Chronic Diabetic Foot UlcersPhase 3NCT04962139
Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
A Phase 3 study testing ON101 Cream in people with Chronic Diabetic Foot Ulcers, run by Oneness Biotech Co., Ltd. at 14 sites in United States.
Trial summary
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Diabetic Foot Ulcers
- What is being tested?
- ON101 Cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 14 sitesUnited States
- Study dates
- 27 Jul 2021to 29 Nov 2022
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, male or female, aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin.
- Subject has a glycosylated hemoglobin, HbA1c ≦ 12%.
- Presence of at least one diabetic foot ulcer that meets all of the following criteria:
- A full-thickness ulcer of UTWCS Grade I-A or II-A
- Ulcer size (area) is > 1 cm2 and ≤ 20 cm2 (post-debridement at time of screening and randomization)
- Ulcer is located on or below the malleoli and presents duration of between 6 weeks and 12 months (at time of screening).
Show all 14Show fewer
- There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post-debridement)
- No active infection by clinical inspection as defined by IDSA/IWGDF criteria Note: If the subject has more than one qualifying diabetic foot ulcer, the most severe ulcer will be designated as the target ulcer.
- Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) > 0.8 and < 1.3, and transcutaneous pressure of oxygen (TcPO2) > 30 mmHg on at least one lead.
- Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening, must not be breastfeeding, and willing to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the study (excluding women who are not of childbearing potential and/or who have been sterilized).
- Subject should be able to walk and stand on the non-target ulcer limb.
- Subject is willing to use an off-loading device for the target ulcer on the plantar while ambulation for the duration of the study.
- Subject / identified caregiver trained on the study procedures is able and willing to comply with study procedures.
- A signed and dated informed consent form has been obtained from the subject prior to any study-related procedures being performed.
Who cannot join
- In response to standard of care, ulcer size reduction is > 30% during the two-week run-in Screening Period (between the first Screening Visit/V0 and Baseline/V2).
- Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) and X-ray findings.
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
- Body mass index (BMI) > 42 kg/m2
- Laboratory values at Screening of:
- White Blood Cells (WBC) < 3.0 X 109 cells/L；> 12.0 X 109 cells/L
Show all 31Show fewer
- Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
- Albumin < 2.5 g/dL
- Renal function studies [Serum Creatinine and Urea] > 3x the upper limit of normal
- Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the investigator, could interfere with wound healing, including but not limited to the following:
- Acute or unstable Charcot foot
- Current sepsis
- Active malignant disease. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- Acquired immune deficiency syndrome (AIDS) or HIV positive.
- Subject is currently receiving (i.e., within 30 days of randomization visit) or scheduled to receive any of following medication or therapies, could interfere with wound healing during the study.
- immunosuppressants (including chronic systemic corticosteroids)
- cytotoxic chemotherapy
- cytostatic therapy
- autoimmune disease therapy
- dialysis
- lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery)
- growth factors
- hyperbaric oxygen therapy
- bioengineered tissue or skin substitutes
- application of topical steroids to the ulcer
- use of any investigational drug(s)
- Subjects whose non-target ulcer limb is disabled or amputated above the ankle.
- Subject's target ulcer is located on the plantar foot with all toes amputated.
- Subjects who need to stand continuously for more than 4 hours / day and have difficulty complying with off-loading instruction.
- A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.
- Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Oneness Investigational Site
Carlsbad, California, 92009
Oneness Investigational Site
Castro Valley, California, 94546
Oneness Investigational Site
Dallas, Texas, 75251
Oneness Investigational Site
Fresno, California, 93710
Oneness Investigational Site
McAllen, Texas, 78501
Oneness Investigational Site
Mesa, Arizona, 85206
Oneness Investigational Site
Miami, Florida, 33165
Oneness Investigational Site
Miami Lakes, Florida, 33016
Oneness Investigational Site
Mount Prospect, Illinois, 60056
Oneness Investigational Site
North Miami Beach, Florida, 33321
Oneness Investigational Site
O'Fallon, Illinois, 62269
Oneness Investigational Site
San Francisco, California, 94117
Oneness Investigational Site
Springfield, Illinois, 62704
Oneness Investigational Site
Sylmar, California, 91342
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Phase-III Study to Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
- Conditions
- Chronic Diabetic Foot Ulcers
- Being tested
- ON101 Cream, Vehicle Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON101 CreamDrug
Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica
Vehicle CreamOther
ON101 Cream Placebo
| Study group | Role | What they receive |
|---|---|---|
| ON101 Cream plus Standard of Care | Experimental | ON101 cream will be applied twice daily for up to 20 weeks to the Target Ulcer. The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary. Receives: Drug: ON101 Cream |
| Vehicle Cream plus Standard of Care | Placebo comparator | Vehicle cream will be applied twice daily for up to 20 weeks to the Target Ulcer.
