Clinical trial NCT06707090: Tissue Repair Gel in Venous Leg Ulcers (US)
Official title: A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Venous Leg Ulcer
Venous Ulcer
Venous Stasis Ulcer
Venous Stasis
Wound Heal
Wounds
Venous Insufficiency of Leg
Non-healing Wound
Keywords: Tissue Repair
Glucoprime
TR Therapeutics
Debridement
VLU
Lead sponsor: TR Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.
* History of cancer in the preceding 5 years (except as noted in the protocol).
* Participants considered nutritionally deficient.

Primary outcomes:
measure: Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
timeFrame: 16 weeks
Secondary outcomes:
measure: 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)
timeFrame: 16 weeks
measure: Change from baseline in participant's perception of pain level at 12 weeks.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 and 16 weeks
measure: Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
timeFrame: 12 weeks
measure: Proportion of participants with any significant reduction in pain at or before 12 weeks.
timeFrame: 12 weeks
measure: Proportion of target ulcers which reach greater than 70% closure at 12 weeks and 16 weeks
timeFrame: 12 and 16 weeks
measure: Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks
timeFrame: 12 and 16 weeks
measure: Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks
timeFrame: 12 and 16 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Clincial Research Site 21
state: Arizona
city: Castro Valley
country: United States
facility: Clincial Research Site 43C
state: California
city: Fresno
country: United States
facility: Clincial Research Site 14
state: California
city: Los Angeles
country: United States
facility: Clincial Research Site 11
state: California
city: San Francisco
country: United States
facility: Clincial Research Site 43A
state: California
city: San Francisco
country: United States
facility: Clincial Research Site 43B
state: California
city: Deerfield Beach
country: United States
facility: Clincial Research Site 47
state: Florida
city: Hollywood
country: United States
facility: Clincial Research Site 38
state: Florida
city: Jacksonville
country: United States
facility: Clincial Research Site 40
state: Florida
city: Tamarac
country: United States
facility: Clincial Research Site 51
state: Florida
city: Springfield
country: United States
facility: Clincial Research Site 49
state: Illinois
city: Winston Salem
country: United States
facility: Clincial Research Site 55
state: North Carolina
city: Grove City
country: United States
facility: Clincial Research Site 45
state: Ohio
city: Mentor
country: United States
facility: Clincial Research Site 23
state: Ohio
city: Tulsa
country: United States
facility: Clincial Research Site 28
state: Oklahoma
city: Fort Worth
country: United States
facility: Clincial Research Site 24
state: Texas
city: Houston
country: United States
facility: Clincial Research Site 32
state: Texas
city: San Antonio
country: United States
facility: Clincial Research Site 46
state: Texas
city: Suffolk
country: United States
facility: Clincial Research Site 18
state: Virginia
Study officials:
References: