NCT06707090 Tissue Repair Gel in Venous Leg Ulcers (US)
| NCT ID | NCT06707090 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | TR Therapeutics |
| Condition | Venous Leg Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2025-01-28 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 312 participants in total. It began in 2025-01-28 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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. * Participants considered nutritionally deficient.
Contact & Investigator
Anhthu Nguyen Vice President, Global Clinical Operations
✉ anhthu.nguyen@trtherapeutics.com📞 (+61) 280 034 554
Frequently Asked Questions
Who can join the NCT06707090 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Leg Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06707090 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 312 participants.
Is NCT06707090 currently recruiting?
Yes, NCT06707090 is actively recruiting participants. Contact the research team at anhthu.nguyen@trtherapeutics.com for enrollment information.
Where is the NCT06707090 trial being conducted?
This trial is being conducted at Tucson, United States, Castro Valley, United States, Fresno, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06707090 clinical trial?
NCT06707090 is sponsored by TR Therapeutics. The trial plans to enroll 312 participants.