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NCT03547635 · ClinicalTrials.gov registry record · NA
AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
A NA study of Diabetic Foot Ulcer, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 116
- Enrollment target
- 7
- Study locations
NCT03547635: Completed NA study of Diabetic Foot Ulcer, sponsored by Integra LifeSciences Corporation.
NCT03547635 is a NA study of Diabetic Foot Ulcer that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 116 participants, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (54% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03547635, a NA study of Diabetic Foot Ulcer, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 116 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).
Primary Outcome
Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Conditions Studied
Interventions
- OTHER Standard of Care
- OTHER AMNIOEXCEL Plus Amniotic Membrane
- DEVICE A Marketed Comparator
Study Locations (7)
California
- California 1 - Fresno
- California 3 - Fresno
- California 2 - Los Angeles
Georgia
- Georgia 1 - Gainesville
Illinois
- Illinois 1 - Springfield
New Jersey
- New Jersey 1 - Toms River
Texas
- Texas 1 - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2019-02-26 |
| Phase | NA |
What the finished NCT03547635 record still lists
NCT03547635 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT03547635 lists 7 locations in 5 states (California, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT03547635 about?
NCT03547635 is a clinical study titled "AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers". This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).
What is the current status of trial NCT03547635?
This trial is currently completed. It is a NA study. The enrollment target is 116 participants. The study started on 2018-05-03. Estimated completion is 2019-02-26.
What conditions does trial NCT03547635 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT03547635?
The interventions under investigation include: Standard of Care (OTHER), AMNIOEXCEL Plus Amniotic Membrane (OTHER), A Marketed Comparator (DEVICE).
Who is sponsoring clinical trial NCT03547635?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03547635 being conducted?
This trial has 7 study locations across California, Georgia, Illinois, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03547635's enrollment target sits among peer trials
116 35th of 67 higher than 32 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
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-
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
RECRUITING · NA
-
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
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Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
RECRUITING · NA
-
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
RECRUITING · NA
-
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
RECRUITING · NA
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