Tissue Repair Gel for Venous Leg Ulcers

(TRIVIA Trial)

Recruiting at 20 trial locations

Overseen By Anhthu Nguyen Vice President, Global Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: TR Therapeutics

Disqualifiers: Radiation, Osteomyelitis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

312 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new gel, TR987 0.1% (Tissue Repair Gel), used alongside standard care, can heal Venous Leg Ulcers (VLUs) more effectively than standard care alone. VLUs are painful leg wounds that can be difficult to heal. The trial will also assess the gel's safety. Individuals with a VLU measuring between 2 cm and 12 cm and present for at least 4 weeks may qualify for this study. Participants will receive either the new gel with regular treatments or just the regular treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your ulcer has been treated with certain prohibited medications or therapies, you may not be eligible to participate.

Is there any evidence suggesting that TR987 0.1% gel is likely to be safe for humans?

Research has shown that TR987 0.1% gel was promising in earlier trials. Studies have confirmed its safety, particularly for treating ulcers caused by poor blood flow in the legs. Reports indicate that most people tolerate the gel well, experiencing only mild and manageable side effects. This suggests that users generally did not encounter serious problems. Additionally, the trial's later stage implies that previous research has provided strong safety evidence for TR987 0.1% gel. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for venous leg ulcers, which typically involves wound cleansing, dressings, and compression bandaging, the TR987 0.1% gel offers a novel approach with its unique tissue repair properties. Researchers are excited about this treatment because it combines standard care methods with a specialized gel applied topically, potentially enhancing healing by actively promoting tissue repair. This dual approach may provide more effective and faster healing compared to traditional methods alone, which is why it holds promise for better outcomes in managing venous leg ulcers.

What evidence suggests that TR987 0.1% gel might be an effective treatment for Venous Leg Ulcers?

Research shows that TR987 0.1% gel, which participants in this trial may receive, may help treat Venous Leg Ulcers (VLUs). Studies have found that using this gel along with usual care can greatly improve skin healing. Early results suggest that TR987 activates certain cells called macrophages, which play a crucial role in wound healing. Patients who used the gel experienced better skin quality. Evidence also indicates that this treatment is safe and effective for managing chronic venous ulcers, which are similar to VLUs. Overall, the data supports that TR987 0.1% gel can improve ulcer healing when used with standard treatments. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with venous leg ulcers, which are wounds that don't heal well due to poor blood flow in the veins. Participants should have a history of these ulcers and be able to follow the study's treatment plan. Specific details about who can or cannot participate were not provided.

Inclusion Criteria

I have been diagnosed with venous insufficiency.

My blood flow in arteries is confirmed to be adequate.

My venous ulcer is between 2 and 12 cm2 in size.

Exclusion Criteria

My ulcer has shrunk by at least 30% during the screening.

My ulcer has not been treated with any forbidden medications or therapies.

Participants considered nutritionally deficient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TR987 0.1% gel + Standard of Care or Standard of Care alone for up to 16 weeks

16 weeks

Twice weekly for the first 4 weeks, then weekly for the remaining 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ulcer closure status at 3 months

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TR987 0.1% gel

Trial Overview The trial is testing if TR987 0.1% gel, when used alongside standard wound care practices, is more effective at healing venous leg ulcers than standard care alone.

How Is the Trial Designed?

Group I: TR987 0.1% gel + Standard of Care Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Experimental Treatment 1 Intervention

TR987 0.1% gel is already approved in United States for the following indications:

Approved in United States as TR987 for:

• Venous Leg Ulcers

Who Is Running the Clinical Trial?

TR Therapeutics

Lead Sponsor

Trials

5

Recruited

740+

Published Research Related to This Trial

Two patients with venous leg ulcers (VLUs) that had not healed for 11 and 3 years, respectively, were successfully treated with a poly-N-acetyl glucosamine-derived membrane (pGlcNAc) in addition to standard compression bandaging.

