Radiological Bone Phenotype Description of Patients With KTS ( Klippel-Trénaunay Syndrome )KTSOSNCT07060703
Clinical and Paraclinical Characterization of Osseous Anomalies of the Long Bones of Patients With Klippel Trénaunay Syndrome
A study testing Osteodensitometry in people with Radiological Bone Phenotype Description of Patients With KTS ( Klippel-Trénaunay Syndrome ), run by University Hospital, Grenoble at 1 site in France.
Trial summary
Clinical and paraclinical characterization of osseous anomalies of the long bones of patients with Klippel Trénaunay syndrome Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Radiological Bone Phenotype Description of Patients With KTS ( Klippel-Trénaunay Syndrome )
- What is being tested?
- Osteodensitometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Vascular malformation such as Klippel-Trénaunay syndrome or Capillary malformations (CM) + venous malformations (VM) +/- Lymphatic malformations (LM) + limb overgrowth according to ISSVA (International Society for the Study of Vascular Anomalies) classification.
- Signature of study consent by subject of legal age or by 2 legal guardians for minors Patient affiliated to a social security scheme or beneficiary of such a scheme
- Age greater than or equal to 7 years
Who cannot join
- Pregnant or breast-feeding woman Protected person
- -
Trial locations and contacts
1 site in 1 country.
About this study
Clinical and paraclinical characterization of osseous anomalies of the long bones of patients with Klippel Trénaunay syndrome
Read the detailed description
The objective is to better characterize bone damage in KTS as well as their risks in the shorter or medium term (potentially higher risks of long bone fractures, hemorrhagic risks in the event of a long bone fracture, osteoarthritis risks or risk osteoporosis) as well as the need for rheumatological care in the care pathway.
- Conditions
- Radiological Bone Phenotype Description of Patients With KTS ( Klippel-Trénaunay Syndrome )
- Being tested
- Osteodensitometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteodensitometryDiagnostic test
Also called non-invasive technology Speed of Guided Waves
exploration of long bones using non-invasive Guided Wave Velocity (GWV) technology.
comparison of ultrasound parameters (cortical thickness and porosity, among others) with BMD values (spine, right and left femoral necks) obtained by DXA.
[Time Frame: 20 MIN]
| Study group | Role | What they receive |
|---|---|---|
| Radiological Bone Phenotype Description of Patients With KTS | Other | Not described Receives: Diagnostic Test: Osteodensitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of limb-length asymmetry on lower-limb telemetry (absolute values, in mm) compared with the contralateral side
The assessment of bone damage includes an X-ray of a weight-bearing pelvis and limb telemetry to detect any limb length abnormalities.
Measured: 20 minutes
Secondary outcomes (4)
description vascular of the KTS.
classification of vascular dysplasia using the International Classification of Vascular Anomalies (ISSVA), Hamburg classification, presence or absence of lymphatic involvement, presence or absence of localized or diffuse intravascular coagulopathy, vascular infiltrative bone involvement on MRI.
Measured: 30 MINUTES
measurement of bone density (BMD) in the spine and femoral necks, with calculation of the FRAX index.
quantitative analysis with measurement of bone density (BMD) in the spine and 2 femoral necks by bone densitometry, images obtained by two-photon X-ray absorptiometry or DXA combined with clinical risk factors using the FRAX tool.
Measured: 20 MINUTES
exploration of long bones using non-invasive Guided Wave Velocity (GWV) technology.
comparison of ultrasound parameters (cortical thickness and porosity, among others) with BMD values (spine, right and left femoral necks) obtained by DXA.
Measured: 20 MINUTES
description vascular of the KTS.
Cortical thickness (Ct.Th) expressed en mm and porosity (Ct.Po) expressed in percentage %.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start12 Sep 2024
- Primary completion15 Sep 2024
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiological Bone Phenotype Description of Patients With KTS ( Klippel-Trénaunay Syndrome )Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SOPHIE M BLAISE, INVESTOGATOR, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060703
- Sponsor's protocol ID
- 2023-A02765-40
- Acronym
- KTSOS
- Status last verified
- Mar 2025
- First submitted
- 12 Sep 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Paraclinical Characterization of Osseous Anomalies of the Long Bones of Patients With Klippel Trénaunay Syndrome
- ClinicalTrials.gov ID
- NCT07060703
- Acronym / sponsor ID
- KTSOS / 2023-A02765-40
- Conditions
- Radiological Bone Phenotype Description of Patients With KTS ( Klippel-Trénaunay Syndrome )
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 Jul 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.
Clinical and paraclinical characterization of osseous anomalies of the long bones of patients with Klippel Trénaunay syndrome
Detailed description
The objective is to better characterize bone damage in KTS as well as their risks in the shorter or medium term (potentially higher risks of long bone fractures, hemorrhagic risks in the event of a long bone fracture, osteoarthritis risks or risk osteoporosis) as well as the need for rheumatological care in the care pathway.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiological Bone Phenotype Description of Patients With KTS | Other | Diagnostic Test: Osteodensitometry |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Vascular malformation such as Klippel-Trénaunay syndrome or Capillary malformations (CM) + venous malformations (VM) +/- Lymphatic malformations (LM) + limb overgrowth according to ISSVA (International Society for the Study of Vascular Anomalies) classification.
- Signature of study consent by subject of legal age or by 2 legal guardians for minors Patient affiliated to a social security scheme or beneficiary of such a scheme
- Age greater than or equal to 7 years
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding woman Protected person
- -
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 |
|---|---|---|
| OsteodensitometryAlso: non-invasive technology Speed of Guided Wavesexploration of long bones using non-invasive Guided Wave Velocity (GWV) technology. comparison of ultrasound parameters (cortical thickness and porosity, among others) with BMD values (spine, right and left femoral necks) obtained by DXA. [Time Frame: 20 MIN] | Diagnostic test | Radiological Bone Phenotype Description of Patients With KTS |
Primary outcome
Quantification of limb-length asymmetry on lower-limb telemetry (absolute values, in mm) compared with the contralateral side
Time frame: 20 minutes
The assessment of bone damage includes an X-ray of a weight-bearing pelvis and limb telemetry to detect any limb length abnormalities.
4 secondary outcomes
description vascular of the KTS.
Time frame: 30 MINUTES
measurement of bone density (BMD) in the spine and femoral necks, with calculation of the FRAX index.
Time frame: 20 MINUTES
exploration of long bones using non-invasive Guided Wave Velocity (GWV) technology.
Time frame: 20 MINUTES
description vascular of the KTS.
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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.
SOPHIE M BLAISE, INVESTOGATOR principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteodensitometry in people with Radiological Bone Phenotype Description of Patients With KTS ( Klippel-Trénaunay Syndrome ), run by University Hospital, Grenoble at 1 site in France.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quantification of limb-length asymmetry on lower-limb telemetry (absolute values, in mm) compared with the contralateral side (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.