Venous Leg UlcerPhase 3TRIVIANCT06707103
Tissue Repair Gel in Venous Leg Ulcers in AU/US
A Phase 3 study of Venous Leg Ulcer and Venous Ulcer, run by TR Therapeutics at 12 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Apr 2025to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
- Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
- The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
- Target ulcer age must be ≥ 4 weeks at Screening.
- Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler.
- Body mass index (BMI) ≤ 50 kg/m2.
- HbA1C ≤12%.
Who cannot join
- Target ulcer has been treated with prohibited medications or therapies.
- History of radiation at the target ulcer site.
- Target ulcer decreases in area by 30% or more during screening period.
- History of osteomyelitis at the target ulcer within 6 months of screening.
- History of cancer in the preceding 5 years (except as noted in the protocol).
- Participants considered nutritionally deficient.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Anhthu Nguyen Vice President, Global Clinical Operations contact
12 sites in 2 countries
Australia8 sites, 8 recruiting
- Not yet recruiting
Clincial Research Site 74
Bendigo, Victoria, 3550
info@trtherapeutics.com
- Not yet recruiting
Clincial Research Site 62
Camperdown, New South Wales, 2050
info@trtherapeutics.com
- Recruiting
Clincial Research Site 60
Ivanhoe, Victoria, 3079
info@trtherapeutics.com
- Not yet recruiting
Clinical Research Site 84
Kogarah, New South Wales, 2217
info@trtherapeutics.com
- Not yet recruiting
Clincial Research Site 75
Nedlands, Western Australia, 6009
info@trtherapeutics.com
- Not yet recruiting
Clincial Research Site 78
Orange, New South Wales, 2800
info@trtherapeutics.com
- Recruiting
Clincial Research Site 65
Shepparton, Victoria, 3630
info@trtherapeutics.com
- Not yet recruiting
Clincial Research Site 85
Sydney, New South Wales, 2065
info@trtherapeutics.com
United States4 sites, 4 recruiting
- Recruiting
Clincial Research Site 77
Clinton Twp, Michigan, 48038
- Recruiting
Clinical Research Site 76
Fort Worth, Texas, 76104
- Recruiting
Clincial Research Site 92
Jacksonville, Florida, 32256
- Not yet recruiting
Clincial Research Site 82
Lake Success, New York, 11042
About this study
Official title: A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.
Read the detailed description
This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).
The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Secondary endpoints include:
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
- Change from baseline in participant's perception of pain level at 12 weeks.
- Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
- Proportion of participants with any significant reduction in pain at or before 12 weeks.
There are also some supplementary and safety endpoints.
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wound
- Being tested
- TR987 0.1% gel + Standard of Care, Standard of care
- Keywords
- Tissue Repair, Glucoprime, TR Therapeutics, Debridement, VLU
- Medical subject headings
- Varicose Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR987 0.1% gel + Standard of CareDrug
Also called Glucoprime
6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
Standard of careOther
Standard of Care (wound cleansing/dressings and compression bandaging)
| Study group | Role | What they receive |
|---|---|---|
| TR987 0.1% gel + Standard of Care | Experimental | Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks. Receives: Drug: TR987 0.1% gel + Standard of Care |
| Standard of Care | Other | Participants will receive Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Patient count
Measured: 16 weeks
Secondary outcomes (5)
Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
Patient count
Measured: 16 weeks
Change from baseline in participant's perception of pain level at 12 weeks.
Pain to be measured on a 10 point numeric rating scale
Measured: 12 weeks
Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change
Measured: 12 and 16 weeks
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
Count the number of patients with complete closure and divide by the total number of patients
Measured: 12 weeks
Proportion of participants with any significant reduction in pain at or before 12 weeks.
Count the number of patients with any significant reduction in pain and divide by the total number of patients
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study startApr 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- Model description
- This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TR Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707103
- Sponsor's protocol ID
- BG003
- Acronym
- TRIVIA
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: If clinical trial data will be published, this relevant information may be available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)
- ClinicalTrials.gov ID
- NCT06707103
- Acronym / sponsor ID
- TRIVIA / BG003
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wound
- Keywords
- Tissue Repair, Glucoprime, TR Therapeutics, Debridement, VLU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- TR TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Nov 2024 (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 goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.
Detailed description
This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).
The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Secondary endpoints include:
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
- Change from baseline in participant's perception of pain level at 12 weeks.
- Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
- Proportion of participants with any significant reduction in pain at or before 12 weeks.
There are also some supplementary and safety endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).
| Arm | Type | Receives |
|---|---|---|
| TR987 0.1% gel + Standard of Care | Experimental | Drug: TR987 0.1% gel + Standard of CareParticipants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks. |
| Standard of Care | Other | Other: Standard of careParticipants will receive Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults 18 years and older
- Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
- Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
- The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
- Target ulcer age must be ≥ 4 weeks at Screening.
Key exclusion criteria (6 listed)
- Target ulcer has been treated with prohibited medications or therapies.
- History of radiation at the target ulcer site.
- Target ulcer decreases in area by 30% or more during screening period.
- History of osteomyelitis at the target ulcer within 6 months of screening.
- History of cancer in the preceding 5 years (except as noted in the protocol).
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 |
|---|---|---|
| TR987 0.1% gel + Standard of CareAlso: Glucoprime6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging) | Drug | TR987 0.1% gel + Standard of Care |
| Standard of careStandard of Care (wound cleansing/dressings and compression bandaging) | Other | Standard of Care |
Primary outcome
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Time frame: 16 weeks
Patient count
5 secondary outcomes
Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
Time frame: 16 weeks
Change from baseline in participant's perception of pain level at 12 weeks.
Time frame: 12 weeks
Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
Time frame: 12 and 16 weeks
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
Time frame: 12 weeks
Proportion of participants with any significant reduction in pain at or before 12 weeks.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. If clinical trial data will be published, this relevant information may be available.
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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.
Anhthu Nguyen Vice President, Global Clinical Operations contact
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Venous Leg Ulcer and Venous Ulcer, run by TR Therapeutics at 12 sites in 2 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anhthu Nguyen Vice President, Global Clinical Operations ((+61) 280 034 554, anhthu.nguyen@trtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit. (time frame: 16 weeks). 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 2 Apr 2025.