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Topical Agent

ON101 Cream for Foot Ulcer

Phase 3
Waitlist Available
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
Pivotal Trial

Summary

This trial is testing a treatment for ulcers to see if it can completely heal them within a few months. The effectiveness is measured by an evaluator.

Eligible Conditions
  • Foot Ulcer

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of subjects with complete closure of Target Ulcer
Secondary study objectives
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%
Weight increased
1%
Cerebral arteriosclerosis
1%
Hydronephrosis
1%
Erythema
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
ON101 Cream
Aquacel® Hydrofiber® Dressing

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
20 Previous Clinical Trials
1,239 Total Patients Enrolled
8 Trials studying Foot Ulcer
606 Patients Enrolled for Foot Ulcer
Shan-Ney HuangStudy ChairOneness Biotech Co., Ltd.
Shyi-Gen ChenStudy DirectorOneness Biotech Co., Ltd.
~49 spots leftby Nov 2025
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