Reconstruction of Ankle and Foot Defects
Primary Purpose
Foot Injury
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
medial plantar artery flap
Distally based sural artery flap
Sponsored by
About this trial
This is an interventional treatment trial for Foot Injury
Eligibility Criteria
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 .
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1 : medial plantar artery flap
group 2 : distally based sural artery flap
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967040
Brief Title
Reconstruction of Ankle and Foot Defects
Official Title
A Comparative Study Between Distally Based Sural Artery Flap and Medial Plantar Artery Flap in Reconstruction of Ankle and Foot Defects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1 : medial plantar artery flap
Arm Type
Active Comparator
Arm Title
group 2 : distally based sural artery flap
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
medial plantar artery flap
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Distally based sural artery flap
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference in functional outcome between group 1 and group 2
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
27930679
Citation
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.
Results Reference
background
PubMed Identifier
22789482
Citation
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.
Results Reference
background
PubMed Identifier
17640813
Citation
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.
Results Reference
background
Learn more about this trial
Reconstruction of Ankle and Foot Defects
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