The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

• Status: Completed
• Trial end date: 2016-09-05
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the systemic exposures of WH-1 ointment which includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers following topical application of WH-1.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oneness Biotech Co., Ltd.

Criteria

Inclusion Criteria:

1. Male or female is at least 20 years of age;

2. Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;

3. The target diabetic foot ulcer must have the following characteristics:

1. ≤ Grade 2 per Wagner Ulcer Classification System;

2. Lower limbs;

3. No-infected;

4. A cross-sectional area of between 1 and 25 cm2 post-debridement;

4. If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;

5. Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.

Exclusion Criteria:

1. Acute Charcot' s neuroarthropathy as determined by clinical and/or radiographic examination;

2. Poor nutritional status defined as an albumin < 2.5 g/dL;

3. AST and/or ALT > 3X of the normal upper limit;

4. Clearance of Creatinine (Ccr) < 30 ml/min;

5. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;

6. 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

7. Subjects who have received an experimental agent within 30 days, prior to enroll.

8. Subjects who have received WH-1 ointment within 30 days, prior to enroll.

9. Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.

10. Judged by the investigator not to be suitable for the study for any other reason.