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CompletedNCT02353273Updated Mar 29, 2018

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

A Phase 1 interventional study of WH-1 ointment in Diabetic Foot, sponsored by Oneness Biotech Co., Ltd.. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Oneness Biotech Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Foot

Keywords

  • WH-1,Diabetic Foot,Ulcer
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Oneness Biotech Co., Ltd. is the lead sponsor of 20 studies on the registry; 4 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    WH-1 ointment

    WH-1 ointment(1.25%),15g ointment per tube.

    Drug: WH-1 ointment

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.

    Also known as: No other intervention drug

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)

    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).

    Time frame: Day1; Day14

Secondary outcomes

  1. Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)

    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)

    Time frame: Day1

  2. Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)

    Time to peak concentration at steady state (Tmax,ss)

    Time frame: Day14

07

Study locations

1 site
  • Clinical Research Division
    Taipei, 115, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02353273
Lead sponsor
Oneness Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Feb 2, 2015
Start date
Jul 22, 2015
Primary completion
Jul 5, 2016
Completion
Sep 5, 2016
Last update
Mar 29, 2018

Study contacts

Kai-Min Chu
principal investigator · Tri-Service General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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