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Tissue Repair Gel in Venous Leg Ulcers in AU/US

PHASE3RECRUITING

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.

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Study 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). The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.

Secondary endpoints include:. * 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). * Change from baseline in participant's perception of pain level at 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. * Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.

* Proportion of participants with any significant reduction in pain at or before 12 weeks. There are also some supplementary and safety endpoints.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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, or TCPo2.

Body mass index (BMI) ≤ 42 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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-11-01

Primary completion: 2026-12-01

Study completion finish: 2027-02-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06707103

Intervention or treatment

DRUG: TR987 0.1% gel

OTHER: Standard of care

Conditions

• Venous Leg Ulcer
• Venous Ulcer
• Venous Stasis Ulcer
• Venous Stasis
• Wound Heal
• Wound
• Venous Insufficiency of Leg
• Non-healing Wound

Condition: Venous Leg Ulcer, Venous Ulcer and more
DRUG: TR987 0.1% gel and other drugs
Orange, New South Wales, Australia and more
Sponsor: TR Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Clincial Research Site 78

Research sites nearby

Select from list below to view details:

Clincial Research Site 78
Orange, New South Wales, Australia
Clincial Research Site 85
Sydney, New South Wales, Australia
Clincial Research Site 60
Ivanhoe, Victoria, Australia
Clincial Research Site 65
Shepparton, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.	DRUG: TR987 0.1% gel 6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
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.	OTHER: Standard of care Standard of Care (wound cleansing/dressings and compression bandaging)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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).	Patient count	16 weeks
Change from baseline in participant's perception of pain level at 12 weeks.	Pain to be measured on a 10 point numeric rating scale	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.	Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change	12 and 16 weeks
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.	Count the number of patients with complete closure and divide by the total number of patients	12 weeks
Proportion of participants with any significant reduction in pain at or before 12 weeks.	Count the number of patients with any significant reduction in pain and divide by the total number of patients	12 weeks

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Tissue Repair Gel in Venous Leg Ulcers in AU/US