Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT04962139. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Phase-III Study to Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
Study identification
- NCT ID
- NCT04962139
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 26, 2021
- Primary completion
- Oct 31, 2022
- Completion
- Nov 28, 2022
- Last update posted
- Mar 12, 2025
2021 – 2022
United States locations
- U.S. sites
- 14
- U.S. states
- 5
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Oneness Investigational Site | Mesa | Arizona | 85206 | — |
| Oneness Investigational Site | Carlsbad | California | 92009 | — |
| Oneness Investigational Site | Castro Valley | California | 94546 | — |
| Oneness Investigational Site | Fresno | California | 93710 | — |
| Oneness Investigational Site | San Francisco | California | 94117 | — |
| Oneness Investigational Site | Sylmar | California | 91342 | — |
| Oneness Investigational Site | Miami | Florida | 33165 | — |
| Oneness Investigational Site | Miami Lakes | Florida | 33016 | — |
| Oneness Investigational Site | North Miami Beach | Florida | 33321 | — |
| Oneness Investigational Site | Mount Prospect | Illinois | 60056 | — |
| Oneness Investigational Site | O'Fallon | Illinois | 62269 | — |
| Oneness Investigational Site | Springfield | Illinois | 62704 | — |
| Oneness Investigational Site | Dallas | Texas | 75251 | — |
| Oneness Investigational Site | McAllen | Texas | 78501 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04962139, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04962139 live on ClinicalTrials.gov.