Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
- Conditions
- Diabetic Foot
- Interventions
- Other: Aquacel® Hydrofiber® dressing
- Registration Number
- NCT01898923
- Lead Sponsor
- Oneness Biotech Co., Ltd.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
Not provided
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
- Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
- Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization;
- Poor nutritional status defined as an albumin < 2.5 g/dL;
- Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit;
- Serum Creatinine >2 x the normal upper limit;
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization;
- Use of any investigational drug or therapy within the 4 weeks prior to randomization;
- A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance;
- Judged by the investigator not to be suitable for the study for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ON101 Cream ON101 Cream ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. Aquacel® Hydrofiber® dressing Aquacel® Hydrofiber® dressing Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.
- Primary Outcome Measures
Name Time Method Number of Participants With Complete Ulcer Closure 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.
- Secondary Outcome Measures
Name Time Method Change in Ulcer Area 16 weeks Percentage change in ulcer surface area from baseline
Percentage of Participants With a 50% Reduction of Ulcer Surface Area 16 weeks Percentage of subjects with a 50% reduction of ulcer surface area
The Time of Healing Rate 16 weeks Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.
Incidence of Infection of the Target Ulcer 16 weeks Incidence of infection of the target ulcer
Trial Locations
- Locations (21)
Chi Mei Medical Center-Yongkang
🇨🇳Tainan City, Taiwan
Chang Gung Medical Hospital_Linkou
🇨🇳Taoyuan City, Taiwan
China Medical University Hospital-Beigang Branch
🇨🇳Yunlin, Taiwan
Chang Gung Medical Hospital_Kaohsiung
🇨🇳Kaohsiung, Taiwan
Buddhist Tzu Chi Medical Hospital
🇨🇳New Taipei City, Taiwan
MacKay Memorial Hospital-Tamsui Branch
🇨🇳New Taipei City, Taiwan
MacKay Memorial Hospital-Taipei Branch
🇨🇳Taipei City, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
The First Affiliated Hospital of Henan Science & Technology University
🇨🇳Luoyang, Henan, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai TCM-Interated Hospital
🇨🇳Shanghai, Shanghai, China
Limb Preservation Platform, Inc.
🇺🇸Fresno, California, United States
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Nanfang Hospital of Southern Medical University
🇨🇳Guanzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guanzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
China Medical University Hospital
🇨🇳Taichung City, Taiwan
Tri-Service General Hospital
🇨🇳Taipei City, Taiwan