Evaluation of the Safety and Efficacy of the Treatment of Chronic Wounds in Diabetic Foot Syndrome With the Use of Allogeneic Stem Cells Isolated From Adipose Tissue

Medical University of Warsaw1 site in 1 country46 target enrollmentJuly 1, 2019

ConditionsDiabetic Foot Ulcer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Medical University of Warsaw
Enrollment: 46
Locations: 1
Primary Endpoint: Changes in wound size
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.

Detailed Description

The product will contain an active ingredient- human allogeneic adipose-derived mesenchymal stem cells (ADSC) cells suspended in the fibrin solution applied directly onto prepared wound bed, to form thin gel layer on the wound surface.

Registry

clinicaltrials.gov

Start Date

July 1, 2019

End Date

September 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of Warsaw

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signing informed consent form.
•Above the age of 18
•Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
•Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
•Blood level of glycated haemoglobin (HbA1c) \<=11%
•Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (\>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\>=50 mmHg) of the affected limb.
•General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures.

Exclusion Criteria

•Lack of patient's cooperation
•Wound etiology other than diabetic foot syndrome
•Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (\<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\<50 mmHg)
•Active wound infection, which would require the treatment with antibiotics
•Known allergy to ingredients of study product (thrombin, penicillin).
•Active venous thromboembolism
•Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study
•Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study

Outcomes

Primary Outcomes

Changes in wound size

Time Frame: 8 weeks

The comparison of the time required for the 50% reduction of initial wound size between patients in both study arms. The wound size changes will be assessed using digital 3D wound imaging medical device with image processing software, according to the following rules: * for wounds deeper than 0.5 cm - measurement of wound volume, or * for shallow wounds (less than 0.5 cm depth) - measurement of wound surface.