Tissue Repair Gel in Venous Leg Ulcers in AU/US
Recruiting now · Phase 3
Conditions studied: Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wound, Venous Insufficiency of Leg, Non-healing Wound
In brief
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.
Key facts
- Study ID
- NCT06707103
- Run by
- TR Therapeutics
- People needed
- 312
- Starts
- 2025-04-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2025-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%.
You may not qualify if…
- 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.
Where it is running
- Clinical Research Site 76 — Fort Worth, Texas, United States (enrolling)
- Clincial Research Site 77 — Clinton Twp, Michigan, United States (enrolling)
- Clincial Research Site 60 — Ivanhoe, Victoria, Australia (enrolling)
- Clincial Research Site 65 — Shepparton, Victoria, Australia (enrolling)
- Clincial Research Site 92 — Jacksonville, Florida, United States (enrolling)
- Clincial Research Site 85 — Sydney, New South Wales, Australia
- Clincial Research Site 74 — Bendigo, Victoria, Australia
- Clincial Research Site 75 — Nedlands, Western Australia, Australia
- Clincial Research Site 82 — Lake Success, New York, United States
- Clincial Research Site 62 — Camperdown, New South Wales, Australia
- Clinical Research Site 84 — Kogarah, New South Wales, Australia
- Clincial Research Site 78 — Orange, New South Wales, Australia
Full record on ClinicalTrials.gov
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