NCT07453199

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026May 2027

First Submitted

Initial submission to the registry

February 19, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 19, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

Reverse Peroneal Artery FlapSoft Tissue ReconstructionDistal Leg DefectSuperficial Sural ArteryPedicled FlapReconstructive Surgery

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

EXPERIMENTAL

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

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.

Reversed Peroneal Artery Flap Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Soft Tissue InjuriesLeg InjuriesFoot InjuriesAnkle Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

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