Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer
Intervention: ON101 Cream; Aquacel® Hydrofiber® dressing
Intervention MeSH terms: Carboxymethylcellulose Sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 236.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: WH-1,Diabetic Foot,Ulcer

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.
    

Eligibility criteria:

        Inclusion Criteria

          1. Has signed a written informed consent prior to the first study evaluation;

          2. Male or female is at least 20 and < 80 years of age;

          3. Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or
             within three months prior to randomization;

          4. An ankle brachial index on the target limb at least 0.8 measured during screening or
             within three months prior to randomization;

          5. 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;

          6. If female and of childbearing potential has a negative pregnancy test and is not
             breastfeeding at screening visit;

          7. Able and willing to attend the scheduled visits and comply with study procedures.

        Exclusion Criteria:

          1. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;

          2. Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic
             examination;

          3. Has undergone revascularization procedure aimed at increasing blood flow in the
             treatment target limb < 4 weeks prior to randomization;

          4. Poor nutritional status defined as an albumin < 2.5 g/dL;

          5. Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x
             the normal upper limit;

          6. Serum Creatinine >2 x the normal upper limit;

          7. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic
             corticosteroids less than 4 weeks before randomization;

          8. Use of any investigational drug or therapy within the 4 weeks prior to randomization;

          9. 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;

         10. Judged by the investigator not to be suitable for the study for any other reason.