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GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

NCT02675855 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2017-07-17

No results posted yet for this study

Summary

The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.

Conditions

  • Foot Ulcer, Diabetic

Interventions

OTHER

GrafixPRIME®

Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

PROCEDURE

Dressing Application

Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

DEVICE

Off-loading (walking boot)

Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study

Sponsors & Collaborators

  • Osiris Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sharron McCulloch · Director, Clinical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-07-31
Completion
2017-07-31

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 NCT02675855 on ClinicalTrials.gov