Tissue Repair Gel in Venous Leg Ulcers (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 helps heal venous leg ulcers (VLUs) better than the standard care alone. Venous leg ulcers are wounds that can develop on the legs due to poor blood flow, and they can be difficult to heal. The trial aims to find out if using the gel along with standard care is more effective and safe for patients.

To participate in the trial, people need to be at least 18 years old and have a venous ulcer that has been present for at least 4 weeks and is between 2 and 12 square centimeters in size. They also need to have good blood flow to the area and meet certain health criteria, like having a body mass index (BMI) of 42 or less. If someone joins the trial, they can expect to receive the gel treatment along with regular care for their ulcer, and their progress will be carefully monitored. This study is currently recruiting participants, and it’s essential to understand that not everyone may qualify due to specific health conditions or treatments they may have received in the past.

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.