Diabetic Foot UlcersNCT04945161
A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.
A study testing ON101 Cream in people with Diabetic Foot Ulcers, run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.
Trial summary
The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream. Primary endpoint: Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level. Secondary endpoints: 1. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Feb 2021to 24 Dec 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects, male or female, aged 20 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control.
- Subjects has a glycosylated hemoglobin, HbA1c < 12%.
- Presence of at least one diabetic foot ulcer that meets all of the following criteria:
- At the time of Visit 0 (V0), the ulcer has existed for at least one month;
- At the time of Visit 1 (V1), the post-debridement ulcer presents Grade 2 or Grade 3 (without osteomyelitis or active infection) in Wagner Ulcer Classification System assessment; and
- Area should be ≥ 4 cm2 and ≤ 25 cm2;
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- No higher than the ankle.
- Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3.
- Clinically normal resting ECG at the first Screening Visit (V0) or, if abnormal, considered to be not clinically significant by the Investigator.
- Subject must use an off-loading method for the target ulcer on the plantar during the whole study period.
- Subject, if female of child-bearing potential, has a negative pregnancy test on urine at screening, must not be breastfeeding, and willing to use two 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 contraceptives rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and/or who have been sterilized).
- Subject is able and willing to comply with the study procedures.
- A signed and dated informed consent form has been obtained from the subject.
Who cannot join
- In response to standard of care (SoC), ulcer size reduction is ≥20% during the two-week run-in screening period (between the first Screening Visit/V0 and Baseline Visit/V1).
- Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings where find necessary by the Investigator.
- Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement.
- Laboratory values at Screening of:
- Liver function test (total bilirubin, aspartate aminotransferase [AST], or alanine transaminase [ALT]) > 3x the upper limit of normal, or
- Albumin < 2.5 g/dL, or
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- Renal function test (serum creatinine or urea) > 2x 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, maybe 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 the following medication or therapies, could interfere with wound healing during the course of the study:
- Immunosuppressive or chemotherapeutic agents, radiotherapy, or systemic corticosteroids
- Autoimmune disease therapy
- Lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery)
- Hyperbaric oxygen therapy
- Bioengineered tissue or skin substitutes
- Use of any investigational drug(s)
- Cell therapy
- More than two (2) ulcers located on or below the malleoli on the target foot.
- 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.
- Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the study.
- Body mass index (BMI) >40 with plantar ulcer.
- Heavy smoker (>1 pack per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Explore the Mechanism of Action (MOA) of ON101 Cream in Patients With Diabetic Foot Ulcers (DFUs).
The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
Primary endpoint:
Read more
Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level.
Secondary endpoints:
- Comparison of the gene and/or protein expression level of individual target between ON101 and Placebo groups
- Change from baseline in the wound microbiota composition in each group
- Comparison of the wound microbiota composition between ON101 and Placebo groups
- Comparison of the wound reduction rate in each group
- Correlation of wound reduction rate with the alternated level of each target gene in each group.
Safety endpoints:
Incidence of treatment-emergent adverse event (AE) Change from baseline in vital signs, physical examination, and laboratory tests
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to explore the mechanism of action (MOA) of ON101 in treating chronic diabetic foot ulcers (DFUs). There will be 6 subjects ON101 treatment (Arm A) and 6 subjects in Placebo (Arm B) .
Twelve(12) eligible subjects with DFUs and are not undergoing dialysis will be enrolled and randomly assigned to receive either ON101 treatment (Arm A) or Placebo (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided throughout the study period.Subjects with DFUs not undergoing dialysis, N = 12 Arm A: ON101 plus SoC, N = 6 Arm B: Placebo plus SoC, N =6 SoC will be provided throughout the study period (from screening to end of treatment). SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary.
The study will have three periods, a Screening/Run-in Period, a Treatment Period, and a Safety Follow-up Period.
Screening/Run-in Period (14 days):
Treatment Period (up to 6 weeks ± allow window):
There will be five (5) visits during the Treatment Period. Baseline/V1 (Day 1 ± 3 days) Visit 2 to Visit 5/EOT (Day 14 to Day 42/EOT) Safety Follow-up Period (Day 49±1 or Day of EOT + 6-8 days)
- Conditions
- Diabetic Foot Ulcers
- Being tested
- ON101 Cream, Placebo
- 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
Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm A: N = 6 ON101 plus SoC | Experimental | Twelve (12) eligible subjects with DFUs will be enrolled. These 12 subjects will be randomly assigned to receive either ON101 treatment plus SoC (Arm A) or Placebo plus SoC (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion.
SoC will be provided from screening to the end of treatment. The SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary. Receives: Drug: ON101 Cream |
| Arm B: N = 6 Placebo plus SoC | Placebo comparator | Twelve (12) eligible subjects with DFUs will be enrolled. These 12 subjects will be randomly assigned to receive either ON101 treatment plus SoC (Arm A) or Placebo plus SoC (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion.
SoC will be provided from screening to the end of treatment. The SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint:Q-RT-PCR, for the inflammation stage and the remodeling stage
Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level, usch as Q-RT-PCR, Cytokine, Chmokine, GFs.
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Secondary endpoint (1): IL-1b, IL-6, TNF, TGF, CXCL9, FGF2, and IL1RN!..ect.
Comparison of the gene and/or protein expression level of individual target between ON101 and Placebo groups, through Q-RT-PCR, between inflammation stage and remodeling stage
Measured: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (2): iNOS, CD86, CD80, CD163, CD206, KRT14, MMP12..ect.
Change from baseline in the wound microbiota composition in each group, through IHC, analysis macrophage marker, epithelization, fibroblast maker, collagen, EPC and angiogenesis
Measured: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (3): CO15A1, CD71, CD34..ect
Comparison of the wound microbiota composition between ON101 and Placebo groups, through IHC, between inflammation stage and remodeling stage.
