Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01898923 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
A Phase 3 study, sponsored by Oneness Biotech Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 236
- Enrollment target
NCT01898923: Completed Phase 3 study, sponsored by Oneness Biotech Co..
NCT01898923 is a Phase 3 study that has completed, run by Oneness Biotech Co.. The registered enrollment target is 236 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01898923, a Phase 3 study, has completed, sponsored by Oneness Biotech Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 236 participants
- Enrollment target
Study 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.
Primary Outcome
The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment. For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.
Interventions
- DRUG ON101 Cream
- OTHER Aquacel® Hydrofiber® dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2012-11-23 |
| Est. Completion | 2020-05-11 |
| Phase | Phase 3 |
What the finished NCT01898923 record still lists
NCT01898923 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which ON101 Cream is the first listed.
NCT01898923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01898923 about?
NCT01898923 is a clinical study titled "Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers". 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 ...
What is the current status of trial NCT01898923?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2012-11-23. Estimated completion is 2020-05-11.
What interventions are being tested in trial NCT01898923?
The interventions under investigation include: ON101 Cream (DRUG), Aquacel® Hydrofiber® dressing (OTHER).
Who is sponsoring clinical trial NCT01898923?
This trial is sponsored by Oneness Biotech Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01898923's enrollment target sits among peer trials
236 1294th of 2000 higher than 705 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04995341 · 236 participants · NA
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
- NCT05822362 · 236 participants · Phase 2
CBD for Individuals at Risk for Alzheimer's Disease
- NCT06200103 · 236 participants · Phase 2
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
- NCT06494072 · 236 participants · Phase 4
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI