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Evaluate the Safety and Efficacy of RegenKit Autologous PRP Gel for the Treatment of Diabetic Foot Ulcer

Diabetic Foot Ulcers Clinical Trial

Official title:
Randomized, Placebo-controlled, Blind-assessor Study to Evaluate the Safety and Efficacy of Autologous Platelet Rich Plasma Gel Prepared With the RegenKit-BCT Plus Family of Kits for the Treatment of Diabetic Foot Ulcer

Clinical Trial Summary

Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).

Clinical Trial Description

Evaluate the safety and efficacy of RegenKit autologous PRP Gel for the treatment of diabetic foot ulcer is a randomized, placebo controlled, blind-assessor study. One hundred and seventy four patients will be treated, 87 patients receiving treatment arm and 87 patients receiving placebo. The primary endpoint is to evaluate proportion of patients with complete wound closure at week 16 when treated with autologous platelet rich plasma gel compared to the proportion of control (saline gel) treated patients with complete wound closure at the same time-point. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02402374
Study type Interventional
Source Regen Lab SA
Contact
Status Enrolling by invitation
Phase N/A
Start date April 12, 2018
Completion date December 30, 2020
View Details
See also
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