Vascular Surgery Trial
Dear Colleague, I am an investigator for the BG003 TRIVIA study. This study is evaluating the safety and efficacy of TR-987® 0.1% gel in conjunction with Standard of Care versus Standard of Care alone in healing Venous Leg Ulcers (VLUs). In this study Standard of Care is wound cleansing with saline and removal of necrotic tissue and compression bandaging. The study is currently enrolling, and we are looking for participant referrals. Research into the mechanism of action indicates that the active ingredient in TR987® 0.1% gel activates an immune response that leads to accelerated wound closure. To qualify for the TRIVIA study participants must meet the following criteria: Key Inclusion/Exclusion Criteria: 1. Male or female aged 18 or older. 2. Has a clinical diagnosis of Venous Insufficiency. 3. Has a venous stasis leg ulcer with an ulcer area a minimum of 2 cm2. 4. Does not have Peripheral Artery Disease with an arterial flow ≥ 0.8 or similar 5. Less than 50% of the ulcer extends below the malleolus. 6. BMI ≤ 42 kg/m2 7. HbA1C ≤12% Endocrinology trials For patients with obesity or diabetes who are at their treatment threshold or unable to access/afford current therapies, considering a clinical trial may be a good option. Please follow this link Active Clinical Trials Information or use the below QR code to see whether your patient is interested and don’t hesitate to reach out to clinical trial coordinators.
Additional criteria apply. Approximately 312 people will take part in this study. Participants will be in the study up to 30 weeks and visit the study site up to 26 times. Participants will be randomised 1 to 1 to receive either TR-987® 0.1% gel with Standard of Care or Standard of Care alone. Please be assured that participants will be returned to your care at the conclusion of the study. Likewise, our team can keep you informed of your patient’s status during the study (with permission). I appreciate your consideration and welcome the chance to discuss the TRIVIA study with you. To learn more about this study, or to refer a patient, please contact me at NSLHD-vascularsurgeryresearch@ health.nsw.gov.au or (02) 9463 1767. Sincerely, Dr Vikram Puttaswamy HoD RNSH
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GPLink | October 2025
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