Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 21
- 主要终点
- Number of Participants With Complete Ulcer Closure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
ON101 Cream
ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.
干预措施: ON101 Cream (Drug)
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.
干预措施: Aquacel® Hydrofiber® dressing (Other)
结局指标
主要结局
Number of Participants With Complete Ulcer Closure
时间窗: 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.
次要结局
- Change in Ulcer Area(16 weeks)
- Percentage of Participants With a 50% Reduction of Ulcer Surface Area(16 weeks)
- The Time of Healing Rate(16 weeks)
- Incidence of Infection of the Target Ulcer(16 weeks)