CClinicalTrials.gg
Status unknownNCT04967040Updated Jul 19, 2021

Reconstruction of Ankle and Foot Defects

An interventional study of medial plantar artery flap and Distally based sural artery flap in Foot Injury, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 5 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-19.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2020, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
5 Years to 70 Years
Sex
All
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Study summary

Reconstruction of soft tissue defects around the foot and ankle region is a challenging problem for reconstructive surgeons due to the lack of locally available tissues for transposition, the relatively poor skin circulation, and the special structural characteristics of this area, bones and tendons can easily become exposed due to trauma. so foot injuries are often associated with a loss of soft tissues and exposed bones . The plantar skin is thick, with solid anchorage to the deep structures. Therefore, the reconstructive aim is to restore the stability of the foot skin to adapt to weightbearing and to resist shearing forces. In addition, good sensibility should be considered in the reconstruction. Additional considerations the ankle region has great tension during movement, and good stability is required for shoes wearing. The medial plantar flap has been effectively used in the reconstruction of soft tissue defects localized to the plantar foot, forefoot, posterior heel, and ankle in small to medium sized defects . This flap can be transferred to the defect as a proximally or distally pedicled island flap . The distally based sural artery flap frequently used for reconstruction of soft tissue defects of the lower leg, foot and ankle in medium and large sized defects .Fascio-cutaneous flaps are highly effective and easy to perform.

This study is a comparative study designed for assessment of the clinical applications of distally based sural flap versus medial plantar artery flap regarding the size of the defect , operative technique and their outcomes (success and complications) as a reconstructive option for foot and ankle defects.

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Conditions studied

  • Foot Injury

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03

In context

Foot Injuries

51 studies on the registry are indexed under Foot Injuries; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 52 across 38 interventional studies indexed under Foot Injuries.

Browse Foot Injuries studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients aging 5 to 70 years. Defect at the foot and ankle. Defect size (5- 15) cm2.

Exclusion criteria

Exclusion Criteria:

Severe infection. Unhealthy skin of posterior or lateral aspect of leg . Defect more than 15 cm . Injury to vascular pedicle of the aimed flap .

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    group 1 : medial plantar artery flap

    Procedure: medial plantar artery flap

  • Active comparator
    group 2 : distally based sural artery flap

    Procedure: Distally based sural artery flap

Interventions

  • Proceduremedial plantar artery flap

    Medial plantar artery flap is a fasciocutaneous island flap raised from the non-weightbearing instep of the plantar foot. The dominant vascular pedicle of the flap consists of the medial plantar artery and venae comitantes

  • ProcedureDistally based sural artery flap

    Distally based sural artery flap is a fascio-cutaneous island flap taken from the posterior aspect of the middle third of the leg and fed by the lower peroneal septo-cutaneous perforators in reverse fashion. Its vascular basis is the close association between the median superficial sural artery and peroneal artery perforators

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What researchers measure

Primary outcomes

  1. Difference in functional outcome between group 1 and group 2

    The functional outcomes are graded as excellent, good, and poor. The criteria for excellent results are the survival of the flap without any flap loss and walking without any aids . Survival of the flap with minimum complications and walking with aids are the criteria for good results. A result is considered poor when an alternative reconstructive procedure is considered

    Time frame: Difference in functional outcome between group 1 and group 2 is measured at 4 months postoperative

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Study locations

1 site
  • Sohag University Hospital
    Sohag, Egypt
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References and documents

Publications

  • Li X, Cui J, Maharjan S, Lu L, Gong X. Reconstruction of the Foot and Ankle Using Pedicled or Free Flaps: Perioperative Flap Survival Analysis. PLoS One. 2016 Dec 8;11(12):e0167827. doi: 10.1371/journal.pone.0167827. eCollection 2016. PubMed 27930679 ↗
  • Hamdi MF, Kalti O, Khelifi A. Experience with the distally based sural flap: a review of 25 cases. J Foot Ankle Surg. 2012 Sep-Oct;51(5):627-31. doi: 10.1053/j.jfas.2012.05.029. Epub 2012 Jul 11. PubMed 22789482 ↗
  • Uygur F, Duman H, Ulkur E, Noyan N, Celikoz B. Reconstruction of distal forefoot burn defect with retrograde medial plantar flap. Burns. 2008 Mar;34(2):262-7. doi: 10.1016/j.burns.2007.02.010. Epub 2007 Jul 20. PubMed 17640813 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04967040
Lead sponsor
Sohag University
Responsible party
Ahmed Mohamed Shereef (principal investigator, Sohag University) — Principal investigator
First posted
Jul 19, 2021
Start date
Jan 1, 2020
Primary completion
Dec 1, 2021 (estimated)
Completion
Jan 15, 2022 (estimated)
Last update
Jul 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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