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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.

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Drug: WH-1 ointment Phase 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Taiwan
Clinical Research Division
Taipei, Taiwan, 115
Sponsors and Collaborators
Oneness Biotech Co., Ltd.
Investigators
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Principal Investigator: Kai-Min Chu Tri-Service General Hospital
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Responsible Party: Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02353273    
Other Study ID Numbers: ON101CLPK01
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oneness Biotech Co., Ltd.:
WH-1,Diabetic Foot,Ulcer
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases