphology, electrolytes, coagulation system, blood glucose, urea, creatinine, and viral tests). Test results behind laboratory standards for a specific parameter are considered as incorrect. In the case of treatment with vitamin K antagonists, normal ranges suitable for this treatment will apply.
10.Known allergic reactions to ingredients of dressing (thrombin, penicillin).
11.The diagnosis of AIDS, HBV or HCV
12.Reactive result of serological and viral tests:
HIV-1 and 2 (HIV Ag / Ab);
Hepatitis B Virus Infection, Anti-HBc;
Hepatitis C Virus Infection, Anti-HCV;
Syphilis specific tests

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Evaluation of the safety and efficacy of the therapy with autologous stem cells isolated from adipose tissue of the patient in the treatment of chronic wounds in the diabetic foot syndrome.<br> ;<br> Secondary Objective: Assessment of wound’s morphology: effusion, redness and / or swelling of the skin around the wound, presence of granular or fibrous.<br> Analysis of the expression of selected pro-angiogenic factors in the wound treated with the studied method compared to the wound treated in standard manner.<br> ;Primary end point(s): Time needed for a 50% reduction in wound size in comparison to the original volume;Timepoint(s) of evaluation of this end point: Time to first occurence.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of changes in the morphology of the wound, and expression analysis of selected proangiogenic factors in the wound treated with the tested method (AKM), relative to the wound being treated in a standard way.;Timepoint(s) of evaluation of this end point: Time to first occurence.