Tissue Repair Gel in Venous Leg Ulcers (US)

Phase 3

Recruiting

• Conditions: Venous Leg Ulcer; Venous Ulcer; Venous Stasis Ulcer; Venous Stasis; Wound Heal; Wounds; Venous Insufficiency of Leg; Non-healing Wound
• Interventions: Drug: TR987 0.1% gel + Standard of Care; Other: Standard of care

• Registration Number: NCT06707090
• Lead Sponsor: TR Therapeutics

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-12
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

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%.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TR987 0.1% gel + Standard of Care	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.
Standard of Care	Standard of care	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.	16 weeks	Patient count

Secondary Outcome Measures

Name	Time	Method
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	Patient count
Change from baseline in participant's perception of pain level at 12 weeks.	12 weeks	Pain to be measured on a 10 point numeric rating scale
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	Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.	12 weeks	Count the number of patients with complete closure and divide by the total number of patients
Proportion of participants with any significant reduction in pain at or before 12 weeks.	12 weeks	Count the number of patients with any significant reduction in pain and divide by the total number of patients
Proportion of target ulcers which reach greater than 70% closure at 12 weeks and 16 weeks	12 and 16 weeks	Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be \>70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)
Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks	12 and 16 weeks	Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be \>70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)
Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks	12 and 16 weeks	Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be \>70% closed at 12 or 16-weeks, respectively, for purposes of this analysis)

Trial Locations

Locations (14)

Clincial Research Site 21; 🇺🇸 Tucson, Arizona, United States

Clincial Research Site 14; 🇺🇸 Fresno, California, United States

Clincial Research Site 11; 🇺🇸 Los Angeles, California, United States

Clincial Research Site 47; 🇺🇸 Deerfield Beach, Florida, United States

Clincial Research Site 40; 🇺🇸 Jacksonville, Florida, United States

Clincial Research Site 51; 🇺🇸 Tamarac, Florida, United States

Clincial Research Site 49; 🇺🇸 Springfield, Illinois, United States

Clincial Research Site 55; 🇺🇸 Winston Salem, North Carolina, United States

Clincial Research Site 45; 🇺🇸 Grove City, Ohio, United States

Clincial Research Site 23; 🇺🇸 Mentor, Ohio, United States

Clincial Research Site 28; 🇺🇸 Tulsa, Oklahoma, United States

Clincial Research Site 24; 🇺🇸 Fort Worth, Texas, United States

Clincial Research Site 32; 🇺🇸 Houston, Texas, United States

Clincial Research Site 18; 🇺🇸 Suffolk, Virginia, United States