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

Summary

The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.

Timeline

Start

2012-11-23

Primary completion

2020-05-11

Completion

2020-05-11

Outcome

Met primary endpoint

paper The incidence of complete healing in the FAS included 74 patients (60.7%) in the ON101 group and 40 (35.1%) in the comparator group PMID 34477854 ↗

paper difference, 25.6 percentage points; odds ratio, 2.84; 95% CI, 1.66-4.84; P < .001). PMID 34477854 ↗

release “The primary endpoint, complete healing, was found in 60.7% of the ON101 group and 35.1% of the comparison group during the treatment period (p=0.0001).” onenessbio.com ↗

Publications

• Huang YY, Lin CW, Cheng NC, Cazzell SM, Chen HH, Huang KF, Tung KY, Huang HL, Lin PY, Perng CK, Shi B, Liu C, Ma Y, Cao Y, Li Y, Xue Y, Yan L, Li Q, Ning G, Chang SC. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122607. doi: 10.1001/jamanetworkopen.2021.22607.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ON101	Unknown	1.25 %	Topical

Indications

No indication recorded.