Ankle Tissue Injury WoundNCT04687345
Lateral Supramalleolar Perforator Flap Reconstruction Through Branches Outside of the Ankle Tissue Defects
An observational study of Ankle Tissue Injury Wound, run by National Defense Medical Center, Taiwan.
Trial summary
The lateral ankle is a common site of tissue defects and the defects in this area are often accompanied by exposure of the fibula and tendons. Microsurgical tissue transfer or a pedicled flap is needed to cover those exposures for even a relatively small defect due to the insufficiency of the local cutaneous and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ankle Tissue Injury Wound
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 12 Dec 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 10 men and 5 women aged above 20 years old. The defects are caused by diabetes mellitus (6 subjects; 3 of them also have a peripheral arterial occlusive disease), infected bursitis (1 subject), chronic osteomyelitis (2 subjects), and trauma (6 subjects). The subjects have various comorbidity, i.e. no comorbidity (N), diabetes mellitus (DM), hypertensive cardiovascular disease (HCVD), hypertension (HTN), and peripheral arterial occlusive disease (PAOD). The defect size varies from 4 cm^2 to 25 cm^2, while the flap size varies from 9 cm^2 to 80 cm^2. The defects are located at the right or left (R or L) of the lateral malleolus of the ankle and/not at the pretibial area, or at the dorsal foot below the lateral malleolus.
Who may be able to join
- The subject is aged 20 years old or above (including 20 years old), regardless of gender.
- Patients with lateral ankle tissue defects
Who cannot join
- The subject is aged under 20 years old.
- Patients with tissue metabolic disorders, immune dysfunction, and drug abuse.
- Patients with severe primary diseases or mental illness such as those involving the hematopoietic system, endocrine system, etc.
- Pregnant and lactating women.
- Patient who is unwilling or unable to cooperate with the trial process or follow medical advice.
About this study
Official title: Clinical Research of Using Lateral Supramalleolar Perforator Flap Reconstruction Through Branches Outside of the Ankle Tissue Defects
The lateral ankle is a common site of tissue defects and the defects in this area are often accompanied by exposure of the fibula and tendons. Microsurgical tissue transfer or a pedicled flap is needed to cover those exposures for even a relatively small defect due to the insufficiency of the local cutaneous and muscle flap in this area. Koshima et al. and Wei et al. began to propose the concept of localized perforator flaps, which were initially applied to free perforator flaps. The main benefits of such localized perforator flaps are described below.
- It preserves vital blood vessels and the underlying muscles and fascia.
- Complications in the donor area are rare and can be direct or partial sutures.
- Not technically demanding, although we need to find the vessel but not the vessel junction.
- Shorter surgery time.
There are many choices of perforator flaps for lateral ankle soft tissue defects, including lateral upper ankle flap, retrograde anterior tibial artery flap, retrograde gastrocnemius flap, etc. Among them, the lateral upper ankle flap is one of the flaps commonly used for reconstruction of lateral ankle tissue defects, and the research on the lateral upper peroneal artery perforator flap is limited.
Read the detailed description
The purpose of this study is to evaluate the clinical application of the peroneal artery perforator flap with or without split-thickness skin grafting for soft tissue reconstruction of the bony defect of the lateral malleolus of the ankle joints. Reconstruction using a peroneal artery perforator flap with or without split-thickness skin grafting was performed for 10 men and 5 women patients with defects in the lateral malleolus. The mean age was 53.7 years with the age range between 22 and 89 years, and the mean size of the flaps was 40 cm^2. The soft tissue defects were caused by a diabetic foot (6 patients), infected bursitis (1 patient), chronic osteomyelitis (2 patients), and trauma (6 patients). Three of six diabetes mellitus patients also had peripheral arterial occlusive disease. The flaps were elevated in the form of a perforator flap, and split-thickness skin grafting was performed over the flaps and adjoining raw areas. The pedicled supramalleolar perforator flap is classified into two categories: (A) propeller and (B) rotation flaps. The mean follow-up duration was 30 months postsurgical.
- Conditions
- Ankle Tissue Injury Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Propeller Flap | The propeller flap is based on a perforator that serves as a pivot joint, allowing the flap to rotate up to 180°. It provides the advantages of greater freedom of movement and versatility in flap design. | |
| Rotation Flap | The rotation flap is primarily supplied by the perforator artery accompanied by the random supply from the skin base. It is also associated with a lower venous congestion risk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perforator flap type
The type of the flap is categorized into propeller and rotation flap. It is determined according to the distance between the perforator and the tip of the lateral malleolus. A distance of less than 2 cm used rotation-type perforator flap, while for a distance of greater than 2 cm would use propeller-type.
