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Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers

NCT02989961 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-04-10

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.

Conditions

  • Diabetic Foot Ulcer

Interventions

OTHER

Resticutis

Autologous, Activated-Platelets type of Preparation

OTHER

Platelet-Poor Plasma (PPP)

A preparation of low platelet plasma obtained by a high-speed centrifugation step.

Sponsors & Collaborators

  • Hanan Jafar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-11-15
Primary Completion
2018-03-13
Completion
2019-11-30

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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 NCT02989961 on ClinicalTrials.gov