Efficacy of Platelet-rich-Fibrin Gel in Patients With Chronic Leg Ulcers
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: Platelet rich Fibrin (PRF).
- Кому может быть актуально
- Состояния в реестре: Chronic Leg Ulcer. Базовые параметры: от 35 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
- Пакистан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Platelet rich Fibrin (PRF) gel is an emerging as a novel treatment option for chronic leg ulcers and has the potential to become the 1st line option in these conditions. The objective of our study will be to assess the efficacy of PRF gel dressing in patients with non-infective chronic leg ulcers.
Подробное описание
Chronic leg ulcers (CLU) affect approximately 1% of the adult population and the prevalence increases significantly with age. The causes of CLU are mainly non-infective and include neuropathy, venous and arterial disease followed by less common causes like metabolic and hematological disorders. Leg ulcers severely impact the patients' quality of lives and frequently result in impaired mobility and financial dependence. There are several validated tools for the objective assessment of the ulcer severity. Bates Jensen wound assessment tool (BWAT) is one of these measures which will be originally developed for assessing pressure wounds but has been validated for other wounds such as CLU. BWAT consists of 13 scored items and can be used as a comprehensive tool for initial assessment as well as an indicator of treatment response.
The management is mainly supportive and depends on the underlying aetiology but there is a dearth of targeted wound management options that promote healing. Platelet rich Fibrin (PRF) gel is an emerging as a novel treatment option for chronic leg ulcers and has the potential to become the 1st line option in these conditions . The objective of our study will be to assess the efficacy of PRF gel dressing in patients with non-infective chronic leg ulcers.
Вмешательства
- Биопрепарат Platelet rich Fibrin (PRF)
PRF is derived solely from the patient's own blood and does not contain any non-autologous additives, such as anticoagulants or bovine thrombin, as first-generation platelet concentrates (like some forms of PRP)
Первичные конечные точки
- 50% improvement in Bates Jensen wound assessment tool (BWAT) score [Срок оценки: 1 months]
Критерии участия
Критерии включения
- All male and female patients more than 35 years old with Chronic Leg Ulcers, presenting to the OPD will be included.
Критерии исключения
- Patients with clinical signs of infected ulcers, patients in sepsis and immunosuppressed individuals will be excluded.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Пакистан · 1 центр
- Pak Emirates Military Hospital — Rawalpindi
Идентификаторы
NCT: NCT07294521 · DERM112025