Diabetic FootPhase 3NCT01898923
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
A Phase 3 study testing ON101 Cream and Aquacel® Hydrofiber® dressing in people with Diabetic Foot, run by Oneness Biotech Co., Ltd. at 21 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- ON101 Cream and Aquacel® Hydrofiber® dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 23 Nov 2012to 11 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed a written informed consent prior to the first study evaluation;
- Male or female is at least 20 and < 80 years of age;
- Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization;
- An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;
- The target ulcer must have the following characteristics:
- Grade 1 or 2 per Wagner Ulcer Classification System;
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- No higher than the ankle;
- No active infected;
- A cross-sectional area of between 1 and 25 cm2 post-debridement;
- Present for at least 4 weeks before randomization;
- If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit;
- Able and willing to attend the scheduled visits and comply with study procedures.
Who cannot join
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
- Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
- Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization;
- Poor nutritional status defined as an albumin < 2.5 g/dL;
- Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit;
- Serum Creatinine >2 x the normal upper limit;
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- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization;
- Use of any investigational drug or therapy within the 4 weeks prior to randomization;
- 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;
- Judged by the investigator not to be suitable for the study for any other reason.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
Taiwan11 sites
Chang Gung Medical Hospital_Kaohsiung
Kaohsiung City
Buddhist Tzu Chi Medical Hospital
New Taipei City
MacKay Memorial Hospital-Tamsui Branch
New Taipei City
China Medical University Hospital
Taichung
Chi Mei Medical Center-Yongkang
Tainan
MacKay Memorial Hospital-Taipei Branch
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Medical Hospital_Linkou
Taoyuan City
China Medical University Hospital-Beigang Branch
Yunlin, 651
China9 sites
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Nanfang Hospital of Southern Medical University
Guanzhou, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangdong
Shandong Provincial Hospital
Jinan, Shandong
The First Affiliated Hospital of Henan Science & Technology University
Luoyang, Henan
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai TCM-Interated Hospital
Shanghai, Shanghai Municipality
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.
Read the detailed description
This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects' treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit.
One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.
- Conditions
- Diabetic Foot
- Being tested
- ON101 Cream, Aquacel® Hydrofiber® dressing
- 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.
ON101 CreamDrug
Also called WH-1
Aquacel® Hydrofiber® dressingOther
| Study group | Role | What they receive |
|---|---|---|
| ON101 Cream | Experimental | ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. Receives: Drug: ON101 Cream |
| Aquacel® Hydrofiber® dressing | Other | Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Receives: Other: Aquacel® Hydrofiber® dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Ulcer Closure
The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment.
For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.
Measured: 16 weeks
Secondary outcomes (4)
The Time of Healing Rate
Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.
Measured: 16 weeks
Change in Ulcer Area
Percentage change in ulcer surface area from baseline
Measured: 16 weeks
Percentage of Participants With a 50% Reduction of Ulcer Surface Area
Percentage of subjects with a 50% reduction of ulcer surface area
Measured: 16 weeks
Incidence of Infection of the Target Ulcer
Incidence of infection of the target ulcer
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start23 Nov 2012
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Chang, Study director, Oneness Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898923
- Sponsor's protocol ID
- ON101CLCT02
- Status last verified
- Mar 2021
- First submitted
- 8 Jul 2013
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Huang YY, Lin CW, Cheng NC, Cazzell SM, Chen HH, Huang KF, Tung KY, Huang HL, Lin PY, Perng CK, Shi B, Liu C, Ma Y, Cao Y, Li Y, Xue Y, Yan L, Li Q, Ning G, Chang SC. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122607. doi: 10.1001/jamanetworkopen.2021.22607.
PubMed 34477854
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01898923
- Acronym / sponsor ID
- ON101CLCT02
- Conditions
- Diabetic Foot
- Keywords
- WH-1,Diabetic Foot,Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2012 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.
Detailed description
This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects' treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit.
One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON101 Cream | Experimental | Drug: ON101 CreamON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. |
| Aquacel® Hydrofiber® dressing | Other | Other: Aquacel® Hydrofiber® dressingAquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Has signed a written informed consent prior to the first study evaluation;
- Male or female is at least 20 and < 80 years of age;
- Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization;
- An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;
- The target ulcer must have the following characteristics:
Key exclusion criteria (10 listed)
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
- Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
- Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization;
- Poor nutritional status defined as an albumin < 2.5 g/dL;
- Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit;
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 |
|---|---|---|
| ON101 CreamAlso: WH-1 | Drug | ON101 Cream |
| Aquacel® Hydrofiber® dressing | Other | Aquacel® Hydrofiber® dressing |
Primary outcome
Number of Participants With Complete Ulcer Closure
Time frame: 16 weeks
The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment. For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.
4 secondary outcomes
The Time of Healing Rate
Time frame: 16 weeks
Change in Ulcer Area
Time frame: 16 weeks
Percentage of Participants With a 50% Reduction of Ulcer Surface Area
Time frame: 16 weeks
Incidence of Infection of the Target Ulcer
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34477854Huang YY, Lin CW, Cheng NC, Cazzell SM, Chen HH, Huang KF, Tung KY, Huang HL, Lin PY, Perng CK, Shi B, Liu C, Ma Y, Cao Y, Li Y, Xue Y, Yan L, Li Q, Ning G, Chang SC. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122607. doi: 10.1001/jamanetworkopen.2021.22607.
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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.
Henry Chang study director
Oneness Biotech
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ON101 Cream and Aquacel® Hydrofiber® dressing in people with Diabetic Foot, run by Oneness Biotech Co., Ltd. at 21 sites in 3 countries.
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 12 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Taiwan, China, United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Ulcer Closure (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01898923, which also lists 1 linked publication.
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 14 Apr 2021.