Tissue Repair Gel for treating Venous Leg Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate 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 objectives include assessing pain levels and changes in ulcer area over time. The study will also monitor the safety of the TR987 gel throughout the treatment period.

Why it matters

Who can join: the full rules

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.
* Participants considered nutritionally deficient.

Where it's running

• Clincial Research Site 43C
  Castro Valley, California, United States Recruiting
• Clincial Research Site 14
  Fresno, California, United States Recruiting
• Clincial Research Site 11
  Los Angeles, California, United States Recruiting
• Clincial Research Site 43A
  San Francisco, California, United States Recruiting
• Clincial Research Site 43B
  San Francisco, California, United States Recruiting
• Clincial Research Site 54
  Vista, California, United States Recruiting

Study contacts

• Study coordinator: Anhthu Nguyen Vice President, Global Clinical Operations
• Email: anhthu.nguyen@trtherapeutics.com
• Phone: (+61) 280 034 554

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.