NCT06885892

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

March 9, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

the lower legsoft tissue defectsperforator flapspropeller flapsdoppler ultrasound

Outcome Measures

Primary Outcomes (1)

  • flaps observation

    flaps color :normal;pale;cyanoderma

    12-24months

Study Arms (1)

surgery

EXPERIMENTAL

posterior tibial artery perforator-pedicled propeller flaps transplantation for soft-tissue defects

Procedure: Posterior Tibial Artery Perforator-Pedicled Propeller FlapsProcedure: Perforator-Pedicled Propeller Flaps

Interventions

Posterior tibial artery perforator-pedicled propeller flaps are feasible, safe, and effective procedure in the reconstruction of the defects in the lower leg.

surgery

Posterior Tibial Artery Perforator-Pedicled Propeller Flaps

surgery

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age range :10-80years. 2. in good overall heath without severe comorbidities. 3. posterior perforator tibial artery is no damage.

You may not qualify if:

  • age range \<10years or \>80years.
  • with severe comorbidities
  • Posterior perforator tibial artery of panticipants is damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Related Publications (2)

  • 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.

    PMID: 32123981BACKGROUND
  • 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.

    PMID: 18046150BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 20, 2025

Study Start

January 1, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations