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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leg Injuries; Soft Tissue Injuries; Ankle Injuries; Foot Injuries
• Intervention / Treatment: Procedure: Reversed Pedicled Peroneal Artery Flap

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Reversed Peroneal Artery Flap Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks post-operatively

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Reconstructive Surgery; Pedicled Flap; Reverse Peroneal Artery Flap; Soft Tissue Reconstruction; Distal Leg Defect; Superficial Sural Artery
• Additional Relevant MeSH Terms: Wounds and Injuries; Ankle Injuries; Leg Injuries; Soft Tissue Injuries; Foot Injuries
• Other Study ID Numbers: Reversed Peroneal Artery Flap

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No