At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 236 enrolled
Drug / intervention
ON101 Cream +1 moredrug
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.
Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
In Brief
A Phase 3 clinical trial evaluating ON101 Cream and Aquacel® Hydrofiber® dressing for Diabetic Foot. Completed, enrolled 236 participants across 21 sites in 3 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot
CountriesChina, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedJul 2013
Primary CompletionMay 2020
TodayJul 2026
First PostedJul 15, 2013
Enrollment StartNov 23, 2012
Primary CompletionMay 11, 2020
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 13.0 years ago
Interventions
ON101 Creamdrug
Aquacel® Hydrofiber® dressingother