Foot InjuryNCT04967040
Reconstruction of Ankle and Foot Defects
A study testing medial plantar artery flap and Distally based sural artery flap in people with Foot Injury, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Foot Injury
- What is being tested?
- medial plantar artery flap and Distally based sural artery flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aging 5 to 70 years. Defect at the foot and ankle. Defect size (5- 15) cm2.
Who cannot join
- Severe infection. Unhealthy skin of posterior or lateral aspect of leg . Defect more than 15 cm . Injury to vascular pedicle of the aimed flap .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Foot Injury
- Being tested
- medial plantar artery flap, Distally based sural artery flap
- Medical subject headings
- Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial plantar artery flapProcedure or surgery
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
Distally based sural artery flapProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| group 1 : medial plantar artery flap | Active comparator | Not described Receives: Procedure: medial plantar artery flap |
| group 2 : distally based sural artery flap | Active comparator | Not described Receives: Procedure: Distally based sural artery flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Difference in functional outcome between group 1 and group 2 is measured at 4 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jan 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Foot InjuryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Shereef, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967040
- Sponsor's protocol ID
- Soh-Med-21-07-11
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 27930679Hamdi 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 22789482Uygur 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Distally Based Sural Artery Flap and Medial Plantar Artery Flap in Reconstruction of Ankle and Foot Defects
- ClinicalTrials.gov ID
- NCT04967040
- Acronym / sponsor ID
- Soh-Med-21-07-11
- Conditions
- Foot Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 19 Jul 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 : medial plantar artery flap | Active comparator | Procedure: medial plantar artery flap |
| group 2 : distally based sural artery flap | Active comparator | Procedure: Distally based sural artery flap |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aging 5 to 70 years. Defect at the foot and ankle. Defect size (5- 15) cm2.
Key exclusion criteria (1 listed)
- Severe infection. Unhealthy skin of posterior or lateral aspect of leg . Defect more than 15 cm . Injury to vascular pedicle of the aimed flap .
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 |
|---|---|---|
| medial plantar artery flapMedial 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 | Procedure or surgery | group 1 : medial plantar artery flap |
| Distally based sural artery flapDistally 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 | Procedure or surgery | group 2 : distally based sural artery flap |
Primary outcome
Difference in functional outcome between group 1 and group 2
Time frame: Difference in functional outcome between group 1 and group 2 is measured at 4 months postoperative
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Background: PubMed 27930679Li 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.
- Background: PubMed 22789482Hamdi 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.
- Background: PubMed 17640813Uygur 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medial plantar artery flap and Distally based sural artery flap in people with Foot Injury, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Difference in functional outcome between group 1 and group 2 (time frame: Difference in functional outcome between group 1 and group 2 is measured at 4 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967040, which also lists 3 linked publications.
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 19 Jul 2021.