A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
|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|
|Neuropathic Diabetic Ulcer - Foot||Device: Integra® Dermal Regeneration Template Other: Conventional Wound Therapy|
|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|
|Primary Completion Date :||June 2014|
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060670
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