Soft Tissue InjuriesNCT07453199
Resurfacing of Foot and Distal Leg Soft Tissue Defects Using Reversed Pedicled Peroneal Artery Flaps Augmented by Superficial Sural Artery
A study testing Reversed Pedicled Peroneal Artery Flap in people with Soft Tissue Injuries and Leg Injuries, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Injuries, Leg Injuries, Foot Injuries
- What is being tested?
- Reversed Pedicled Peroneal Artery Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Soft Tissue Injuries, Leg Injuries, Foot Injuries, Ankle Injuries
- Being tested
- Reversed Pedicled Peroneal Artery Flap
- Keywords
- Reverse Peroneal Artery Flap, Soft Tissue Reconstruction, Distal Leg Defect, Superficial Sural Artery, Pedicled Flap, Reconstructive Surgery
- Medical subject headings
- Soft Tissue Injuries, Leg Injuries, Foot Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversed Pedicled Peroneal Artery FlapProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Reversed Pedicled Peroneal Artery Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gelan Raif Hassan Nafady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453199
- Sponsor's protocol ID
- Reversed Peroneal Artery Flap
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resurfacing of Foot and Distal Leg Soft Tissue Defects Using Reversed Pedicled Peroneal Artery Flaps Augmented by Superficial Sural Artery: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07453199
- Acronym / sponsor ID
- Reversed Peroneal Artery Flap
- Conditions
- Soft Tissue Injuries, Leg Injuries, Foot Injuries, Ankle Injuries
- Keywords
- Reverse Peroneal Artery Flap, Soft Tissue Reconstruction, Distal Leg Defect, Superficial Sural Artery, Pedicled Flap, Reconstructive Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reversed Peroneal Artery Flap Group | Experimental | Procedure: Reversed Pedicled Peroneal Artery FlapPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reversed Pedicled Peroneal Artery FlapA 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. | Procedure or surgery | Reversed Peroneal Artery Flap Group |
Primary outcome
Number of Participants with Complete Flap Survival
Time frame: 6 weeks post-operatively
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.
1 secondary outcome
Number of Participants with Post-Operative Complications
Time frame: 6 weeks post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Related trials for Soft Tissue Injuries
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Recruiting
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infections
Recruiting
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Necrotizing Fascitis, Necrotizing Soft Tissue Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reversed Pedicled Peroneal Artery Flap in people with Soft Tissue Injuries and Leg Injuries, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Complete Flap Survival (time frame: 6 weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.