Tissue Repair Gel in Venous Leg Ulcers (US)
Launched by TR THERAPEUTICS · Nov 24, 2024
Trial Information
Current as of July 24, 2025
Recruiting
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.
About Tr Therapeutics
TR Therapeutics is a dedicated clinical trial sponsor focused on advancing innovative therapeutic solutions to improve patient outcomes. With a commitment to rigorous research and development, TR Therapeutics specializes in the discovery and clinical evaluation of novel treatments across various therapeutic areas. The organization collaborates with leading healthcare professionals and institutions to ensure the highest standards of clinical practice and regulatory compliance. Through its patient-centric approach, TR Therapeutics aims to address unmet medical needs and contribute to the evolution of healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tucson, Arizona, United States
Fresno, California, United States
Los Angeles, California, United States
Deerfield Beach, Florida, United States
Jacksonville, Florida, United States
Tamarac, Florida, United States
Springfield, Illinois, United States
Winston Salem, North Carolina, United States
Grove City, Ohio, United States
Mentor, Ohio, United States
Tulsa, Oklahoma, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Suffolk, Virginia, United States
Castro Valley, California, United States
San Francisco, California, United States
San Francisco, California, United States
Hollywood, Florida, United States
San Antonio, Texas, United States
Miami, Florida, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported