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

This trial is designed as an open label, non-comparative study to evaluate the pharmacokinetic profiles of salvigenin and asiaticoside A in subjects who received the treatment of WH-1 ointment for diabetic foot ulcers. A total of 12 subjects will be completed in study. Each subject will be applied the one dose of WH-1 ointment on Day 1 following with the blood sampling collection, then twice a day of WH-1 application from Day 2 to Day 13, and another blood sampling collection scheduled on Day 14 after one dose application.

Inclusion criteria

• Male or female is at least 20 years of age;
• Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;
• The target diabetic foot ulcer must have the following characteristics:

• ≤ Grade 2 per Wagner Ulcer Classification System;
• Lower limbs;
• No-infected;
• A cross-sectional area of between 1 and 25 cm2 post-debridement;
• If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;
• Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.

Exclusion criteria

• Acute Charcot' s neuroarthropathy as determined by clinical and/or radiographic examination;
• Poor nutritional status defined as an albumin < 2.5 g/dL;
• AST and/or ALT > 3X of the normal upper limit;
• Clearance of Creatinine (Ccr) < 30 ml/min;
• Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;
• 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
• Subjects who have received an experimental agent within 30 days, prior to enroll.
• Subjects who have received WH-1 ointment within 30 days, prior to enroll.
• Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.
• Judged by the investigator not to be suitable for the study for any other reason.