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NCT01060670 · ClinicalTrials.gov registry record · NA
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
A NA study, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 545
- Enrollment target
NCT01060670: Completed NA study, sponsored by Integra LifeSciences Corporation.
NCT01060670 is a NA study that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 545 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01060670, a NA study, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 545 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.
Primary Outcome
100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.
Interventions
- DEVICE Integra® Dermal Regeneration Template
- OTHER Conventional Wound Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-06 |
| Phase | NA |
What the finished NCT01060670 record still lists
NCT01060670 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Integra® Dermal Regeneration Template is the first listed.
NCT01060670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01060670 about?
NCT01060670 is a clinical study titled "A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers". The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.
What is the current status of trial NCT01060670?
This trial is currently completed. It is a NA study. The enrollment target is 545 participants. The study started on 2010-04. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01060670?
The interventions under investigation include: Integra® Dermal Regeneration Template (DEVICE), Conventional Wound Therapy (OTHER).
Who is sponsoring clinical trial NCT01060670?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01060670's enrollment target sits among peer trials
545 186th of 2000 higher than 1,815 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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