An interventional study of Reversed Pedicled Peroneal Artery Flap in Soft Tissue Injuries, Leg Injuries and Foot Injuries, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
64 studies on the registry are indexed under Soft Tissue Injuries; 7 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 51 interventional studies indexed under Soft Tissue Injuries.
Browse Soft Tissue Injuries studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with soft tissue defects of the distal leg, ankle, heel, or foot underwent reconstruction using a reversed pedicled peroneal artery fasciocutaneous flap augmented by the superficial sural artery. The flap was designed along the axis of peroneal artery perforators, elevated in a subfascial plane, and rotated 180° to cover the defect. The pivot point was placed 5-7 cm above the tip of the lateral malleolus. The donor site was closed primarily or with a split-thickness skin graft. Post-operative care included limb elevation and immobilization for 3-4 weeks.
Procedure: 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 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.
Number of Participants with Complete Flap Survival
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.
Time frame: 6 weeks post-operatively
Number of Participants with Post-Operative Complications
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.
Time frame: 6 weeks post-operatively
No study locations are listed for this record.
Start is estimated for Apr 2026; primary completion for Apr 2027, 12 months later.
Of 18 interventional studies with no phase under Soft Tissue Injuries, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 12 months is above that.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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