Venous Leg UlcerPhase 3TRIVIANCT06707090
Tissue Repair Gel in Venous Leg Ulcers (US)
A Phase 3 study of Venous Leg Ulcer and Venous Ulcer, run by TR Therapeutics at 33 sites in United States.
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
- 33 sitesUnited States
- Study dates
- 28 Jan 2025to Feb 2028
- 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.
- Participants considered nutritionally deficient.
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anhthu Nguyen Vice President, Global Clinical Operations contact
33 sites in 1 country
United States33 sites, 27 recruiting
- Recruiting
Clincial Research Site 04
Bossier City, Louisiana, 71111
info@trtherapeutics.com
- Recruiting
Clincial Research Site 43C
Castro Valley, California, 94546
info@trtherapeutics.com
- Not yet recruiting
Clincial Research Site 22
Chicago, Illinois, 60611
- Recruiting
Clincial Research Site 34
Chicago, Illinois, 60649
info@trtherapeutics.com
- Recruiting
Clincial Research Site 07
D'Iberville, Mississippi, 39540
info@trtherapeutics.com
- Active, not recruiting
Clincial Research Site 47
Deerfield Beach, Florida, 33442
- Recruiting
Clincial Research Site 24
Fort Worth, Texas, 76104
info@trtherapeutics.com
- Recruiting
Clincial Research Site 14
Fresno, California, 93710
info@trtherapeutics.com
- Withdrawn
Clincial Research Site 45
Grove City, Ohio, 43123
- Not yet recruiting
Clincial Research Site 38
Hollywood, Florida, 33021
info@trtherapeutics.com
- Recruiting
Clincial Research Site 32
Houston, Texas, 27707
info@trtherapeutics.com
- Recruiting
Clincial Research Site 40
Jacksonville, Florida, 32209
info@trtherapeutics.com
- Recruiting
Clincial Research Site 01
Lafayette, Louisiana, 70507
info@trtherapeutics.com
- Recruiting
Clincial Research Site 11
Los Angeles, California, 90063
info@trtherapeutics.com
- Recruiting
Clincial Research Site 02
McComb, Mississippi, 39648
info@trtherapeutics.com
- Withdrawn
Clincial Research Site 23
Mentor, Ohio, 44060
- Recruiting
Clincial Research Site 19
Miami, Florida, 33150
info@trtherapeutics.com
- Recruiting
Clincial Research Site 26
Miami, Florida, 33156
info@trtherapeutics.com
- Recruiting
Clincial Research Site 30
New York, New York, 10019
info@trtherapeutics.com
- Recruiting
Clincial Research Site 10
O'Fallon, Illinois, 62269
info@trtherapeutics.com
- Recruiting
Clincial Research Site 13
Pembrook Pines, Florida, 33026
info@trtherapeutics.com
- Recruiting
Clincial Research Site 36
Philadelphia, Pennsylvania, 19107
info@trtherapeutics.com
- Not yet recruiting
Clincial Research Site 46
San Antonio, Texas, 78224
info@trtherapeutics.com
- Recruiting
Clincial Research Site 43A
San Francisco, California, 94115
info@trtherapeutics.com
- Recruiting
Clincial Research Site 43B
San Francisco, California, 94117
info@trtherapeutics.com
- Recruiting
Clincial Research Site 49
Springfield, Illinois, 62704
info@trtherapeutics.com
- Recruiting
Clincial Research Site 18
Suffolk, Virginia, 23434
info@trtherapeutics.com
- Recruiting
Clincial Research Site 37
Syosset, New York, 11791
info@trtherapeutics.com
- Withdrawn
Clincial Research Site 51
Tamarac, Florida, 33321
- Active, not recruiting
Clincial Research Site 21
Tucson, Arizona, 85715
- Recruiting
Clincial Research Site 28
Tulsa, Oklahoma, 74137
info@trtherapeutics.com
- Recruiting
Clincial Research Site 54
Vista, California, 92081
info@trtherapeutics.com
- Active, not recruiting
Clincial Research Site 55
Winston-Salem, North Carolina, 27157
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, Wounds
- 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
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 | Not described 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 (8)
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
Proportion of target ulcers which reach greater than 70% closure at 12 weeks and 16 weeks
Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)
Measured: 12 and 16 weeks
Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks
Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)
Measured: 12 and 16 weeks
Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks
Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)
Measured: 12 and 16 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 start28 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (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
- NCT06707090
- Sponsor's protocol ID
- BG002
- Acronym
- TRIVIA
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: If the clinical data will be published, the relevant information may be made available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. 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
- NCT06707090
- Acronym / sponsor ID
- TRIVIA / BG002
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wounds
- 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
- 28 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (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 care |
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 (5 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.
- Participants considered nutritionally deficient.
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 Care6mg 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
8 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
Proportion of target ulcers which reach greater than 70% closure at 12 weeks and 16 weeks
Time frame: 12 and 16 weeks
Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks
Time frame: 12 and 16 weeks
Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks
Time frame: 12 and 16 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 12 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. If the clinical data will be published, the relevant information may be made 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
33 sites in 1 country: 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 33 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 8 inclusion and 5 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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. 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 12 Feb 2026.