MedTrace Logo

DHACM vs Other Commercially Available Treatments

NCT01921491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-11-04

No results posted yet for this study

Summary

The purpose of this study is to determine whether dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot ulcers (DFUs).

Conditions

  • Diabetic Foot Ulcer

Interventions

PROCEDURE

Dressing Application

Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.

DEVICE

Offloading

Provision of offloading cast walker or similar sponsor-approved device. May convert into "instant total contact cast" and/or add felt/foam to supplement offloading.

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles Zelen, DPM · Professional Education and Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01921491 on ClinicalTrials.gov