Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing
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: Topical Tetrachlorodecaoxide (TCDO/Oxoferin), Standard Wound Care.
- Кому может быть актуально
- Состояния в реестре: Chronic Wound Care. 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
- Пакистан
- 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
Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing: Insights From a Randomized Controlled Trial
Обзор
This is a single-center, randomized controlled trial evaluating the effectiveness of topical tetrachlorodecaoxide (TCDO) solution in enhancing chronic wound healing. The study will compare standard wound care with and without the addition of topical TCDO drops. Eligible adult participants with chronic wounds of more than six weeks' duration will be randomly assigned to either the intervention or control group. The trial aims to assess the rate of wound healing, time to 50% wound closure, pain reduction measured by the Visual Analog Scale (VAS), and cost-effectiveness.
Подробное описание
Chronic wounds-including diabetic foot ulcers, arterial ulcers, venous leg ulcers, and pressure ulcers-represent a major clinical and economic burden in low-resource settings. Delayed healing increases the risk of infection, amputation, and prolonged hospitalization. Various topical agents have been used to enhance healing, with variable success. Tetrachlorodecaoxide (TCDO), a solution with antimicrobial and oxygen-releasing properties, has shown promising results in promoting granulation tissue. However, local clinical evidence is limited.
This randomized controlled trial aims to evaluate the effectiveness of topical tetrachlorodecaoxide (TCDO) in promoting chronic wound healing, compared to standard wound care alone. A total of 66 participants with chronic wounds (duration ≥ 6 weeks) will be enrolled in the Department of General Surgery, MTI Khyber Teaching Hospital (MTI-KTH), Peshawar. Participants will be randomly assigned to one of two groups: an intervention group receiving standard wound care plus topical TCDO application, or a control group receiving standard wound care alone. TCDO will be applied once daily (OD) for up to three weeks. Patients will be followed for up to 12 weeks to assess healing progress.
The primary outcome will be the percentage reduction in wound area, measured using the simple ruler method. Secondary outcomes include time to 50% wound closure, change in pain score using the Visual Analog Scale (VAS), wound Quality of Life (QoL) scores, and a cost-effectiveness analysis. Safety outcomes will be monitored throughout the study.
Ethical approval will be obtained from the MTI-KTH Institutional Review Board (IRB). The study will be conducted free of cost to participants and may offer an affordable treatment alternative to improve chronic wound care in resource-limited settings.
Вмешательства
- Препарат Topical Tetrachlorodecaoxide (TCDO/Oxoferin)
Topical Tetrachlorodecaoxide (TCDO), a solution with antimicrobial and oxygen-releasing properties, will be applied once daily to the wound bed for 21 consecutive days or until satisfactory healing. - Другое Standard Wound Care
Standard wound care includes saline irrigation, wound debridement, antibiotic administration as necessary, and sterile dressing. Provided to all participants.
Первичные конечные точки
- Change in wound area (cm²) [Срок оценки: Baseline to 4 weeks]
Вторичные конечные точки (5)
- Time to 50% wound closure [Срок оценки: Baseline to 12 weeks]
- Change in pain score (Visual Analog Scale, VAS) [Срок оценки: Baseline to 12 weeks]
- Incidence of wound infection [Срок оценки: Baseline to 12 weeks]
- Cost-Effectiveness of TCDO Treatment [Срок оценки: Base line to 12 weeks]
- Change in wound-related quality of life (Wound-QoL) score [Срок оценки: Base line to 12 weeks]
Критерии участия
Критерии включения
- Adults > 18 years diagnosed with chronic wounds (duration > 6 weeks)
- Wound size between 5 and 10 cm²
- Adequate perfusion:
- Ankle-Brachial Pressure Index (ABPI) > 0.8 for venous leg ulcers
- Palpable pulses for diabetic foot ulcers
Критерии исключения
- Patients receiving immunosuppressive therapy or corticosteroids
- Presence of malignancy
- Patients who do not provide informed consent
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
Пакистан · 1 центр
- Khyber Teaching Hospital, MTI KTH Peshawar — Peshawar
Публикации
- Parikh R, Bakhshi G, Naik M, Gaikwad B, Jadhav K, Tayade M. The Efficacy and Safety of Tetrachlorodecaoxide in Comparison with Super-oxidised Solution in Wound Healing. Arch Plast Surg. 2016 Sep;43(5):395-401. doi: 10.5999/aps.2016.43.5.395. Epub 2016 Sep 21. PMID 27689045
Идентификаторы
NCT: NCT07096830 · KTH-RCT-TCDO-WOUND-2025-01