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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
236
Limb Preservation Platform, Inc.
Fresno, California, United States
Number of Participants With Complete Ulcer Closure
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.
Time frame: 16 weeks
The Time of Healing Rate
Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.
Time frame: 16 weeks
Change in Ulcer Area
Percentage change in ulcer surface area from baseline
Time frame: 16 weeks
Percentage of Participants With a 50% Reduction of Ulcer Surface Area
Percentage of subjects with a 50% reduction of ulcer surface area
Time frame: 16 weeks
Incidence of Infection of the Target Ulcer
Incidence of infection of the target ulcer
Time frame: 16 weeks
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guanzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangdong, China
The First Affiliated Hospital of Henan Science & Technology University
Luoyang, Henan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Shandong Provincial Hospital
Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai TCM-Interated Hospital
Shanghai, Shanghai Municipality, China
...and 11 more locations