Tissue Repair Gel in Venous Leg Ulcers in AU/US

Launched by TR THERAPEUTICS · Nov 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TR987 0.1% gel to see if it works better than standard care alone for healing venous leg ulcers (VLUs). These ulcers can be painful and difficult to heal, often caused by poor blood flow in the legs. The researchers want to find out not only how effective this gel is in helping the ulcers heal but also if it is safe for patients to use.

To participate in this trial, you need to be an adult aged 18 or older with a diagnosed venous insufficiency, meaning your veins have trouble moving blood back to your heart. The ulcer you have should be between 2 and 12 square centimeters and must have been present for at least four weeks. Participants will receive either the TR987 gel along with standard care or just standard care alone. If you're interested, it’s important to know that certain health conditions and treatments may prevent you from joining, so a screening will help determine your eligibility. Overall, this trial aims to improve treatment options for those suffering from venous leg ulcers.

Gender

ALL

Eligibility 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.