Measured: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (4):target ulcer size evaluation report (Area: perimeter, length, width )
Comparison of the wound reduction rate in each group,through target ulcer size evaluation report (Area: perimeter, length, width )
Measured: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (5): wound reduction rate of each target gene in each group
Correlation of wound reduction rate with the alternated level of each target gene in each group, through IHC and target ulcer report.
Measured: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start23 Feb 2021
- Primary completion9 Nov 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled clinical study to explore the mechanism of action (MOA) of ON101 cream in patients with diabetic foot ulcers (DFUs).The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945161
- Sponsor's protocol ID
- ON101CLIIS01-DFU
- Status last verified
- Jan 2023
- First submitted
- 22 Mar 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IIS study
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Study to Explore the Mechanism of Action (MOA) of ON101 Cream in Patients With Diabetic Foot Ulcers (DFUs).
- ClinicalTrials.gov ID
- NCT04945161
- Acronym / sponsor ID
- ON101CLIIS01-DFU
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 30 Jun 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 objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
Primary endpoint:
Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level.
Secondary endpoints:
- Comparison of the gene and/or protein expression level of individual target between ON101 and Placebo groups
- Change from baseline in the wound microbiota composition in each group
- Comparison of the wound microbiota composition between ON101 and Placebo groups
- Comparison of the wound reduction rate in each group
- Correlation of wound reduction rate with the alternated level of each target gene in each group.
Safety endpoints:
Incidence of treatment-emergent adverse event (AE) Change from baseline in vital signs, physical examination, and laboratory tests
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to explore the mechanism of action (MOA) of ON101 in treating chronic diabetic foot ulcers (DFUs). There will be 6 subjects ON101 treatment (Arm A) and 6 subjects in Placebo (Arm B) .
Twelve(12) eligible subjects with DFUs and are not undergoing dialysis will be enrolled and randomly assigned to receive either ON101 treatment (Arm A) or Placebo (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided throughout the study period.Subjects with DFUs not undergoing dialysis, N = 12 Arm A: ON101 plus SoC, N = 6 Arm B: Placebo plus SoC, N =6 SoC will be provided throughout the study period (from screening to end of treatment). SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary.
The study will have three periods, a Screening/Run-in Period, a Treatment Period, and a Safety Follow-up Period.
Screening/Run-in Period (14 days):
Treatment Period (up to 6 weeks ± allow window):
There will be five (5) visits during the Treatment Period. Baseline/V1 (Day 1 ± 3 days) Visit 2 to Visit 5/EOT (Day 14 to Day 42/EOT) Safety Follow-up Period (Day 49±1 or Day of EOT + 6-8 days)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled clinical study to explore the mechanism of action (MOA) of ON101 cream in patients with diabetic foot ulcers (DFUs).The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
| Arm | Type | Receives |
|---|---|---|
| Arm A: N = 6 ON101 plus SoC | Experimental | Drug: ON101 CreamTwelve (12) eligible subjects with DFUs will be enrolled. These 12 subjects will be randomly assigned to receive either ON101 treatment plus SoC (Arm A) or Placebo plus SoC (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided from screening to the end of treatment. The SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary. |
| Arm B: N = 6 Placebo plus SoC | Placebo comparator | Other: PlaceboTwelve (12) eligible subjects with DFUs will be enrolled. These 12 subjects will be randomly assigned to receive either ON101 treatment plus SoC (Arm A) or Placebo plus SoC (Arm B) for six weeks. Treatment arm allocation will be done through randomization in a double-blind fashion. SoC will be provided from screening to the end of treatment. The SoC includes evaluation to ensure adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment via regular changing of dressings, and management of infection through oral antibiotics, if necessary. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects, male or female, aged 20 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control.
- Subjects 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.
- Clinically normal resting ECG at the first Screening Visit (V0) or, if abnormal, considered to be not clinically significant by the Investigator.
Key exclusion criteria (25 listed)
- In response to standard of care (SoC), ulcer size reduction is ≥20% during the two-week run-in screening period (between the first Screening Visit/V0 and Baseline Visit/V1).
- Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings where find necessary by the Investigator.
- Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement.
- Laboratory values at Screening of:
- 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:
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 | Arm A: N = 6 ON101 plus SoC |
| PlaceboPlacebo | Other | Arm B: N = 6 Placebo plus SoC |
Primary outcome
Primary endpoint:Q-RT-PCR, for the inflammation stage and the remodeling stage
Time frame: Through study completion, an average of 1 year
Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level, usch as Q-RT-PCR, Cytokine, Chmokine, GFs.
5 secondary outcomes
Secondary endpoint (1): IL-1b, IL-6, TNF, TGF, CXCL9, FGF2, and IL1RN!..ect.
Time frame: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (2): iNOS, CD86, CD80, CD163, CD206, KRT14, MMP12..ect.
Time frame: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (3): CO15A1, CD71, CD34..ect
Time frame: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (4):target ulcer size evaluation report (Area: perimeter, length, width )
Time frame: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
Secondary endpoint (5): wound reduction rate of each target gene in each group
Time frame: Based on each visit window for the first review, and through study completion, an average of 1 year for the final review
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 5 Jan 2023.
- Individual participant dataSharing planned: No. IIS study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ON101 Cream in people with Diabetic Foot Ulcers, 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 13 inclusion and 25 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 5 Jan 2023. 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. 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.
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?
Primary endpoint:Q-RT-PCR, for the inflammation stage and the remodeling stage (time frame: Through study completion, an average of 1 year). 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 5 Jan 2023.