ON101 Cream for Foot Ulcer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called ON101 to determine its effectiveness in healing chronic foot ulcers in people with diabetes. The goal is to compare the cream's efficacy to a placebo cream, both used alongside standard ulcer care for up to 20 weeks. People with diabetes who have had foot ulcers for 6 weeks to a year and can still walk on the non-affected foot might be suitable for this study. Participants will apply the cream to their ulcers twice daily and follow care routines to keep the wound clean and well-managed. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ON101 Cream is generally safe for use. A previous report mentioned that the benefits of using Fespixon cream, which is the same as ON101, outweigh the risks. Another study supported the safety of ON101 Cream and noted its ability to aid wound healing. The Taiwan Food and Drug Administration also found the cream safe for treating certain diabetic foot ulcers. Overall, these findings suggest that ON101 Cream is well-tolerated with few safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ON101 Cream because it offers a novel approach to treating chronic diabetic foot ulcers. Unlike standard treatments that primarily focus on wound care and infection management, ON101 Cream is designed to actively promote wound healing by enhancing tissue regeneration. This cream contains a unique combination of ingredients that work together to accelerate the healing process, potentially offering faster and more effective results than existing options. Moreover, the cream is applied directly to the ulcer, making it a straightforward addition to the standard care routine.

What evidence suggests that ON101 Cream might be an effective treatment for Target Ulcer?

Research has shown that ON101 Cream, which participants in this trial may receive, can help heal chronic diabetic foot ulcers. One study found that people using ON101 Cream experienced significantly better healing than those using regular wound dressings. In everyday use, patients observed promising reductions in ulcer size, with some experiencing up to a 107% decrease with continued use. The cream aids certain cells, called macrophages, which are crucial for wound healing. These findings suggest that ON101 Cream can close chronic diabetic foot ulcers more effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

Shyi-Gen Chen

Principal Investigator

Oneness Biotech Co., Ltd.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ON101 Cream
• Vehicle Cream

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12232343/

Cost‐effectiveness of ON101 with general wound care for ...

Economic evaluations considering costs and outcomes of diabetic foot ulcer infections: a systematic review. ... Cost‐effectiveness analysis for ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S002561962500076X

Real-World Effectiveness and Dose-Response of ON101 ...

The dose-response analysis results suggest 25%, 107%, 33%, and 19% decreases in the ulcer size per additional ON101 tube use for all study ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01898923

Evaluate the Efficacy and Safety of ON101 Cream for ...

Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers. ClinicalTrials.gov ID NCT01898923. Sponsor Oneness ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2783718

Effect of a Novel Macrophage-Regulating Drug on Wound ...

Topical application of ON101 with gauze immediately after debridement demonstrated significant healing efficacy compared with an absorbent dressing in all ...

5.

mayoclinicproceedings.org

mayoclinicproceedings.org/article/S0025-6196(25)00076-X/abstract

Real-World Effectiveness and Dose-Response of ON101 ...

Promising healing outcomes following ON101 therapy at lower doses among real-world patients with DFU are corroborated, with a potential ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04962139

NCT04962139 | Evaluate the Safety and Efficacy of ON101 ...

A randomized, double-blind, parallel-group, vehicle-controlled, Phase-III study to evaluate the safety and efficacy of ON101 cream for the treatment of chronic ...

7.

hsa.gov.sg

hsa.gov.sg/docs/default-source/hprg-tpb/summary-reports/fespixon-cream-summary-report.pdf?sfvrsn=debaa682_4

fespixon-cream-summary-report.pdf

Based on the review of quality, safety and efficacy data, the benefits of Fespixon cream have been demonstrated to outweigh the risks of the ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8417758/

Effect of a Novel Macrophage-Regulating Drug on Wound ...

The topical use of ON101 is supported with a safety profile from the manufacturer and has clear therapeutic potential in promoting wound ...

9.

onenessbio.com

onenessbio.com/en/medicine_detail2_0.htm

ON101

Phase 3 multicenter randomized clinical trials (MRCT) was completed. ON101 has been demonstrated with 60.7% vs 35.1% (p=0.0001) in complete healing rate in 16- ...

10.

fda.gov.tw

fda.gov.tw/tc/includes/GetFile.ashx?mid=189&id=39745&t=s

Taiwan Food and Drug Administration Assessment Report

Based on the submitted data, the safety of ON101 for the treatment of Wagner Grade 1 or 2 DM foot was acceptable. Considering the extremely low ...