Trials / Completed
CompletedNCT01693133
Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- MiMedx Group, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Standard of Care: Moist Wound Therapy and Offloading | Standard of Care: Moist Wound Therapy and Offloading |
| OTHER | EpiFix plus Standard of Care | Weekly application of EpiFix and Standard of Care |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2012-09-26
- Last updated
- 2018-09-24
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01693133. Inclusion in this directory is not an endorsement.