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A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers

NCT02312596 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-13

No results posted yet for this study

Summary

A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

PRP Concepts Fibrin Bio-Matrix

Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice

OTHER

Usual and Customary Practice

Usual and customary care for non-healing wounds

Sponsors & Collaborators

  • PRP Concepts, LLC

    lead INDUSTRY

Principal Investigators

  • Damon Keeley · PRP Concepts, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-31
Completion
2021-12-31
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 NCT02312596 on ClinicalTrials.gov