Trauma Patients With Soft Tissue DefectsNCT06885892
Posterior Tibial Artery Perforator-Pedicled Propeller Flaps in Reconstruction
A study testing Posterior Tibial Artery Perforator-Pedicled Propeller Flaps and Perforator-Pedicled Propeller Flaps in people with Trauma Patients With Soft Tissue Defects, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Trauma Patients With Soft Tissue Defects
- What is being tested?
- Posterior Tibial Artery Perforator-Pedicled Propeller Flaps and Perforator-Pedicled Propeller Flaps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 28 Feb 2021
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.age range :10-80years. 2. in good overall heath without severe comorbidities. 3. posterior perforator tibial artery is no damage.
Who cannot join
- age range <10years or >80years.
- with severe comorbidities
- Posterior perforator tibial artery of panticipants is damage
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma Patients With Soft Tissue Defects
- Being tested
- Posterior Tibial Artery Perforator-Pedicled Propeller Flaps, Perforator-Pedicled Propeller Flaps
- Keywords
- the lower leg, soft tissue defects, perforator flaps, propeller flaps, doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Tibial Artery Perforator-Pedicled Propeller FlapsProcedure or surgery
Posterior tibial artery perforator-pedicled propeller flaps are feasible, safe, and effective procedure in the reconstruction of the defects in the lower leg.
Perforator-Pedicled Propeller FlapsProcedure or surgery
Posterior Tibial Artery Perforator-Pedicled Propeller Flaps
| Study group | Role | What they receive |
|---|---|---|
| surgery | Experimental | posterior tibial artery perforator-pedicled propeller flaps transplantation for soft-tissue defects Receives: Procedure: Posterior Tibial Artery Perforator-Pedicled Propeller Flaps; Procedure: Perforator-Pedicled Propeller Flaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
flaps observation
flaps color :normal;pale;cyanoderma
Measured: 12-24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Jan 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trauma Patients With Soft Tissue DefectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885892
- Sponsor's protocol ID
- XYFY2015-JS018-01
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32123981Jakubietz 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.
PubMed 18046150
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Tibial Artery Perforator-Pedicled Propeller Flaps for Reconstruction of the Defects in the Lower Leg（Case Series）
- ClinicalTrials.gov ID
- NCT06885892
- Acronym / sponsor ID
- XYFY2015-JS018-01
- Conditions
- Trauma Patients With Soft Tissue Defects
- Keywords
- the lower leg, soft tissue defects, perforator flaps, propeller flaps, doppler ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 20 Mar 2025 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Experimental | Procedure: Posterior Tibial Artery Perforator-Pedicled Propeller Flaps, Procedure: Perforator-Pedicled Propeller Flapsposterior tibial artery perforator-pedicled propeller flaps transplantation for soft-tissue defects |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1.age range :10-80years. 2. in good overall heath without severe comorbidities. 3. posterior perforator tibial artery is no damage.
Key exclusion criteria (3 listed)
- age range <10years or >80years.
- with severe comorbidities
- Posterior perforator tibial artery of panticipants is damage
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 |
|---|---|---|
| Posterior Tibial Artery Perforator-Pedicled Propeller FlapsPosterior tibial artery perforator-pedicled propeller flaps are feasible, safe, and effective procedure in the reconstruction of the defects in the lower leg. | Procedure or surgery | surgery |
| Perforator-Pedicled Propeller FlapsPosterior Tibial Artery Perforator-Pedicled Propeller Flaps | Procedure or surgery | surgery |
Primary outcome
flaps observation
Time frame: 12-24months
flaps color :normal;pale;cyanoderma
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 20 Mar 2025.
- Results publication: PubMed 32123981Lin 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.
- Results publication: PubMed 18046150Jakubietz 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.
- Individual participant dataSharing planned: No
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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 Posterior Tibial Artery Perforator-Pedicled Propeller Flaps and Perforator-Pedicled Propeller Flaps in people with Trauma Patients With Soft Tissue Defects, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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 3 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 20 Mar 2025. 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 China. 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?
flaps observation (time frame: 12-24months). 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 NCT06885892, which also lists 2 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 20 Mar 2025.