Tissue Repair Gel in Venous Leg Ulcers in AU/US
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TR987 0.1% gel + Standard of Care, Standard of care.
- Who it may be relevant to
- Registry conditions: Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
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.
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.
Interventions
- Drug TR987 0.1% gel + Standard of Care
6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging) - Other Standard of care
Standard of Care (wound cleansing/dressings and compression bandaging)
Primary outcome measures
- Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit. [Time frame: 16 weeks]
Secondary outcome measures (5)
- 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). [Time frame: 16 weeks]
- Change from baseline in participant's perception of pain level at 12 weeks. [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. [Time frame: 12 and 16 weeks]
- Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit. [Time frame: 12 weeks]
- Proportion of participants with any significant reduction in pain at or before 12 weeks. [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 8 centers
- Clincial Research Site 62 — Camperdown
- Clinical Research Site 84 — Kogarah
- Clincial Research Site 78 — Orange
- Clincial Research Site 85 — Sydney
- Clincial Research Site 74 — Bendigo
- Clincial Research Site 60 — Ivanhoe
- Clincial Research Site 65 — Shepparton
- Clincial Research Site 75 — Nedlands
United States · 4 centers
- Clincial Research Site 92 — Jacksonville
- Clincial Research Site 77 — Clinton Twp
- Clincial Research Site 82 — Lake Success
- Clinical Research Site 76 — Fort Worth
Identifiers
NCT: NCT06707103 · BG003