Tissue Repair Gel in Venous Leg Ulcers in AU/US

NCT06707103 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BG003
• Study Type: interventional
• Target: 312
• Locations: 2 countries
• Sites: 12

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; Wound; Venous Insufficiency of Leg; Non-healing Wound

Keywords

Tissue Repair; Glucoprime; TR Therapeutics; Debridement; VLU

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.

  Patient count

  16 weeks

Secondary Outcomes (5)

• Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).

  16 weeks

• Change from baseline in participant's perception of pain level at 12 weeks.

  12 weeks

• Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.

  12 and 16 weeks

• Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.

  12 weeks

• Proportion of participants with any significant reduction in pain at or before 12 weeks.

  12 weeks

Study Arms (2)

TR987 0.1% gel + Standard of Care

EXPERIMENTAL

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.

Drug: TR987 0.1% gel + Standard of Care

Standard of Care

OTHER

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.

Other: Standard of care

Interventions

TR987 0.1% gel + Standard of Care DRUG

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

Also known as: Glucoprime

TR987 0.1% gel + Standard of Care

Standard of care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• TR Therapeutics: lead

Study Sites (12)

Clincial Research Site 92

Jacksonville, Florida, 32256, United States

RECRUITING

Clincial Research Site 77

Clinton Twp, Michigan, 48038, United States

RECRUITING

Clincial Research Site 82

Lake Success, New York, 11042, United States

NOT YET RECRUITING

Clinical Research Site 76

Fort Worth, Texas, 76104, United States

RECRUITING

Clincial Research Site 62

Camperdown, New South Wales, 2050, Australia

NOT YET RECRUITING

Clinical Research Site 84

Kogarah, New South Wales, 2217, Australia

NOT YET RECRUITING

Clincial Research Site 78

Orange, New South Wales, 2800, Australia

NOT YET RECRUITING

Clincial Research Site 85

Sydney, New South Wales, 2065, Australia

NOT YET RECRUITING

Clincial Research Site 74

Bendigo, Victoria, 3550, Australia

NOT YET RECRUITING

Clincial Research Site 60

Ivanhoe, Victoria, 3079, Australia

RECRUITING

Clincial Research Site 65

Shepparton, Victoria, 3630, Australia

RECRUITING

Clincial Research Site 75

Nedlands, Western Australia, 6009, Australia

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Varicose Ulcer; Wounds and Injuries

Interventions

Gels; Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Anhthu Nguyen Vice President, Global Clinical Operations

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Particpants will be randomized to either TR987 1% gel + Standard of Care and Standard of Care alone. Sponsor, particpant, and Investigator/Outcomes Assessor will be masked throughout the treatment period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); AU (8)