At a glance
ClinicalIndex Comparison RecordN/ACompleted· 545 enrolled
Drug / intervention
Integra® Dermal Regeneration Template +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Integra® Dermal Regeneration Template and Conventional Wound Therapy for Neuropathic Diabetic Ulcer - Foot. Completed, enrolled 545 participants across 33 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuropathic Diabetic Ulcer - Foot
CountriesNetherlands Antilles, United States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartApr 2010
Primary CompletionJun 2014
TodayJul 2026
First PostedFeb 2, 2010
Enrollment StartApr 1, 2010
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.4 years ago
Interventions
Integra® Dermal Regeneration Templatedevice
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
Conventional Wound Therapyother
Conventional Wound Therapy