New gel treatment for venous leg ulcers
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)
This study is testing a new gel treatment for people with stubborn venous leg ulcers to see if it helps them heal better than just the usual care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TR Therapeutics Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 12 sites (Jacksonville, Florida and 11 other locations) |
| Trial ID | NCT06707103 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of TR987 0.1% gel combined with Standard of Care compared to Standard of Care alone in treating non-healing Venous Leg Ulcers (VLUs). It is a randomized, double-blind, multicenter study lasting 16 weeks, focusing on the complete closure of the target ulcer. Secondary endpoints include pain level changes and ulcer area reduction over the treatment period. The study aims to provide insights into both the efficacy and safety of the gel treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinically diagnosed venous insufficiency and a non-healing venous ulcer between 2 cm² and 12 cm².
Not a fit: Patients with a history of certain treatments or conditions affecting the target ulcer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for patients with venous leg ulcers.
How similar studies have performed: Other studies have shown promise in using similar topical treatments for wound healing, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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%. Exclusion Criteria: * 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. * History of cancer in the preceding 5 years (except as noted in the protocol). * Participants considered nutritionally deficient.
Where this trial is running
Jacksonville, Florida and 11 other locations
- Clincial Research Site 92 — Jacksonville, Florida, United States (Recruiting)
- Clincial Research Site 77 — Clinton Twp, Michigan, United States (Recruiting)
- Clincial Research Site 82 — Lake Success, New York, United States (Not_yet_recruiting)
- Clinical Research Site 76 — Fort Worth, Texas, United States (Recruiting)
- Clincial Research Site 62 — Camperdown, New South Wales, Australia (Not_yet_recruiting)
- Clinical Research Site 84 — Kogarah, New South Wales, Australia (Not_yet_recruiting)
- Clincial Research Site 78 — Orange, New South Wales, Australia (Not_yet_recruiting)
- Clincial Research Site 85 — Sydney, New South Wales, Australia (Not_yet_recruiting)
- Clincial Research Site 74 — Bendigo, Victoria, Australia (Not_yet_recruiting)
- Clincial Research Site 60 — Ivanhoe, Victoria, Australia (Recruiting)
- Clincial Research Site 65 — Shepparton, Victoria, Australia (Recruiting)
- Clincial Research Site 75 — Nedlands, Western Australia, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Anhthu Nguyen Vice President, Global Clinical Operations
- Email: anhthu.nguyen@trtherapeutics.com
- Phone: (+61) 280 034 554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.