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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Drug: ON101 Cream
* Other: Aquacel® Hydrofiber® dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Has signed a written informed consent prior to the first study evaluation; Male or female is at least 20 and < 80 years of age; Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization; An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization; The target ulcer must have the following characteristics: Grade 1 or 2 per Wagner Ulcer Classification System; No higher than the ankle; No active infected; A cross-sectional area of between 1 and 25 cm2 post-debridement; Present for at least 4 weeks before randomization; If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit; Able and willing to attend the scheduled visits and comply with study procedures. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ON101 Cream<br>ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. | Drug: ON101 Cream<br> <br> * Other names: WH-1;|
| Other: Aquacel® Hydrofiber® dressing<br>Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. | Other: Aquacel® Hydrofiber® dressing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time of Healing Rate | Time to complete ulcer healing, The time of the original healing will be taken as the time to healing. | 16 weeks | 
| Change in Ulcer Area | Percentage change in ulcer surface area from baseline | 16 weeks | 
| Percentage of Participants With a 50% Reduction of Ulcer Surface Area | Percentage of subjects with a 50% reduction of ulcer surface area | 16 weeks | 
| Incidence of Infection of the Target Ulcer | Incidence of infection of the target ulcer | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WH-1,Diabetic Foot,Ulcer