Resurfacing of Foot and Distal Leg Soft Tissue Defects Using Reversed Pedicled Peroneal Artery Flaps Augmented by Superficial Sural Artery
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for not_applicable
Started Apr 2026
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
March 5, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 5, 2026
February 1, 2026
1 year
February 19, 2026
February 27, 2026
Conditions
Keywords
Outcome Measures
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.
6 weeks post-operatively
Secondary Outcomes (1)
Number of Participants with Post-Operative Complications
6 weeks post-operatively
Study Arms (1)
Reversed Peroneal Artery Flap Group
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at Orthopaedic & Trauma Department, Assiut University
Study Record Dates
First Submitted
February 19, 2026
First Posted
March 5, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 5, 2026
Record last verified: 2026-02