Phase 3
Completed N=236
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Source: ClinicalTrials.gov NCT01898923 ↗Enrolled (actual)
236
Serious AEs
9.8%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With Complete Ulcer Closure — 74; 40 Participants
◆ Published Evidence
Highly cited
118citations · ~24 / year
Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial.
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.
Linked Publications
-
Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.