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

NCT02402374 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2020-10-08

No results posted yet for this study

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).

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

Autologous platelet rich plasma gel

PRP gel application to exuding wounds, such as leg ulcers, pressure ulcers, and diabetic foot ulcers and for the management of mechanically- or surgically-debrided wounds

DEVICE

Placebo

Placebo control arm will be receiving commercial formulations of pre-prepared saline gel.

Sponsors & Collaborators

  • RegenLab USA LLC

    collaborator INDUSTRY

  • Regen Lab SA

    lead INDUSTRY

Principal Investigators

  • Alisha Oropallo, MD · Northwell Health, Comprehensive Wound Care Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2020-10-30
Completion
2020-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02402374 on ClinicalTrials.gov