Phase 3
N=236
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Diabetic Foot
Bottom Line
View on ClinicalTrials.gov: NCT01898923 ↗Enrolled (actual)
236
Serious AEs
9.8%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Complete Ulcer Closure — 74; 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ON101 Cream (Drug); Aquacel® Hydrofiber® dressing (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Oneness Biotech Co., Ltd.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Ulcer Closure |
74; 40 | — |
| SECONDARY The Time of Healing Rate |
14; NA | — |
| SECONDARY Change in Ulcer Area |
-78; -78; -36; -38 | — |
| SECONDARY Percentage of Participants With a 50% Reduction of Ulcer Surface Area |
101; 98 | — |
| SECONDARY Incidence of Infection of the Target Ulcer |
6; 7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Has signed a written informed consent prior to the first study evaluation;
- Male or female is at least 20 and 3 x the normal upper limit;
- Serum Creatinine >2 x the normal upper limit;
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization;
- Use of any investigational drug or therapy within the 4 weeks prior to randomization;
- A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance;
- Judged by the investigator not to be suitable for the study for any other reason.
Data sourced from ClinicalTrials.gov (NCT01898923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.