Diabetic FootPhase 1NCT02353273
The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
A Phase 1 study testing WH-1 ointment in people with Diabetic Foot, run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- WH-1 ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2015to 5 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- No-infected;
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetic Foot
- Being tested
- WH-1 ointment
- Keywords
- WH-1,Diabetic Foot,Ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WH-1 ointmentDrug
Also called No other intervention drug
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.
| Study group | Role | What they receive |
|---|---|---|
| WH-1 ointment | Experimental | WH-1 ointment(1.25%),15g ointment per tube. Receives: Drug: WH-1 ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)
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)
Cmax,ss, AUC0-τ:
- 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).
Measured: Day1; Day14
Secondary outcomes (2)
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)
- Time to peak concentration (Tmax)
- Mean residence time (MRT)
- Elimination half-life (T1/2)
- Apparent volume of distribution (Vd/F)
- Apparent clearance (CL/F)
Measured: Day1
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)
Time to peak concentration at steady state (Tmax,ss)
Measured: Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start22 Jul 2015
- Primary completion5 Jul 2016
- Study completion5 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai-Min Chu, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353273
- Sponsor's protocol ID
- ON101CLPK01
- Status last verified
- Mar 2018
- First submitted
- 21 Jan 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02353273
- Acronym / sponsor ID
- ON101CLPK01
- Conditions
- Diabetic Foot
- Keywords
- WH-1,Diabetic Foot,Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2015 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 5 Sep 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WH-1 ointment | Experimental | Drug: WH-1 ointmentWH-1 ointment(1.25%),15g ointment per tube. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WH-1 ointmentAlso: No other intervention drugEach 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. | Drug | WH-1 ointment |
Primary outcome
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).
2 secondary outcomes
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)
Time frame: Day1
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)
Time frame: Day14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai-Min Chu principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WH-1 ointment in people with Diabetic Foot, run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ) (time frame: Day1; Day14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.