The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT02353273|
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : March 29, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot||Drug: WH-1 ointment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers|
|Actual Study Start Date :||July 22, 2015|
|Actual Primary Completion Date :||July 5, 2016|
|Actual Study Completion Date :||September 5, 2016|
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 Name: No other intervention drug
- Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ) [ Time Frame: Day1; Day14 ]
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)
- 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).
- Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F) [ Time Frame: Day1 ]
- Time to peak concentration (Tmax)
- Mean residence time (MRT)
- Elimination half-life (T1/2)
- Apparent volume of distribution (Vd/F)
- Apparent clearance (CL/F)
- Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss) [ Time Frame: Day14 ]Time to peak concentration at steady state (Tmax,ss)
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|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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;
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353273
|Clinical Research Division|
|Taipei, Taiwan, 115|
|Principal Investigator:||Kai-Min Chu||Tri-Service General Hospital|
|Responsible Party:||Oneness Biotech Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||February 2, 2015 Key Record Dates|
|Last Update Posted:||March 29, 2018|
|Last Verified:||March 2018|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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