Clinical trial NCT06707103: Tissue Repair Gel in Venous Leg Ulcers in AU/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
Wound
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
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Clincial Research Site 92
state: Florida
city: Clinton Twp
country: United States
facility: Clincial Research Site 77
state: Michigan
city: Lake Success
country: United States
facility: Clincial Research Site 82
state: New York
city: Fort Worth
country: United States
facility: Clinical Research Site 76
state: Texas
city: Camperdown
country: Australia
facility: Clincial Research Site 62
state: New South Wales
city: Kogarah
country: Australia
facility: Clinical Research Site 84
state: New South Wales
city: Orange
country: Australia
facility: Clincial Research Site 78
state: New South Wales
city: Sydney
country: Australia
facility: Clincial Research Site 85
state: New South Wales
city: Bendigo
country: Australia
facility: Clincial Research Site 74
state: Victoria
city: Ivanhoe
country: Australia
facility: Clincial Research Site 60
state: Victoria
city: Shepparton
country: Australia
facility: Clincial Research Site 65
state: Victoria
city: Nedlands
country: Australia
facility: Clincial Research Site 75
state: Western Australia
Study officials:
References: