Diabetic Foot
Conditions
Keywords
WH-1,Diabetic Foot,Ulcer
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.
Interventions
DRUGWH-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.
Sponsors
Oneness Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ) | Day1; Day14 | AUC0-∞, AUC0-t, Cmax: 1. Area under the concentration-time curve from time 0 to infinity (AUC0-∞) 2. Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t) 3. Maximum observed level (Cmax) Cmax,ss, AUC0-τ: 1. Maximum observed plasma concentration at steady state (Cmax,ss) 2. Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-τ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F) | Day1 | 1. Time to peak concentration (Tmax) 2. Mean residence time (MRT) 3. Elimination half-life (T1/2) 4. Apparent volume of distribution (Vd/F) 5. Apparent clearance (CL/F) |
| Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss) | Day14 | Time to peak concentration at steady state (Tmax,ss) |
Countries
Taiwan
Outcome results
None listed