Resurfacing of Foot and Distal Leg Soft Tissue Defects Using Reversed Pedicled Peroneal Artery Flaps Augmented by Superficial Sural Artery

Официальное название

Resurfacing of Foot and Distal Leg Soft Tissue Defects Using Reversed Pedicled Peroneal Artery Flaps Augmented by Superficial Sural Artery: A Prospective Clinical Trial

Обзор

Wounds involving the skin and soft tissue of the lower leg, ankle, heel, and foot can be difficult to treat because there is very little skin and tissue available in that area to cover the wound. When the wound is large or involves exposed bone or tendon, a flap, which is a piece of skin and tissue moved from a nearby area, is needed to close it. This study evaluates a surgical technique called the Reversed Peroneal Artery Flap (RPAF). In this procedure, a flap of skin and tissue from the outer side of the lower leg is lifted and rotated to cover the wound. The blood supply to the flap comes from the peroneal artery, which runs along the fibula bone, and is augmented by the superficial sural artery to improve flap survival. The study will include 30 adult patients who have soft tissue defects of the distal leg, ankle, heel, or foot. All patients will undergo the RPAF procedure at Assiut University Hospitals, Egypt. The main goal is to measure how well the flap survives after surgery. Secondary goals include assessing complications, functional recovery, and the condition of the donor site.

Подробное описание

Soft tissue defects of the distal leg, ankle, and foot present a significant reconstructive challenge due to the limited availability of local soft tissue, the critical functional requirements of the area, and the high risk of complications such as osteomyelitis and unstable scarring. Traditional reconstructive options include local flaps, skin grafts, cross-leg flaps, and free tissue transfer. While free flaps offer robust coverage, they require specialized microvascular expertise, prolonged operative time, and are not suitable for all patients, particularly those with significant comorbidities or in resource-limited settings. The Reverse Peroneal Artery Flap (RPAF) is a distally-based fasciocutaneous or perforator-based flap supplied by the peroneal artery. Its survival relies on retrograde blood flow through anastomoses between the peroneal artery and the anterior and posterior tibial arteries around the ankle joint. Augmentation with the superficial sural artery has been proposed to further enhance flap perfusion and reliability. Pre-operative assessment includes clinical examination of the defect and peripheral pulses, Doppler ultrasonography to confirm patency of the anterior and posterior tibial arteries and to identify peroneal artery perforators, and plain X-rays to rule out osteomyelitis. CT angiography may be used in selected complex cases. The flap is designed along the axis of the peroneal artery perforators with the pivot point 5-7 cm above the tip of the lateral malleolus. The flap size is designed 1-2 cm larger than the defect. Elevation proceeds in a subfascial plane from proximal to distal, with ligation of the peroneal artery proximal to the most proximal perforator included. The flap is then rotated 180° to cover the defect. The donor site is closed primarily or with a split-thickness skin graft (STSG). Post-operative care includes limb elevation, close monitoring for venous congestion, and immobilization in a plaster of Paris splint for 3-4 weeks.

Вмешательства

• Процедура Reversed Pedicled Peroneal Artery Flap
  A distally-based fasciocutaneous flap supplied by the peroneal artery, augmented by the superficial sural artery, used for reconstruction of soft tissue defects of the distal leg, ankle, heel, and foot. The flap is designed along the peroneal artery perforators, elevated in a subfascial plane, and rotated 180° around a pivot point 5-7 cm above the lateral malleolus. Flap survival relies on retrograde blood flow through anastomoses between the peroneal artery and the anterior and posterior tibial

Первичные конечные точки

• Number of Participants with Complete Flap Survival [Срок оценки: 6 weeks post-operatively]

Вторичные конечные точки (1)

• Number of Participants with Post-Operative Complications [Срок оценки: 6 weeks post-operatively]

Критерии участия

Критерии включения

• Patients with soft tissue defects of the distal third of the leg, ankle, heel, or foot requiring flap coverage.
• Defect size greater than \[Specify size, e.g., 5x5 cm\] or involving exposed bone, tendon, or joint.
• Palpable pulse in at least one of the major vessels Anterior Tibial Artery (ATA) or Posterior Tibial Artery (PTA)) at the ankle level.
• Informed consent obtained from the patient or legal guardian

Критерии исключения

• Patients with peripheral vascular disease (PVD) or diabetes mellitus (DM) or smokers
• Comminuted fractures of the tibia \& fibula
• Patients requiring free flap coverage for massive defects or location beyond the RPAF's reach as the planter aspect of the foot

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07453199 · Reversed Peroneal Artery Flap

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