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

NCT ID: NCT02353273

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-22
• Study Completion Date: 2016-09-05

Brief 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.

Detailed Description

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.

Conditions

Diabetic Foot

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WH-1 ointment

WH-1 ointment(1.25%),15g ointment per tube.

Group Type: EXPERIMENTAL

WH-1 ointment

Intervention Type: DRUG

Each subject will be applied the one dose of WH-1 ointment on Day 1, and twice a day of WH-1 application from Day 2 to Day 13, then one dose for Day 14.

Interventions

WH-1 ointment

Each subject will be applied the one dose of WH-1 ointment on Day 1, and twice a day of WH-1 application from Day 2 to Day 13, then one dose for Day 14.

Intervention Type: DRUG

Other Intervention Names

No other intervention drug

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oneness Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai-Min Chu

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Clinical Research Division

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

ON101CLPK01

Identifier Type: -

Identifier Source: org_study_id