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Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

NCT04962139 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Diabetic Foot Ulcers

Interventions

DRUG

ON101 Cream

Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

OTHER

Vehicle Cream

ON101 Cream Placebo

Sponsors & Collaborators

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shyi-Gen Chen · Oneness Biotech Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2022-11-01
Completion
2022-11-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04962139 on ClinicalTrials.gov