Recruiting

Phase 3

Tissue Repair GelTissue Repair Gel in Venous Leg Ulcers (US)

Sponsor:

TR Therapeutics

Code:

NCT06707090

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

NCT06707090

Start date

Jan 28, 2025

Status verified date

Sep, 2025

Completion date

Feb, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

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.
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

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) 280 034 554 anhthu.nguyen@trtherapeutics.com

Locations

Clincial Research Site 43C

Recruiting

Castro Valley, California, United States, 94546

Contacts

Tissue Repair GelTissue Repair Gel in Venous Leg Ulcers (US)

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information