At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
SECONDARY dressing gauze and tape +3 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 Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers
In Brief
A Phase 3 clinical trial evaluating SECONDARY dressing gauze and tape, debridement, irrigation, and 2 other interventions for Diabetic Foot Ulcer. Completed, enrolled 120 participants across 1 site.
Detailed Summary
The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesUnited States
CollaboratorsVA Northern California Health Care System
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionDec 2017
Study CompletionApr 2018
TodayJul 2026
First PostedOct 13, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 14, 2017
Study CompletionApr 4, 2018
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 14.7 years ago
Interventions
SECONDARY dressing gauze and tapedevice
SECONDARY dressing gauze and tape
debridement, irrigationprocedure
debridement, irrigation
Dermagraftdevice
Dermagraft per company protocol
Oasisdevice
Oasis per company protocol