- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06885892
Posterior Tibial Artery Perforator-Pedicled Propeller Flaps in Reconstruction
March 13, 2025 updated by: The Affiliated Hospital of Xuzhou Medical University
Posterior Tibial Artery Perforator-Pedicled Propeller Flaps for Reconstruction of the Defects in the Lower Leg(Case Series)
Soft tissue defects in the lower leg remain a challenge for surgeons due to frequent bone exposure and paucity of soft tissues.
The goal in this study was to evaluate the surgical technique and clinical significance of posterior tibial artery perforator-pedicled propeller flaps for reconstruction of defects in the lower leg.
Study Overview
Status
Completed
Conditions
Detailed Description
The construction of the lower extremity defects with exposed bone and tendon is considered as the biggest challenge of all body regions in many plastic and reconstructive surgeons.
The lower leg regions are in visible areas.
Defects recovery and aesthetic consideration should be considered at the same time with the development of the economy and society.
Although free flaps have been used to reconstruct these defects, some disadvantages still exist, such as needing microinstruments, long operation time and none like-with-like repair.
In this article, a series of patients with soft tissue defects in the lower leg were transplanted with posterior tibial artery perforator-pedicled propeller flaps.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
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
-
-
Jiangsu
-
Xuzhou, Jiangsu, China, 221000
- The Affiliated Hospital of Xuzhou Medical University
-
-
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
No
Description
Inclusion Criteria:
- 1.age range :10-80years. 2. in good overall heath without severe comorbidities. 3. posterior perforator tibial artery is no damage.
Exclusion Criteria:
- age range <10years or >80years.
- with severe comorbidities
- Posterior perforator tibial artery of panticipants is damage
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: surgery
posterior tibial artery perforator-pedicled propeller flaps transplantation for soft-tissue defects
|
Posterior tibial artery perforator-pedicled propeller flaps are feasible, safe, and effective procedure in the reconstruction of the defects in the lower leg.
Posterior Tibial Artery Perforator-Pedicled Propeller Flaps
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
flaps observation
Time Frame: 12-24months
|
flaps color :normal;pale;cyanoderma
|
12-24months
|
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.
General Publications
- Lin J, Zhou F, Sun YD, Gao YS, Li HZ, Zheng HP, Zhang YF, Li QF, Ward PJ, Yang YL, Liu CY. Modified Anterior Tibial Artery Perforator-Pedicled Propeller Flap for Soft-Tissue Coverage of the Ankle and Heel. World J Surg. 2020 Jul;44(7):2237-2242. doi: 10.1007/s00268-020-05452-y.
- Jakubietz RG, Jakubietz MG, Gruenert JG, Kloss DF. The 180-degree perforator-based propeller flap for soft tissue coverage of the distal, lower extremity: a new method to achieve reliable coverage of the distal lower extremity with a local, fasciocutaneous perforator flap. Ann Plast Surg. 2007 Dec;59(6):667-71. doi: 10.1097/SAP.0b013e31803c9b66.
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 (Actual)
January 1, 2019
Primary Completion (Actual)
February 28, 2021
Study Completion (Actual)
February 28, 2021
Study Registration Dates
First Submitted
March 9, 2025
First Submitted That Met QC Criteria
March 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- XYFY2015-JS018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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