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Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU).
In this study, allogenic, defibrinated platelet rich plasma lysate will be used as a direct injection into the periphery of diabetic chronic foot ulcers which have not healed using standard of care. Investigators anticipate a significant response in treated individuals measured by the percentage of skin restoration achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Lysate | Active Comparator | Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3). |
|
| Platelet Poor Plasma | Placebo Comparator | Patients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Lysate | Biological | Direct injection of allogenic Platelet Lysate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection | Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of allogenic Platelet Lysate injection by clinical examination | To determine short term speed and effectiveness of allogeneic, platelet rich plasma lysate on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the diameter of ulcers. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanan Jafar, PhD | Contact | 00962798871087 | hanan.jafar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abdallah Awidi, MD | Cell Therapy Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cell Therapy Center | Recruiting | Amman | 11942 | Jordan |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Platelet Poor Plasma |
| Biological |
Direct injection of allogenic Platelet Poor Plasma |
|
| 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 |