NCT07060703

Brief Summary

Clinical and paraclinical characterization of osseous anomalies of the long bones of patients with Klippel Trénaunay syndrome

Trial Health

75
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Sep 2024Oct 2026

First Submitted

Initial submission to the registry

September 12, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 12, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

July 11, 2025

Status Verified

March 1, 2025

Enrollment Period

3 days

First QC Date

September 12, 2024

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes

Secondary Outcomes (4)

  • description vascular of the KTS.

    30 MINUTES

  • measurement of bone density (BMD) in the spine and femoral necks, with calculation of the FRAX index.

    20 MINUTES

  • exploration of long bones using non-invasive Guided Wave Velocity (GWV) technology.

    20 MINUTES

  • description vascular of the KTS.

    20 minutes

Study Arms (1)

Radiological Bone Phenotype Description of Patients With KTS

OTHER
Diagnostic Test: Osteodensitometry

Interventions

OsteodensitometryDIAGNOSTIC_TEST

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. \[Time Frame: 20 MIN\]

Also known as: non-invasive technology Speed of Guided Waves
Radiological Bone Phenotype Description of Patients With KTS

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breast-feeding woman Protected person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

La Tronche, 38700, France

Location

Study Officials

  • SOPHIE M BLAISE, INVESTOGATOR

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2024

First Posted

July 11, 2025

Study Start

September 12, 2024

Primary Completion

September 15, 2024

Study Completion (Estimated)

October 1, 2026

Last Updated

July 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations