At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 82 enrolled
Drug / intervention
Oasis +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 Randomized, Open Label Controlled Trial of OASIS® Ultra Tri-Layer Matrix Compared to Standard Care in the Healing of Diabetic Foot Ulcers
In Brief
A Phase 4 clinical trial evaluating Oasis and Standard for Diabetic Foot Ulcer. Completed, enrolled 82 participants across 16 sites.
Detailed Summary
Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartMay 2013
Primary CompletionSep 2014
TodayJul 2026
First PostedApr 18, 2013
Enrollment StartMay 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.2 years ago
Interventions
Oasisdevice
Oasis Ultra will be applied once per week for up to 12 weeks.
Standardother