Back to resultsA Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
Primary Purpose
Diabetic Foot Ulcers, Wound Care
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AmnioClear™ Human Allograft Amniotic Membrane
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers
Eligibility Criteria
Inclusion Criteria:
- Stable Type I or II diabetes mellitus
- At least one chronic diabetic ulcer
- Full-thickness ulcer size from 1-8 cm2.
Exclusion Criteria:
- Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
- Bleeding disorders
- Ulcer with muscle, tendon, capsule or bone involvement
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
AmnioClear™
Standard of Care
Arm Description
AmnioClear™ Human Allograft Amniotic Membrane
Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing)
Outcomes
Primary Outcome Measures
Reduction in Wound Size
Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02120755
Brief Title
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
Official Title
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Never Started
Study Start Date
undefined (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liventa Bioscience
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.
The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers, Wound Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AmnioClear™
Arm Type
Active Comparator
Arm Description
AmnioClear™ Human Allograft Amniotic Membrane
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing)
Intervention Type
Biological
Intervention Name(s)
AmnioClear™ Human Allograft Amniotic Membrane
Primary Outcome Measure Information:
Title
Reduction in Wound Size
Description
Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Stable Type I or II diabetes mellitus
At least one chronic diabetic ulcer
Full-thickness ulcer size from 1-8 cm2.
Exclusion Criteria:
Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
Bleeding disorders
Ulcer with muscle, tendon, capsule or bone involvement
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
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