Tissue Repair Gel for Venous Leg Ulcers

(TRIVIA Trial)

Recruiting at 18 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

Trial Summary

What is the purpose of this 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). It will also provide additional information about the safety of drug TR987 0.1% gel.

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.

How is the drug TR987 gel different from other treatments for venous leg ulcers?

TR987 gel is unique because it is a topical gel formulation specifically designed for venous leg ulcers, potentially offering a novel mechanism of action compared to traditional compression therapy and dressings. While other treatments like Apligraf and poly-N-acetyl glucosamine-derived membranes have shown effectiveness, TR987 gel may provide an alternative option with its specific formulation and application method. ^{1 2 3 4 5}

Eligibility Criteria

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 am 18 years old or older.

I have been diagnosed with venous insufficiency.

My blood flow in arteries is confirmed to be adequate.

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.

I have not had any cancer in the last 5 years, except for types allowed in the study.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exudates absorption and proteases trapping in venous leg ulcers. [2019]

2. Singapore pubmed.ncbi.nlm.nih.gov

The role of topical traditional chinese medicaments as contact sensitisers in chronic venous leg ulcer patients. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Clinical and economic impact of Apligraf for the treatment of nonhealing venous leg ulcers. [2019]