Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 267976/13/NCBR/2015 | Other Grant/Funding Number | The National Center for Research and Development, Poland | |
| 2016-004109-15 | EudraCT Number | ||
| PL008125 | Other Identifier | EU tissue establishment code | |
| Z4217 | Other Identifier | ISBT128 (Facility Identification Number) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Polish Stem Cells Bank S.A. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic ADSC cells in fibrin solution | Experimental | Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface. |
|
| Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface. | Active Comparator | Application of fibrin gel to cover wound surface. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of allogeneic ADSC stem cells in fibrin gel | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Beata Mrozikiewicz-Rakowska, . Assoc.Prof. | Medical University of Warsaw, Department of Diabetology and Internal Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw, Department of Diabetology and Internal Diseases | Warsaw | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard care in diabetic foot ulcer | Procedure | Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control. |
|
| 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. | 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. | 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. | 8 weeks |
| Record of adverse events | Evaluation of the safety of ADSC application, assessed by the occurrence of any adverse events. | 8 weeks |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005534 | Foot Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided