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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03547635
The ClinicalTrials.gov registry entry for NCT03547635 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (54% lower). The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 5 distinct geographic areas - top geographies include 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
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-
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-
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.