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

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Oneness Biotech Co., Ltd.

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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)

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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

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Treatment Details

Interventions

ON101 Cream (Topical Agent)
Vehicle Cream (Procedure)

Participant Groups

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.