Идёт набор NCT06707090

Tissue Repair Gel in Venous Leg Ulcers (US)

Фаза III С лечением Venous Leg Ulcer Venous Ulcer Venous Stasis Ulcer Venous Stasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: TR987 0.1% gel + Standard of Care, Standard of care.
Кому может быть актуально: Состояния в реестре: Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат TR987 0.1% gel + Standard of Care
6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
Другое Standard of care
Standard of Care (wound cleansing/dressings and compression bandaging)

Первичные конечные точки

Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit. [Срок оценки: 16 weeks]

Вторичные конечные точки (8)

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) [Срок оценки: 16 weeks]
Change from baseline in participant's perception of pain level at 12 weeks. [Срок оценки: 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. [Срок оценки: 12 and 16 weeks]
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit. [Срок оценки: 12 weeks]
Proportion of participants with any significant reduction in pain at or before 12 weeks. [Срок оценки: 12 weeks]
Proportion of target ulcers which reach greater than 70% closure at 12 weeks and 16 weeks [Срок оценки: 12 and 16 weeks]
Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks [Срок оценки: 12 and 16 weeks]
Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks [Срок оценки: 12 and 16 weeks]

Критерии участия

Критерии включения

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%.