Recruiting
Phase 3

Tissue Repair Gel

Sponsor:

TR Therapeutics

Code:

NCT06707103

Conditions

Venous Leg Ulcer

Venous Ulcer

Venous Stasis Ulcer

Venous Stasis

Wound Heal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TR987 0.1% gel + Standard of Care

Standard of care

Study Details

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.

Conditions

Venous Leg Ulcer

Venous Ulcer

Venous Stasis Ulcer

Venous Stasis

Wound Heal

Study ID

NCT06707103

Start date

Apr, 2025

Status verified date

Mar, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • History of cancer in the preceding 5 years (except as noted in the protocol).
  • Participants considered nutritionally deficient.

Study Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TR987 0.1% gel + Standard of Care

Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.

other: Standard of Care

Participants will receive Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.

Interventions

TR987 0.1% gel + Standard of Care

6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)

Standard of care

Standard of Care (wound cleansing/dressings and compression bandaging)

Primary outcome measure

  • Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit. [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Anhthu Nguyen Vice President, Global Clinical Operations

(+61) 280 034 554anhthu.nguyen@trtherapeutics.com

Locations

Clincial Research Site 92

Recruiting

Jacksonville, Florida, United States, 32256

Clincial Research Site 77

Recruiting

Clinton Twp, Michigan, United States, 48038

Clinical Research Site 76

Recruiting

Fort Worth, Texas, United States, 76104

More Information

Sponsor

TR Therapeutics

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Keywords

  • Tissue Repair
  • Glucoprime
  • TR Therapeutics
  • Debridement
  • VLU

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TR Therapeutics on 2025-04-02.