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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
Subject is willing to use an off-loading device for the target ulcer on the plantar while ambulation for the duration of the study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20-week treatment phase
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are willing to use a special device to help relieve pressure on the bottom of your foot while walking during the study.

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%
Hydronephrosis
1%
Cerebral arteriosclerosis
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%
Erythema
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
18 Previous Clinical Trials
1,043 Total Patients Enrolled
7 Trials studying Foot Ulcer
498 Patients Enrolled for Foot Ulcer
Shan-Ney HuangStudy ChairOneness Biotech Co., Ltd.
Shyi-Gen ChenStudy DirectorOneness Biotech Co., Ltd.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does your research team plan to test the effects of this medication on people over the age of 55?

"The age range for patients that are being recruited for this clinical trial are those between 18 and 80 years old."

Answered by AI

How many different research facilities are running this trial?

"28 hospitals are running this trial currently. They are situated in cities such as McAllen, Carlsbad, and Dallas. You can limit travel if you select a location close to you."

Answered by AI

Could I potentially join this clinical research?

"This medical study is looking for 208 participants that have diabetic foot. The study has the following requirements: The subject must be aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin., The subject has a glycosylated hemoglobin, HbA1c ≦ 12%., A full-thickness ulcer of UTWCS Grade I-A or II-A, Ulcer size (area) is > 2 cm2 and ≤ 20 cm2 (post-debridement at time of randomization), There is a"

Answered by AI

Has ON101 Cream been cleared by the FDA?

"There is available data that both supports the efficacy of ON101 Cream and multiple rounds of data collected affirms its safety; as such, we have given it a score of 3."

Answered by AI

How many individuals are providing data for this scientific investigation?

"That is correct. Based on the information available on clinicaltrials.gov, this research is still looking for test subjects. The trial was first advertised on 8/10/2021, with the most recent update on 7/15/2022. They are looking for a total of 208 individuals from 28 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
ILD Research Center - Carlsbad
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am a person with spina bifida. I have no feeling in my foot & as a result I suffer with a foot ulcer. I do what I can to protect protect it but it's recurring. I would appreciate being apart of your study because my doctors can't seem to help.
PatientReceived 2+ prior treatments
~58 spots leftby Mar 2025