The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage
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: Cerament G, Standard Surgical Managment.
- Кому может быть актуально
- Состояния в реестре: Osteomyelitis, Diabetes, Calcanectomy. 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
- Ирландия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Randomised Controlled Trial Comparing Partial Calcanectomy Plus Local Application Antibiotic Impregnated Bone Graft Substitute for Calcaneal Osteomyelitis vs Partial Calcanectomy Alone (The ACHILLS Trial)
Обзор
The ACHILLS Trial is a multicentre randomised controlled feasibility study comparing partial calcanectomy with and without the use of an antibiotic-impregnated bone graft substitute (Cerament G) for treating calcaneal osteomyelitis, specifically on wound healing rates, re-infection, and overall efficacy in a sample of 30 patients over a one-year period.
Подробное описание
Calcaneal osteomyelitis is a severe infection of the heel bone, frequently linked to peripheral arterial disease and diabetes, which complicates the healing process. This condition can lead to chronic wounds, persistent pain, and, in extreme cases, the need for limb amputation. Standard treatment often involves partial or total calcanectomy, where the infected bone is surgically removed, significantly impacting patients' mobility and quality of life.
The ACHILLS Trial is a multicentre, randomised controlled feasibility study designed to assess the efficacy of partial calcanectomy with and without the use of Cerament G, an antibiotic-impregnated bone graft substitute.
The primary objective is to determine the rate of wound healing in patients undergoing partial calcanectomy for osteomyelitis who receive Cerament G.
Secondary objectives include assessing time to wound healing, rates of re-infection, hospital stay duration, need for extended antibiotic therapy, financial impact, and overall quality of life.
The trial will involve 30 participants, aged 18 and older, undergoing partial calcanectomy for osteomyelitis. Participants will be randomly assigned to one of two groups: one receiving partial calcanectomy with Cerament G, and the other receiving partial calcanectomy alone with standard antibiotic therapy. The study will monitor patients for one year, with data collected at multiple intervals to monitor wound healing, re-infection rates, and other outcomes.
Cerament G, comprising calcium sulphate and hydroxyapatite, serves as a bone substitute and delivers a localised antibiotic (gentamycin) directly to the infection site. This approach aims to reduce infection rates, promote bone healing, and minimise the need for further surgical interventions.
The results from this feasibility study may result in a larger trial, potentially leading to improved management strategies for calcaneal osteomyelitis, reduced healthcare costs, and enhanced patient outcomes.
Вмешательства
- Устройство Cerament G
Partial Calcanectomy plus cerament G - Другое Standard Surgical Managment
Partial Calcanectomy as standard of care
Первичные конечные точки
- Rate of Wound Healing [Срок оценки: 1 months post-surgery]
- Rate of Wound Healing [Срок оценки: 3 months post-surgery]
- Rate of Wound Healing [Срок оценки: 6 months post-surgery]
- Rate of Wound Healing [Срок оценки: 12 months post-surgery]
Вторичные конечные точки (7)
- Time to Wound Healing [Срок оценки: 1, 3, 6, and 12 months post-surgery]
- Quality of life measured with the EQ5D5L (Health Questionnaire) [Срок оценки: 1 month post-surgery]
- Quality of life measured with the EQ5D5L (Health Questionnaire) [Срок оценки: 3 months post-surgery]
- Quality of life measured with the EQ5D5L (Health Questionnaire) [Срок оценки: 6 months post-surgery]
- Quality of life measured with the EQ5D5L (Health Questionnaire) [Срок оценки: 12 months post-surgery]
- Cost to Patients Questionaire (CoPaQ) [Срок оценки: 12 months post-surgery]
- Length of Hospital Stay [Срок оценки: 12 months post-surgery]
Критерии участия
Критерии включения
- 18 and over
- Undergoing partial calcanectomy
- Patients with Type1 or Type 2 Diabetes
- Patients will be stratified by Pulse status and eGFR
Критерии исключения
- Patients unfit for surgery
- Patients unable to provide informed consent
- Patients with overwhelming sepsis that require major amputation
- Patients with hypersensitivity to aminoglycosides
- Pre-existing calcium metabolism disorder
- Severe renal impairment
- Patients in whom major limb amputation is deemed inevitable by the treating physician
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Ирландия · 1 центр
- University Hospital Galway — Galway
Идентификаторы
NCT: NCT07057817 · RCSI-ACHILLS