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A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.

NCT03529578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-13

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and safety of dehydrated amnion/chorion membrane (dHACM) in the treatment of patients with stage II or III pressure ulcer and decubitus ulcers

Conditions

  • Pressure Ulcer

Interventions

PROCEDURE

dHACM

Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA)

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • David Mason, MD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2019-06-01
Completion
2019-06-01

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 NCT03529578 on ClinicalTrials.gov