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Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers

NCT02209051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-12-02

No results posted yet for this study

Summary

The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers

Conditions

  • Diabetic Foot Ulcers

Interventions

OTHER

AMNIOEXCEL

Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.

OTHER

Standard of Care, Diabetic Foot Ulcers

Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-08-31
Completion
2015-08-31

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 NCT02209051 on ClinicalTrials.gov