Tissue Repair Gel in Venous Leg Ulcers (US)

NCT06707090 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BG002
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 33

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

Wound Heal; Non-healing Wound; Venous Leg Ulcer; Venous Ulcer; Venous Stasis Ulcer; Venous Stasis; Wounds; Venous Insufficiency of Leg

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 (8)

• 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

Other: Standard of care

Interventions

Standard of care OTHER

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

Standard of Care

TR987 0.1% gel + Standard of Care DRUG

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

TR987 0.1% gel + 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.
• Participants considered nutritionally deficient.

Sponsors & Collaborators

• TR Therapeutics: lead

Study Sites (33)

Clincial Research Site 21

Tucson, Arizona, 85715, United States

ACTIVE NOT RECRUITING

Clincial Research Site 43C

Castro Valley, California, 94546, United States

RECRUITING

Clincial Research Site 14

Fresno, California, 93710, United States

RECRUITING

Clincial Research Site 11

Los Angeles, California, 90063, United States

RECRUITING

Clincial Research Site 43A

San Francisco, California, 94115, United States

RECRUITING

Clincial Research Site 43B

San Francisco, California, 94117, United States

RECRUITING

Clincial Research Site 54

Vista, California, 92081, United States

RECRUITING

Clincial Research Site 47

Deerfield Beach, Florida, 33442, United States

ACTIVE NOT RECRUITING

Clincial Research Site 38

Hollywood, Florida, 33021, United States

NOT YET RECRUITING

Clincial Research Site 40

Jacksonville, Florida, 32209, United States

RECRUITING

Clincial Research Site 19

Miami, Florida, 33150, United States

RECRUITING

Clincial Research Site 26

Miami, Florida, 33156, United States

RECRUITING

Clincial Research Site 13

Pembrook Pines, Florida, 33026, United States

RECRUITING

Clincial Research Site 51

Tamarac, Florida, 33321, United States

WITHDRAWN

Clincial Research Site 22

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Clincial Research Site 34

Chicago, Illinois, 60649, United States

RECRUITING

Clincial Research Site 10

O'Fallon, Illinois, 62269, United States

RECRUITING

Clincial Research Site 49

Springfield, Illinois, 62704, United States

RECRUITING

Clincial Research Site 04

Bossier City, Louisiana, 71111, United States

RECRUITING

Clincial Research Site 01

Lafayette, Louisiana, 70507, United States

RECRUITING

Clincial Research Site 07

D'Iberville, Mississippi, 39540, United States

RECRUITING

Clincial Research Site 02

McComb, Mississippi, 39648, United States

RECRUITING

Clincial Research Site 30

New York, New York, 10019, United States

RECRUITING

Clincial Research Site 37

Syosset, New York, 11791, United States

RECRUITING

Clincial Research Site 55

Winston-Salem, North Carolina, 27157, United States

ACTIVE NOT RECRUITING

Clincial Research Site 45

Grove City, Ohio, 43123, United States

WITHDRAWN

Clincial Research Site 23

Mentor, Ohio, 44060, United States

WITHDRAWN

Clincial Research Site 28

Tulsa, Oklahoma, 74137, United States

RECRUITING

Clincial Research Site 36

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Clincial Research Site 24

Fort Worth, Texas, 76104, United States

RECRUITING

Clincial Research Site 32

Houston, Texas, 27707, United States

RECRUITING

Clincial Research Site 46

San Antonio, Texas, 78224, United States

NOT YET RECRUITING

Clincial Research Site 18

Suffolk, Virginia, 23434, United States

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: Participants will be randomized to either TR987 1% gel + Standard of Care and Standard of Care alone. Sponsor, participant, 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: January 28, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)