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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Drug: WH-1 ointment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WH-1 ointment<br>WH-1 ointment(1.25%),15g ointment per tube. | Drug: WH-1 ointment<br>* 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.<br>* Other names: No other intervention drug;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WH-1,Diabetic Foot,Ulcer