Tissue Repair Gel in Venous Leg Ulcers (US)

Recruiting now · Phase 3

Conditions studied: Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wounds, 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

NCT06707090

Run by

TR Therapeutics

People needed

312

Starts

2025-01-28

Expected to finish

2028-02-01

Last updated by the study team

2026-02-12

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.
• Participants considered nutritionally deficient.

Where it is running

• Clincial Research Site 26 — Miami, Florida, United States (enrolling)
• Clincial Research Site 43C — Castro Valley, California, United States (enrolling)
• Clincial Research Site 14 — Fresno, California, United States (enrolling)
• Clincial Research Site 11 — Los Angeles, California, United States (enrolling)
• Clincial Research Site 43A — San Francisco, California, United States (enrolling)
• Clincial Research Site 43B — San Francisco, California, United States (enrolling)
• Clincial Research Site 54 — Vista, California, United States (enrolling)
• Clincial Research Site 40 — Jacksonville, Florida, United States (enrolling)
• Clincial Research Site 19 — Miami, Florida, United States (enrolling)
• Clincial Research Site 13 — Pembrook Pines, Florida, United States (enrolling)
• Clincial Research Site 34 — Chicago, Illinois, United States (enrolling)
• Clincial Research Site 10 — O'Fallon, Illinois, United States (enrolling)
• Clincial Research Site 49 — Springfield, Illinois, United States (enrolling)
• Clincial Research Site 04 — Bossier City, Louisiana, United States (enrolling)
• Clincial Research Site 01 — Lafayette, Louisiana, United States (enrolling)
• Clincial Research Site 07 — D'Iberville, Mississippi, United States (enrolling)
• Clincial Research Site 02 — McComb, Mississippi, United States (enrolling)
• Clincial Research Site 30 — New York, New York, United States (enrolling)
• Clincial Research Site 37 — Syosset, New York, United States (enrolling)
• Clincial Research Site 28 — Tulsa, Oklahoma, United States (enrolling)
• Clincial Research Site 36 — Philadelphia, Pennsylvania, United States (enrolling)
• Clincial Research Site 24 — Fort Worth, Texas, United States (enrolling)
• Clincial Research Site 32 — Houston, Texas, United States (enrolling)
• Clincial Research Site 18 — Suffolk, Virginia, United States (enrolling)
• Clincial Research Site 51 — Tamarac, Florida, United States

Full record on ClinicalTrials.gov

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