The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary. Receives: Other: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with complete closure of Target Ulcer
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by blinded independent evaluators.
Measured: 20-week Treatment Phase
Secondary outcomes (3)
Time to complete closure of Target Ulcer
Time to complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by blinded independent evaluators.
Measured: 20-week Treatment Phase
The proportion of patients with Target Ulcer recurrence
The proportion of patients with Target Ulcer recurrence during the Follow-Up Phase.
Measured: 12-week Follow-Up Phase
Mean change in EQ-5D-5L utility score
Mean change from baseline in EQ-5D-5L utility score at V12/EOT.
Measured: Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start27 Jul 2021
- Primary completion1 Nov 2022
- Study completion29 Nov 2022
Why it stopped: Due to the product development strategy adjustment, the Sponsor terminated this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shyi-Gen Chen, Study director, Oneness Biotech Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962139
- Sponsor's protocol ID
- ON101CLCT04
- Status last verified
- Mar 2025
- First submitted
- 2 Jul 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Phase-III Study to Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04962139
- Acronym / sponsor ID
- ON101CLCT04
- Conditions
- Chronic Diabetic Foot Ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the product development strategy adjustment, the Sponsor terminated this study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 14 Jul 2021 (actual)
- 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 primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON101 Cream plus Standard of Care | Experimental | Drug: ON101 CreamON101 cream will be applied twice daily for up to 20 weeks to the Target Ulcer. The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary. |
| Vehicle Cream plus Standard of Care | Placebo comparator | Other: Vehicle CreamVehicle cream will be applied twice daily for up to 20 weeks to the Target Ulcer. The SOC will include evaluation to ensure adequate blood flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment via regular dressing changes, and management of infection through oral antibiotics, if necessary. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects, male or female, aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin.
- Subject has a glycosylated hemoglobin, HbA1c ≦ 12%.
- Presence of at least one diabetic foot ulcer that meets all of the following criteria:
- Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) > 0.8 and < 1.3, and transcutaneous pressure of oxygen (TcPO2) > 30 mmHg on at least one lead.
- Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening, must not be breastfeeding, and willing to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the study (excluding women who are not of childbearing potential and/or who have been sterilized).
Key exclusion criteria (31 listed)
- In response to standard of care, ulcer size reduction is > 30% during the two-week run-in Screening Period (between the first Screening Visit/V0 and Baseline/V2).
- Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) and X-ray findings.
- Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
- Body mass index (BMI) > 42 kg/m2
- Laboratory values at Screening of:
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 CreamActive ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica | Drug | ON101 Cream plus Standard of Care |
| Vehicle CreamON101 Cream Placebo | Other | Vehicle Cream plus Standard of Care |
Primary outcome
The proportion of subjects with complete closure of Target Ulcer
Time frame: 20-week Treatment Phase
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by blinded independent evaluators.
3 secondary outcomes
Time to complete closure of Target Ulcer
Time frame: 20-week Treatment Phase
The proportion of patients with Target Ulcer recurrence
Time frame: 12-week Follow-Up Phase
Mean change in EQ-5D-5L utility score
Time frame: Day 141
Results and safety
The study was stopped early (reason given: Due to the product development strategy adjustment, the Sponsor terminated this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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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.
Shyi-Gen Chen study director
Oneness Biotech Co., Ltd.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ON101 Cream in people with Chronic Diabetic Foot Ulcers, run by Oneness Biotech Co., Ltd. at 14 sites in United States.
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 14 inclusion and 31 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: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Due to the product development strategy adjustment, the Sponsor terminated this study.). Results are not available in the source record.
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?
The proportion of subjects with complete closure of Target Ulcer (time frame: 20-week Treatment Phase). 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 13 Mar 2025.