The Use of Allogenic Platelet Rich Plasma for the Treatment of Diabetic Foot Ulcer
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|ClinicalTrials.gov Identifier: NCT02972528|
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Biological: Platelet Lysate Biological: Platelet Poor Plasma||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Allogeneic Defibrinated Platelet Rich Plasma Lysate for the Healing of Chronic Diabetic Foot Ulcer|
|Actual Study Start Date :||February 3, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: Platelet Lysate
Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3).
Biological: Platelet Lysate
Direct injection of allogenic Platelet Lysate
Placebo Comparator: Platelet Poor Plasma
Patients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3).
Biological: Platelet Poor Plasma
Direct injection of allogenic Platelet Poor Plasma
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection [ Time Frame: 3 months ]Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.
- Assess the efficacy of allogenic Platelet Lysate injection by clinical examination [ Time Frame: 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972528
|Contact: Hanan Jafar, PhDfirstname.lastname@example.org|
|Cell Therapy Center||Recruiting|
|Amman, Jordan, 11942|
|Contact: Abdalla Awidi, MD 0096265355000 ext 23960 email@example.com|
|Study Director:||Abdallah Awidi, MD||Cell Therapy Center|