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Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers

NCT02861560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-08-24

No results posted yet for this study

Summary

A prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure ulcers

Conditions

  • Pressure Ulcer

Interventions

OTHER

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

  • Donald Fetterolf, MD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-05-31
Completion
2018-05-31

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 NCT02861560 on ClinicalTrials.gov