A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT01060670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01060670
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 545 participants
Conditions and interventions
Conditions
Interventions
Device · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2010 (Type not available)
- Primary completion
- Jun 2014 (Actual)
- Completion
- Jun 2014 (Actual)
- Last update posted
- Sep 22, 2016
2010 – 2014
United States locations
- U.S. sites
- 32
- U.S. states
- 15
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Costal Clinical Research | Mobile | Alabama | 36608 | — |
| Stockdale Podiatry Group | Bakersfield | California | 93309 | — |
| Center for Clinical Research | Castro Valley | California | 94546 | — |
| Diabetic Foot and Wound Treatment Center | El Centro | California | 92243 | — |
| Sacramento Foot and Ankle Center | Fair Oaks | California | 95628 | — |
| Advanced Foot Care and Clinical Research Center | Fresno | California | 93722 | — |
| Center for Clinical Research | Fresno | California | 94115 | — |
| California School of Podiatry Medicine at Samuel Merritt University | Oakland | California | 94609 | — |
| Northern California Foot and Ankle Center | Santa Rosa | California | 95403 | — |
| Bay Pines VA Healthcare System | Bay Pines | Florida | 33744 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33136 | — |
| South Florida Wound Care Group | Tamarac | Florida | 33321 | — |
| C/O Center for Wound Care | Wellington | Florida | 33414 | — |
| Village Podiatry Center | Atlanta | Georgia | 30308 | — |
| Idaho Falls Infectious Diseases, PLLC | Idaho Falls | Idaho | 83404 | — |
| Springfield Clinic | Springfield | Illinois | 62703 | — |
| Infectious Disease of Indiana | Indianapolis | Indiana | 46260 | — |
| Benchmark Research | Metarie | Louisiana | 70006 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Cambridge Health Alliance | Cambridge | Massachusetts | 02139 | — |
| Montana Medical Research | Missoula | Montana | 59808 | — |
| Advanced Foot and Ankle Center | Las Vegas | Nevada | 89119 | — |
| Excelsior Foundation of WNY | Amherst | New York | 14226 | — |
| Private Practice | East Setauket | New York | 11733 | — |
| Columbia University Medical Center | New York | New York | 10034 | — |
| Penn North Center For Advanced Wound Care | Erie | Pennsylvania | 16544 | — |
| Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | — |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Limb Salvage Center | Dallas | Texas | 75231 | — |
| Department of Plastic Surgery | Dallas | Texas | 75390 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Foot and Ankle Institute | St. George | Utah | 84770 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01060670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2016 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01060670 live on ClinicalTrials.gov.