Trials / Completed
CompletedNCT03529578
A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.
A Case Series to Investigate the Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Pressure Ulcers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- MiMedx Group, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2017-06-06
- Primary completion
- 2019-06-01
- Completion
- 2019-06-01
- First posted
- 2018-05-18
- Last updated
- 2020-11-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03529578. Inclusion in this directory is not an endorsement.