Measured: 3-60 months
Flap size
The flap size is measured in the unit of cm^2. The flap size ranged from 4 cm × 3 cm to 16 cm × 6 cm.
Measured: 3-60 months
Distance between the perforator and the tip of the lateral malleolus
The distances of all perforators from the wound, which is the tip of the lateral malleolus in this study, were measured in the unit of cm. The distance ranged from 2 cm to 5 cm.
Measured: 3-60 months
Complication status
The complication status expresses the complication that occurred during the wound reconstruction. The status is stated as no complication (N) and the complication happened to the patients, such as "partial flap necrosis".
Measured: 3-60 months
Follow-up month
The follow-up month indicates the duration and the follow-up of the wound reconstruction.
Measured: 3-60 months
Donor site type
The donor site type indicates the type of skin grafting needed to be applied for covering the donor site of the patients. The donor site type in this study is divided into split-thickness skin grafting (STSG) and primary closure. The STSG was applied to 12 patients, whereas the primary closure was conducted on 3 patients.
Measured: 3-60 months
Result status
The success of the reconstruction processes is stated in the result status. All flaps and skin graftings survived which implies all wound reconstructions were successful.
Measured: 3-60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2007
- Primary completion12 Dec 2016
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle Tissue Injury WoundStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih Yu-Jen, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687345
- Sponsor's protocol ID
- PerforatorFlap2018
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hallock GG. Distal lower leg local random fasciocutaneous flaps. Plast Reconstr Surg. 1990 Aug;86(2):304-11. doi: 10.1097/00006534-199008000-00018.
PubMed 2367579Koshima I, Itoh S, Nanba Y, Tsutsui T, Takahashi Y. Medial and lateral malleolar perforator flaps for repair of defects around the ankle. Ann Plast Surg. 2003 Dec;51(6):579-83. doi: 10.1097/01.sap.0000095654.07024.65.
PubMed 14646653Wei FC, Seah CS, Tsai YC, Liu SJ, Tsai MS. Fibula osteoseptocutaneous flap for reconstruction of composite mandibular defects. Plast Reconstr Surg. 1994 Feb;93(2):294-304; discussion 305-6.
PubMed 8310021
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Using Lateral Supramalleolar Perforator Flap Reconstruction Through Branches Outside of the Ankle Tissue Defects
- ClinicalTrials.gov ID
- NCT04687345
- Acronym / sponsor ID
- PerforatorFlap2018
- Conditions
- Ankle Tissue Injury Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 29 Dec 2020 (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.
The lateral ankle is a common site of tissue defects and the defects in this area are often accompanied by exposure of the fibula and tendons. Microsurgical tissue transfer or a pedicled flap is needed to cover those exposures for even a relatively small defect due to the insufficiency of the local cutaneous and muscle flap in this area. Koshima et al. and Wei et al. began to propose the concept of localized perforator flaps, which were initially applied to free perforator flaps. The main benefits of such localized perforator flaps are described below.
- It preserves vital blood vessels and the underlying muscles and fascia.
- Complications in the donor area are rare and can be direct or partial sutures.
- Not technically demanding, although we need to find the vessel but not the vessel junction.
- Shorter surgery time.
There are many choices of perforator flaps for lateral ankle soft tissue defects, including lateral upper ankle flap, retrograde anterior tibial artery flap, retrograde gastrocnemius flap, etc. Among them, the lateral upper ankle flap is one of the flaps commonly used for reconstruction of lateral ankle tissue defects, and the research on the lateral upper peroneal artery perforator flap is limited.
