Reconstruction of Ankle and Foot Defects

A Comparative Study Between Distally Based Sural Artery Flap and Medial Plantar Artery Flap in Reconstruction of Ankle and Foot Defects

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Foot Injury
• Intervention / Treatment: Procedure: medial plantar artery flap; Procedure: Distally based sural artery flap

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 : medial plantar artery flap	Procedure: medial 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
Active Comparator: group 2 : distally based sural artery flap	Procedure: Distally 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Difference in functional outcome between group 1 and group 2 is measured at 4 months postoperative

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 15, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Foot Injuries
• Other Study ID Numbers: Soh-Med-21-07-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No