Both patients experienced complete healing within 6 weeks of the first application of pGlcNAc, suggesting that this novel treatment could be effective for ulcers that are resistant to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of two refractory venous stasis ulcers treated with a novel poly-N-acetyl glucosamine-derived membrane. Maus, EA.[2021]

The Tegaderm superabsorber (TS) dressing demonstrated a significantly higher exudate absorption capacity (72.8%) compared to the traditional Zetuvit dressing (36.5%), indicating its superior ability to manage fluid in venous leg ulcers (VLUs).

TS was also effective in trapping and retaining harmful proteases like MMP-2 and PMN elastase, which are associated with impaired healing in VLUs, suggesting that it could enhance treatment outcomes by preventing these enzymes from interfering with the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exudates absorption and proteases trapping in venous leg ulcers. Humbert, P., Courderot-Masuyer, C., Robin, S., et al.[2019]

In a study of 13 patients with chronic venous leg ulcers (VLUs), Apligraf treatment led to a significant average reduction of 60.5% in ulcer size, with some ulcers showing over 75% reduction after treatment, demonstrating its efficacy in clinical practice.

The economic evaluation indicated that Apligraf treatment resulted in lower ulcer-related medical costs per unit change in ulcer size compared to conventional compression therapy, highlighting its cost-effectiveness in managing VLUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and economic impact of Apligraf for the treatment of nonhealing venous leg ulcers. Fivenson, D., Scherschun, L.[2019]

In a study of 44 patients with chronic venous leg ulcers, 38.7% reported using traditional Chinese medicaments (TTCM), and 41% of those tested positive for sensitization to TTCM, indicating a potential link between TTCM use and allergic reactions.

Patients with a history of TTCM usage had a significantly higher sensitization rate (94.1%) compared to those without such a history (45.8%), suggesting that TTCM may contribute to non-healing or poorly healing leg ulcers and should be considered in clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of topical traditional chinese medicaments as contact sensitisers in chronic venous leg ulcer patients. Lim, KS., Tang, MB., Goon, AT., et al.[2020]

A study involving 30 diabetic patients with neuropathic leg ulcers showed that using a novel gel formulation (Vulnamin) alongside elastocompression significantly improved healing rates compared to an inert gel vehicle.

Patients treated with Vulnamin gel experienced faster healing times, greater reductions in ulcer area, and higher overall satisfaction, while the treatment was found to be safe with no significant increase in infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of a novel gel dressing in the management of neuropathic leg ulcers in diabetic patients: a prospective double-blind randomized trial. Abbruzzese, L., Rizzo, L., Fanelli, G., et al.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06707103

Tissue Repair Gel in Venous Leg Ulcers in AU/US 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).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9719830/

A Novel Macrophage-Activating Gel Improves Healing and ... The validated 3- and 9-point FGWS was used to evaluate the effectiveness of the TR-987 0.1% gel in optimizing skin quality after procedure versus placebo gel.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03154619

NCT03154619 | Efficacy of TR 987, Beta-1,3-1,6-D-glucan, ... The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of chronic venous insufficiency ulcers has been established. This ...

4. withpower.com withpower.com/trial/phase-3-varicose-ulcer-10-2024-1d253

TR987 Gel for Venous Leg Ulcers (TRIVIA Trial) 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).

5. listcorp.com listcorp.com/asx/trp/tissue-repair-ltd/news/phase-3-clinical-trial-programme-for-tr987-3144623.html

Phase 3 Clinical Trial Programme for TR987 The Phase 3 program aims to confirm the promising results of previous studies, which demonstrated TR987®'s potential to significantly improve ...

6. ctv.veeva.com ctv.veeva.com/study/tissue-repair-gel-in-venous-leg-ulcers-us

Tissue Repair Gel in Venous Leg Ulcers (US) (TRIVIA) It will also provide additional information about the safety of drug TR987 0.1% gel. Full description.

7. tissuerepair.com.au tissuerepair.com.au/clinical-program/

Clinical Program Tissue Repair has commenced preparatory work for the TR-987 Phase III clinical trial on venous leg ulcers and is expecting the study to take an estimated 36 ...