- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278836
Fasciocutaneous Flaps for Leg Defects
January 26, 2011 updated by: Isfahan University of Medical Sciences
Study of Fasciocutaneous Flaps for Treatment of Leg Defects
The purpose of this study is to determine the effects of fasciocutaneous flaps for leg defects.
Study Overview
Detailed Description
The fasciocutaneous flaps are tissue flaps which include skin, subcutaneous tissue, and the underlying fascia.
Including the deep fascia with its prefascial and subfascial plexus enhances the circulation of these flaps.
The investigators determined long-term outcomes of fasciocutaneous flap reconstruction in patients with lower limb defects.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Isfahan, Iran, Islamic Republic of
- Kashani University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with leg defects
Exclusion Criteria:
- patients with underlying diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: fascio-cutaneous flap
flaps which include skin, subcutaneous tissue, and the underlying fascia.
|
flaps which include skin, subcutaneous tissue, and the underlying fascia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
necrosis
Time Frame: at three years after surgery
|
at three years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
venous congestion
Time Frame: at three years after surgery
|
at three years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
January 27, 2011
Last Update Submitted That Met QC Criteria
January 26, 2011
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ASD-1213-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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