← Back to Search

Topical Agent

ON101 Cream for Foot Ulcer

Phase 3
Recruiting
Research Sponsored by Oneness Biotech Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20-week treatment phase
Awards & highlights

Summary

This trial is testing whether a new treatment can help people with open wounds heal. The study will last 20 weeks, and the primary measure of success is whether the wound has completely closed.

Eligible Conditions
  • Chronic Diabetic Foot Ulcers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20-week treatment phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20-week treatment phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects with complete closure of Target Ulcer
Secondary outcome measures
The proportion of patients with Target Ulcer recurrence
Time to complete closure of Target Ulcer

Side effects data

From 2020 Phase 3 trial • 236 Patients • NCT01898923
2%
Eczema
2%
Hyperuricaemia
2%
Cellulitis
2%
Abscess limb
1%
Erythema
1%
Cerebral arteriosclerosis
1%
Hydronephrosis
1%
Osteomyelitis
1%
Rash
1%
Cerebrovascular accident
1%
Ischaemic cerebral infarction
1%
Chronic obstructive pulmonary disease
1%
Appendicitis
1%
Localised infection
1%
Necrotising fasciitis
1%
Urinary tract infection
1%
Hypokalaemia
1%
Intervertebral disc protrusion
1%
Soft tissue disorder
1%
Cardiac failure
1%
Hypoglycaemia
1%
Acute myocardial infarction
1%
Loss of consciousness
1%
Dermatitis contact
1%
Pulmonary oedema
1%
Diabetic foot
1%
Peripheral swelling
1%
Staphylococcal infection
1%
Wound complication
1%
Weight increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
ON101 Cream
Aquacel® Hydrofiber® Dressing

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ON101 Cream plus Standard of CareExperimental Treatment1 Intervention
ON101 cream will be applied twice daily for up to 20 weeks to the Target Ulcer. The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary.
Group II: Vehicle Cream plus Standard of CarePlacebo Group1 Intervention
Vehicle cream will be applied twice daily for up to 20 weeks to the Target Ulcer. The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ON101 Cream
2012
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

Oneness Biotech Co., Ltd.Lead Sponsor
19 Previous Clinical Trials
1,119 Total Patients Enrolled
7 Trials studying Foot Ulcer
486 Patients Enrolled for Foot Ulcer
Shan-Ney HuangStudy ChairOneness Biotech Co., Ltd.
Shyi-Gen ChenStudy DirectorOneness Biotech Co., Ltd.
~53 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top