Open Wound of Lower LimbNCT05027542
Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects
An observational study of Open Wound of Lower Limb, run by Abeer Musaddiq at 1 site in Pakistan.
Trial summary
Our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle. The patients' information were collected through medical records and analyzed through SPSS Read more about this study
- Who is it for?
- Ages 2 months to 74 years
- Conditions the study is for
- Open Wound of Lower Limb
- How many people
- 53 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2020to 15 Mar 2021
- Phase
- Observational
- 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 2 months to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data of all those patients was collected who underwent reconstruction of soft tissue defects of foot and ankle with Supramalleolar and sural artery flaps between 1996 and 2020. The data of these patients were collected from the Hospital inpatient management system and review of medical records through a structured proforma that included demographic variables, cause of soft tissue defects (secondary to open fractures, following debridement of chronic infected wounds, tumor excision and defects following release of scar contractures), side of defects, size and type of flap (supramalleolar or sural artery), complications and long-term outcome of the flap.
Who may be able to join
- Only defects of foot and ankle around dorsum and perimalleolar areas were included.
Who cannot join
- The defects reconstructed with other local flaps and free flaps were excluded from this review
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects; A CROSS-SECTIONAL STUDY OF 53 PATIENTS
Our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle. The patients' information were collected through medical records and analyzed through SPSS
Read the detailed description
In this article we intend to present our experience comparing a series of the two types of flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot and ankle based on self-designed Tool . This Tool contains 4 parameters i.e., Activity of daily living, coverage of defect, cosmetic appearance of Skin post flap, and Weight bearing status. A score was given to each parameter and on the basis of these scores, Long term outcome were analyzed of each patient
- Conditions
- Open Wound of Lower Limb
- Keywords
- Soft Tissue Injuries, fasciocutaneous flaps, Survival Rate
- Medical subject headings
- Soft Tissue Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
self-designed assessment tool
The functional outcome of each patient was measured by activity of daily living
Measured: 1996-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Nov 2020
- Primary completion30 Jan 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Wound of Lower LimbStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abeer Musaddiq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abeer Musaddiq, Aga Khan University Hospital, Pakistan
- Investigators
- Pervaiz Hashmi, Principal investigator, Agha Khan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027542
- Sponsor's protocol ID
- 4452
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data of study participants is only accessible to researcher of this study
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects; A CROSS-SECTIONAL STUDY OF 53 PATIENTS
- ClinicalTrials.gov ID
- NCT05027542
- Acronym / sponsor ID
- 4452
- Conditions
- Open Wound of Lower Limb
- Keywords
- Soft Tissue Injuries, fasciocutaneous flaps, Survival Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Abeer MusaddiqUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 30 Aug 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.
Our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle. The patients' information were collected through medical records and analyzed through SPSS
Detailed description
In this article we intend to present our experience comparing a series of the two types of flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot and ankle based on self-designed Tool . This Tool contains 4 parameters i.e., Activity of daily living, coverage of defect, cosmetic appearance of Skin post flap, and Weight bearing status. A score was given to each parameter and on the basis of these scores, Long term outcome were analyzed of each patient
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 months to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data of all those patients was collected who underwent reconstruction of soft tissue defects of foot and ankle with Supramalleolar and sural artery flaps between 1996 and 2020. The data of these patients were collected from the Hospital inpatient management system and review of medical records through a structured proforma that included demographic variables, cause of soft tissue defects (secondary to open fractures, following debridement of chronic infected wounds, tumor excision and defects following release of scar contractures), side of defects, size and type of flap (supramalleolar or sural artery), complications and long-term outcome of the flap.
Key inclusion criteria (1 listed)
- Only defects of foot and ankle around dorsum and perimalleolar areas were included.
Key exclusion criteria (1 listed)
- The defects reconstructed with other local flaps and free flaps were excluded from this review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
self-designed assessment tool
Time frame: 1996-2020
The functional outcome of each patient was measured by activity of daily living
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No. data of study participants is only accessible to researcher of this study
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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.
Pervaiz Hashmi principal investigator
Agha Khan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Wound of Lower Limb, run by Abeer Musaddiq at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 30 Aug 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
self-designed assessment tool (time frame: 1996-2020). 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 30 Aug 2021.