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

Recruiting at 27 trial locations

Overseen By Jessica Ho

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Oneness Biotech Co., Ltd.

Must be taking: Diabetes drugs

Must not be taking: Immunosuppressants, Chemotherapy, Steroids, others

Disqualifiers: Osteomyelitis, Necrosis, Sepsis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it does mention that certain treatments like immunosuppressants, chemotherapy, and some therapies could interfere with wound healing and are not allowed. It's best to discuss your specific medications with the trial team.

Research Team

Shyi-Gen Chen

Principal Investigator

Oneness Biotech Co., Ltd.

Eligibility Criteria

Inclusion Criteria

Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) > 0.8 and < 1.3, and transcutaneous pressure of oxygen (TcPO2) > 30 mmHg on at least one lead.

You have 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)

Exclusion Criteria

Body mass index (BMI) > 42 kg/m2

In response to standard of care, ulcer size reduction is > 30% during the two-week run-in Screening Period (between the first Screening Visit/V0 and Baseline/V2)

Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) and X-ray findings

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ON101 cream or vehicle cream plus standard of care for up to 20 weeks

20 weeks

Regular visits for wound evaluation and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ulcer recurrence

12 weeks

Treatment Details

Interventions

• ON101 Cream
• Vehicle Cream

Participant Groups

Group I: ON101 Cream plus Standard of Care Experimental Treatment 1 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 Care Placebo Group 1 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.

Who Is Running the Clinical Trial?

Oneness Biotech Co., Ltd.

Lead Sponsor

Trials

21

Recruited

1,200+