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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Reversed Pedicled Peroneal Artery Flap

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Reversed Peroneal Artery Flap GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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