Tissue Repair Gel in Venous Leg Ulcers (US)

Phase 3RecruitingNCT06707090

TR Therapeutics312 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

312

Conditions

Venous Leg Ulcer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (33)

Clincial Research Site 21

Tucson, Arizona, United States

ACTIVE_NOT_RECRUITING

Clincial Research Site 43C

Castro Valley, California, United States

RECRUITING

Clincial Research Site 14

Fresno, California, United States

RECRUITING

Clincial Research Site 11

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Patient count

Time frame: 16 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Proportion of target ulcers which reach greater than 70% closure at 12 weeks 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)

Time frame: 12 and 16 weeks

Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks

Time frame: 12 and 16 weeks

Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks

Time frame: 12 and 16 weeks

Tissue Repair Gel in Venous Leg Ulcers (US)

Overview

Conditions

Interventions

Eligibility

Locations (33)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts