NCT01898923

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

Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects' treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit. One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DRUG	ON101 Cream
OTHER	Aquacel® Hydrofiber® dressing

Timeline

• Start date: 2012-11-23
• Primary completion: 2020-05-11
• Completion: 2020-05-11
• First posted: 2013-07-15
• Last updated: 2021-04-14
• Results posted: 2021-04-14

Locations

21 sites across 3 countries: United States, China, Taiwan