Tissue Repair Gel in Venous Leg Ulcers (US)
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.
| Condition(s) | Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wounds, Venous Insufficiency of Leg, Non-healing Wound |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | TR Therapeutics |
| Locations | Tucson, Arizona, United States; Castro Valley, California, United States; Fresno, California, United States; Los Angeles, California, United States; San Francisco, California, United States; San Francisco, California, United States (+27 more sites) |
| Start date | 2025-01-28 |
| NCT ID | NCT06707090 |
| Official listing | https://clinicaltrials.gov/study/NCT06707090 |