Clinical Trial: Evaluate the Efficacy and Safety of WH-1 Ointment for the Treatment of Chronic Diabetic Foot Ulcers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Controlled Study to Evaluate the Efficacy and Safety of WH-1 Ointment for the Treatment of Chronic Diabetic Foot Ulcers

Brief 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 Summary:

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.


Sponsor: Oneness Biotech Co., Ltd.

Current Primary Outcome: The incidence of complete ulcer closure [ Time Frame: 16 weeks ]

The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment.

For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The time of healing rate [ Time Frame: 16 weeks ]
    Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.
  • change in ulcer area [ Time Frame: 16 weeks ]
    Percentage change in ulcer surface area from baseline
  • 50% reduction in ulcer area [ Time Frame: 16 weeks ]
    Percentage of subjects with a 50% reduction of ulcer surface area
  • Incidence of infection of the target ulcer [ Time Frame: 16 weeks ]
    Incidence of infection of the target ulcer


Original Secondary Outcome: Same as current

Information By: Oneness Biotech Co., Ltd.

Dates:
Date Received: July 8, 2013
Date Started: September 2012
Date Completion: September 2018
Last Updated: January 25, 2017
Last Verified: January 2017