TR987 Gel for Venous Leg Ulcers

(TRIVIA Trial)

Recruiting at 11 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 using TR987 0.1% gel (a topical treatment) alongside standard care can heal venous leg ulcers (VLUs) more effectively than standard care alone. Standard care includes regular cleaning, dressings, and compression bandaging. The trial also evaluates the safety of the TR987 gel. Individuals with a venous leg ulcer for at least four weeks, measuring between 2 cm² and 12 cm², may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

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, 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 shows that the TR987 0.1% gel is generally safe to use. Studies have found that products like TR987, which contain beta glucan, are safe for treating ulcers caused by poor blood flow in the legs. In previous studies, most patients used the gel without many side effects.

Since TR987 is in a Phase 3 trial, much is already known about its safety. By this stage, earlier trials have usually demonstrated the treatment's safety. Phase 3 trials primarily focus on confirming the safety and effectiveness of a treatment with a larger group of people. This indicates strong evidence that the gel is well-tolerated by humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Venous Leg Ulcers?

Researchers are excited about TR987 0.1% gel for venous leg ulcers because it offers a novel approach to healing. Unlike the standard care options, which typically involve wound cleansing, dressings, and compression bandaging, TR987 introduces a new active ingredient in a topical gel form. This gel is designed to enhance healing when used alongside the usual care methods. Its unique formulation might accelerate wound closure and improve recovery time, providing a potentially more effective solution for patients suffering from these chronic ulcers.

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

Research has shown that TR987 0.1% gel, one of the treatments in this trial, may aid in healing Venous Leg Ulcers (VLUs) when combined with standard care. Participants will receive either standard care alone or the TR987 gel with standard care. Studies have confirmed that TR987 is safe and effective, particularly in healing ulcers caused by poor blood flow in the veins. The gel activates certain cells in the body that repair tissue and fight infection. Previous trials demonstrated that TR987 significantly improves skin quality and accelerates healing compared to treatments without active ingredients. These findings suggest that TR987 could be a valuable addition to standard wound care for individuals with VLUs. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Venous Leg Ulcers, which are non-healing wounds typically caused by poor blood circulation in the legs. Participants should have an ulcer that hasn't healed and must be able to follow the study's procedures.

Inclusion Criteria

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

I have been diagnosed with venous insufficiency.

My blood flow in arteries is confirmed to be adequate.

Exclusion Criteria

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.

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

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

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TR987 0.1% gel

Trial Overview The trial is testing if a gel called TR987 at a concentration of 0.1%, when used alongside standard wound care practices, can better heal Venous Leg Ulcers compared to just the usual wound care methods 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

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.

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

Compression therapy remains the primary treatment for venous leg ulcers (VLUs), but adjunctive pharmacological agents can enhance healing, particularly micronized purified flavonoid fraction, pentoxifylline, sulodexide, and mesoglycan.

This literature review highlights the importance of combining pharmacological treatments with compression therapy to improve patient outcomes, quality of life, and potentially reduce healthcare costs associated with VLUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Literature Review of Pharmacological Agents to Improve Venous Leg Ulcer Healing. Kitchens, BP., Snyder, RJ., Cuffy, CA.[2021]

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]

In a study involving 16 patients with 26 venous leg ulcers, the combination of a triple compression bandage and chitosan gel resulted in an impressive 89% reduction in ulcer area over nine weeks, averaging a healing rate of 1.8 cm² per week.

This treatment approach showed better healing outcomes compared to traditional compression bandage therapy alone, suggesting that chitosan gel may enhance the effectiveness of standard ulcer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of chitosan may improve the treatment efficacy of triple bandage and compression in the treatment of venous leg ulcers. Sandoval, M., Albornoz, C., Muñoz, S., et al.[2011]

In a pilot study involving 148 patients with diabetic or venous ulcers, a topical ointment containing multivalent silver oxide significantly improved ulcer healing compared to standard treatment, with complete closure rates of 42% for venous ulcers and 39% for diabetic ulcers versus 22% and 16% in control groups, respectively.

The silver oxide ointment also enhanced microcirculation, evidenced by a greater increase in skin oxygen levels and flux, indicating its potential as an effective adjunct therapy for difficult-to-heal ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venous and diabetic ulcerations: management with topical multivalent silver oxide ointment. Belcaro, G., Cesarone, MR., Errichi, BM., et al.[2012]

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. 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. ... Venous ...

3. 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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06707090

NCT06707090 | Tissue Repair Gel in Venous Leg Ulcers ... 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. 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 ...