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

Not Applicable

• Conditions: Diabetic Foot Ulcers
• Interventions: Device: Autologous platelet rich plasma gel; Device: Placebo

• Registration Number: NCT02402374
• Lead Sponsor: Regen Lab SA

Brief 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).

Detailed 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 Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Study Start: 2018-04-12
• Status Verified: 2019-12
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP gel	Autologous platelet rich plasma gel	Autologous platelet rich plasma gel
Placebo	Placebo	Saline gel

Primary Outcome Measures

Name	Time	Method
Proportion of patients with complete wound closure	16 weeks	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.

Trial Locations

Locations (1)

Futuro Clinical Trials; 🇺🇸 McAllen, Texas, United States