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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control.
Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.
Medical University of Warsaw, Department of Diabetology and Internal Diseases
Warsaw, Poland
Changes in wound size
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.
Time frame: 8 weeks
Changes in wound morphology
Clinical assessment of wound morphology (and its changes during the treatment) in each treated patient, as well, as between patients in both study arms, expressed as: * the amount (1) and features (2) of wound exudate, * the presence of redness (3) and/or edema (4) in the wound surrounding skin, * the presence of granular tissue and fibrin (5) or epithelium (6) in the wound bed. The listed parameters will be assessed using simplified questionnaire adopted from Bates-Jensen Wound Assessment Tool (positions 7-13 from B-JWAT). Each of 6 abovementioned features will be assessed semiquantitatively using 1-5 points scale, (with "1" for a best state, and "5" for a worst state). The sum of points allocated to each parameter will be recorded as the wound score and used for further analysis. The healthy skin/healed wound should receive 6 points, whereas active wound, with exudate and inflammation will receive 30 points (the lower = the better / the higher = the worse).
Time frame: 8 weeks
Changes in pro-angiogenic factors expression
Evaluation of the expression (and its changes during the treatment) of selected pro-angiogenic factors, measured in wound biopsies. The changes will be analyzed for each tested individual separately, and compared between both study arms.
Time frame: 8 weeks
Changes in wound-associated pain
Evaluation of the wound-associated pain, assessed by the patient using visual analogue scale. The minimum value is 0 and means "no pain" and the maximum value is 10 and means "the worst possible pain". The lower value the better outcome. The changes will be analyzed for each tested individual separately, and compared between both study arms.
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Time frame: 8 weeks
Changes in the quality of life
Evaluation of the patient's quality of life, assessed by the dedicated QoL questionnaire. The QoL questionnaire consists of 10 questions. Each question is scored 1 to 5. The minimum score is 10 and it means "the best possible state of health", and the maximum score is 50, which means ,,the worst possible state of health". The changes will be analyzed for each tested individual separately, and compared between both study arms.
Time frame: 8 weeks
Record of adverse events
Evaluation of the safety of ADSC application, assessed by the occurrence of any adverse events.
Time frame: 8 weeks