A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01060670|
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : September 22, 2016
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Diabetic Ulcer - Foot||Device: Integra® Dermal Regeneration Template Other: Conventional Wound Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||545 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Dermal Replacement Device
Device: INTEGRA® Dermal Regeneration Template
Device: Integra® Dermal Regeneration Template
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
Active Comparator: Moist Wound Therapy
0.9% Saline gel
Other: Conventional Wound Therapy
Conventional Wound Therapy
- Incidence of Complete Wound Closure [ Time Frame: 16 weeks ]100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.
- Incidence of Complete Wound Closure [ Time Frame: 16 weeks ]Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.
- Time to Complete Wound Closure [ Time Frame: 16 weeks ]Measures the time to complete wound closure as assessed by the Investigator.
- Time to Complete Wound Closure [ Time Frame: 16 weeks ]Time to complete wound closure, as assessed by computerized planimetry.
- Rate of Wound Closure [ Time Frame: 16 weeks ]Rate of wound closure as assessed by computerized planimetry
- Incidence of Ulcer Recurrence [ Time Frame: 12 weeks ]Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.
- Change in Short Form Health Survey (SF-36) Quality of Life Metrics [ Time Frame: Baseline and 16 weeks ]Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060670
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