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

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.

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.

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 therapies and oral pharmacological agents. While other treatments often focus on oral medications or compression, TR987 Gel provides a direct application to the ulcer site, which may enhance healing. ^{1 2 3 4 5}

Eligibility Criteria

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 ulcer has been present for at least 4 weeks.

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

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

Treatment Details

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.

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

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+

Findings from Research

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 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]

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 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]

References

1. 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]

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. United States pubmed.ncbi.nlm.nih.gov

A Literature Review of Pharmacological Agents to Improve Venous Leg Ulcer Healing. [2021]

4. United States 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. [2011]

5. Italy pubmed.ncbi.nlm.nih.gov

Venous and diabetic ulcerations: management with topical multivalent silver oxide ointment. [2012]