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NCT Number: NCT07453199

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Reversed Pedicled Peroneal Artery Flap

Procedure

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 arteries. The donor site is closed primarily or with a split-thickness skin graft (STSG). Post-operative care includes limb elevation and immobilization in a plaster of Paris splint for 3-4 weeks.

Primary outcomes

  1. Number of Participants with Complete Flap Survival

    Time frame: 6 weeks post-operatively

    The number of participants whose reversed pedicled peroneal artery flap survives completely without total necrosis, requiring no further surgical coverage. Assessed via clinical examination of flap viability.

Secondary outcomes

  1. Number of Participants with Post-Operative Complications

    Time frame: 6 weeks post-operatively

    The number of participants who develop at least one of the following post-operative complications following flap surgery: venous congestion, partial or total flap necrosis, wound infection, or dehiscence. Assessed via clinical examination.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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