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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353273
• Other study ID #: ON101CLPK01
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2015
• Last updated: March 26, 2018
• Start date: July 22, 2015
• Est. completion date: September 5, 2016

Study information

• Verified date: March 2018
• Source: Oneness Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 5, 2016
• Est. primary completion date: July 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	Clinical Research Division	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Oneness Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-8, AUC0-t, Cmax)(Cmax,ss, AUC0-t)	AUC0-8, AUC0-t, Cmax: Area under the concentration-time curve from time 0 to infinity (AUC0-8); Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t); Maximum observed level (Cmax); Cmax,ss, AUC0-t: Maximum observed plasma concentration at steady state (Cmax,ss); Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-t).	Day1; Day14
Secondary	Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)	Time to peak concentration (Tmax); Mean residence time (MRT); Elimination half-life (T1/2); Apparent volume of distribution (Vd/F); Apparent clearance (CL/F)	Day1
Secondary	Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)	Time to peak concentration at steady state (Tmax,ss)	Day14