Clinical trial NCT02353273: The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
Official title: The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Foot
Keywords: WH-1,Diabetic Foot,Ulcer
Lead sponsor: Oneness Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-02
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)
timeFrame: Day1; Day14
Secondary outcomes:
measure: Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)
timeFrame: Day1
measure: Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)
timeFrame: Day14
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Clinical Research Division
Study officials:
affiliation: Tri-Service General Hospital
name: Kai-Min Chu
role: PRINCIPAL_INVESTIGATOR
References: