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

NCT01898923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2021-04-14

Study results available
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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.

Conditions

  • Diabetic Foot

Interventions

DRUG

ON101 Cream

OTHER

Aquacel® Hydrofiber® dressing

Sponsors & Collaborators

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Henry Chang · Oneness Biotech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-23
Primary Completion
2020-05-11
Completion
2020-05-11

Countries

  • United States
  • China
  • Taiwan

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 NCT01898923 on ClinicalTrials.gov