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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Drug: WH-1 ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 115
    • Clinical Research Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WH-1 ointment; WH-1 ointment(1.25%),15g ointment per tube.	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.; Other Names: No other intervention drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)	AUC0-∞, AUC0-t, Cmax: Area under the concentration-time curve from time 0 to infinity (AUC0-∞); Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t); Maximum observed level (Cmax) Cmax,ss, AUC0-τ: 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-τ).	Day1; Day14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)	Time to peak concentration at steady state (Tmax,ss)	Day14

Collaborators and Investigators

• Sponsor: Oneness Biotech Co., Ltd.
• Investigators: Principal Investigator: Kai-Min Chu, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2015
• Primary Completion (Actual): July 5, 2016
• Study Completion (Actual): September 5, 2016

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: WH-1,Diabetic Foot,Ulcer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: ON101CLPK01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No