Detailed description
The purpose of this study is to evaluate the clinical application of the peroneal artery perforator flap with or without split-thickness skin grafting for soft tissue reconstruction of the bony defect of the lateral malleolus of the ankle joints. Reconstruction using a peroneal artery perforator flap with or without split-thickness skin grafting was performed for 10 men and 5 women patients with defects in the lateral malleolus. The mean age was 53.7 years with the age range between 22 and 89 years, and the mean size of the flaps was 40 cm^2. The soft tissue defects were caused by a diabetic foot (6 patients), infected bursitis (1 patient), chronic osteomyelitis (2 patients), and trauma (6 patients). Three of six diabetes mellitus patients also had peripheral arterial occlusive disease. The flaps were elevated in the form of a perforator flap, and split-thickness skin grafting was performed over the flaps and adjoining raw areas. The pedicled supramalleolar perforator flap is classified into two categories: (A) propeller and (B) rotation flaps. The mean follow-up duration was 30 months postsurgical.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propeller Flap | – | –The propeller flap is based on a perforator that serves as a pivot joint, allowing the flap to rotate up to 180°. It provides the advantages of greater freedom of movement and versatility in flap design. |
| Rotation Flap | – | –The rotation flap is primarily supplied by the perforator artery accompanied by the random supply from the skin base. It is also associated with a lower venous congestion risk. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 10 men and 5 women aged above 20 years old. The defects are caused by diabetes mellitus (6 subjects; 3 of them also have a peripheral arterial occlusive disease), infected bursitis (1 subject), chronic osteomyelitis (2 subjects), and trauma (6 subjects). The subjects have various comorbidity, i.e. no comorbidity (N), diabetes mellitus (DM), hypertensive cardiovascular disease (HCVD), hypertension (HTN), and peripheral arterial occlusive disease (PAOD). The defect size varies from 4 cm^2 to 25 cm^2, while the flap size varies from 9 cm^2 to 80 cm^2. The defects are located at the right or left (R or L) of the lateral malleolus of the ankle and/not at the pretibial area, or at the dorsal foot below the lateral malleolus.
Key inclusion criteria (2 listed)
- The subject is aged 20 years old or above (including 20 years old), regardless of gender.
- Patients with lateral ankle tissue defects
Key exclusion criteria (5 listed)
- The subject is aged under 20 years old.
- Patients with tissue metabolic disorders, immune dysfunction, and drug abuse.
- Patients with severe primary diseases or mental illness such as those involving the hematopoietic system, endocrine system, etc.
- Pregnant and lactating women.
- Patient who is unwilling or unable to cooperate with the trial process or follow medical advice.
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
Perforator flap type
Time frame: 3-60 months
The type of the flap is categorized into propeller and rotation flap. It is determined according to the distance between the perforator and the tip of the lateral malleolus. A distance of less than 2 cm used rotation-type perforator flap, while for a distance of greater than 2 cm would use propeller-type.
Flap size
Time frame: 3-60 months
The flap size is measured in the unit of cm^2. The flap size ranged from 4 cm × 3 cm to 16 cm × 6 cm.
Distance between the perforator and the tip of the lateral malleolus
Time frame: 3-60 months
The distances of all perforators from the wound, which is the tip of the lateral malleolus in this study, were measured in the unit of cm. The distance ranged from 2 cm to 5 cm.
Complication status
Time frame: 3-60 months
The complication status expresses the complication that occurred during the wound reconstruction. The status is stated as no complication (N) and the complication happened to the patients, such as "partial flap necrosis".
Follow-up month
Time frame: 3-60 months
The follow-up month indicates the duration and the follow-up of the wound reconstruction.
Donor site type
Time frame: 3-60 months
The donor site type indicates the type of skin grafting needed to be applied for covering the donor site of the patients. The donor site type in this study is divided into split-thickness skin grafting (STSG) and primary closure. The STSG was applied to 12 patients, whereas the primary closure was conducted on 3 patients.
Result status
Time frame: 3-60 months
The success of the reconstruction processes is stated in the result status. All flaps and skin graftings survived which implies all wound reconstructions were successful.
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 29 Dec 2020.
- Background: PubMed 2367579Hallock GG. Distal lower leg local random fasciocutaneous flaps. Plast Reconstr Surg. 1990 Aug;86(2):304-11. doi: 10.1097/00006534-199008000-00018.
- Background: PubMed 14646653Koshima I, Itoh S, Nanba Y, Tsutsui T, Takahashi Y. Medial and lateral malleolar perforator flaps for repair of defects around the ankle. Ann Plast Surg. 2003 Dec;51(6):579-83. doi: 10.1097/01.sap.0000095654.07024.65.
- Background: PubMed 8310021Wei FC, Seah CS, Tsai YC, Liu SJ, Tsai MS. Fibula osteoseptocutaneous flap for reconstruction of composite mandibular defects. Plast Reconstr Surg. 1994 Feb;93(2):294-304; discussion 305-6.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Tissue Injury Wound, run by National Defense Medical Center, Taiwan.
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 2 inclusion and 5 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 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Perforator flap type (time frame: 3-60 months). The study lists 7 primary outcomes in all. 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 NCT04687345, which also lists 3 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 29 Dec 2020.