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

• Status: Completed
• Trial end date: 2020-05-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oneness Biotech Co., Ltd.
• Treatments: Carboxymethylcellulose Sodium

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.