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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353273
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Oneness Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 21, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE July 22, 2015
Actual Primary Completion Date July 5, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
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:
  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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
  • Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax) [ Time Frame: Day1 ]
    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)
  • Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (Cmax,ss, AUC0-τ) [ Time Frame: Day14 ]
    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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
  • Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F) [ Time Frame: 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) [ Time Frame: Day14 ]
    Time to peak concentration at steady state (Tmax,ss)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
Official Title  ICMJE The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: WH-1 ointment
WH-1 ointment(1.25%),15g ointment per tube.
Intervention: Drug: WH-1 ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 5, 2016
Actual Primary Completion Date July 5, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353273
Other Study ID Numbers  ICMJE ON101CLPK01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oneness Biotech Co., Ltd.
Study Sponsor  ICMJE Oneness Biotech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kai-Min Chu Tri-Service General Hospital
PRS Account Oneness Biotech Co., Ltd.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP