NCT06399458

Brief Summary

Lymphoedema is the swelling of one or several parts of the body owing to lymph accumulation in the extracellular space. It is often chronic, worsens if untreated, predisposes to infections and causes an important reduction in quality of life.Primary lymphoedema (PLE) is thought to result from abnormal development and/or functioning of the lymphatic system, can present in isolation or as part of a syndrome, and can be present at birth or develop later in life. Joint hypermobility ( JH) is a clinical condition characterized an excess range of motion in a joint beyond the physiological range of motion . It is termed generalized joint hypermobilty (GJH) , when the condition is asymptomatic; when it is associated with symptoms such as arthralgia, soft tissue damage, and joint instability, it is referred to as benign joint hypermobility syndrome (BJHS) .An increase in the proportion of collagen or collagen subtypes, such as type III/type I has been detected in JH . This abnormal collagen structure causes joint laxity, and fragility of the connective tissue increases. The lymphatic system begins to develop at the end of the fifth gestational week. Lymphatic vessels and lymph nodes develop from the mesoderm. Mesoderm differentiates to form many tissues and structures, including connective tissue, muscle, bone, urogenital and circulatory systems. The relationships between systems developing from the same mesoderm-derived structures (such as carpal tunnel hypermobility, lumbar disc herniation hypermobility, shoulder impigment and adhesive capsulitis hypermobility) and joint hypermobility were examined. There are studies showing that hypermobility may pose a risk for venous insufficiency. In addition, one of the criteria for benign joint hypermobility syndrome is the presence of varicose veins. It has been revealed that the lymphatic system develops embryonicly from the cardinal vein, intersomatic vein and lymphangioblasts. Therefore, the lymphatic system can be considered as a branch of the developmental venous system with endothelial vascular walls. We aimed to investigate the relationship between primary lymphedema and joint hypermobility, as it has not been investigated before in the literature and based on this developmental similarity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

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

March 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 1, 2024

Last Update Submit

May 1, 2024

Conditions

Keywords

primary lymphedema, hyper mobility, Beighton score

Outcome Measures

Primary Outcomes (2)

  • Beighton Hypermobility Score

    The following examinations are performed for the Beighton hypermobility score:1. Ability to touch palms flat to floor with knees straight (one point) 2. Elbow extension \>10° (one point for each side) 3. Knee extension \>10° (one point for each side) 4. Ability to touch thumb to forearm (one point for each side) 5. Fifth finger metocarpalphalageal joint extension \>90° (one point for each side) Scores of 4 or above indicate Generalised Joint Hypermobility.

    1 day

  • Revised Brighton Criteria

    The Brighton Criteria is used in adults to diagnose Joint Hypermobility Syndrome. To make the diagnosis you need one of: two major criteria; one major and two minor criteria; four minor criteria; two minor criteria and one affected first degree relative. The presence of an underlying syndrome excludes the diagnosis. Major Criteria: Beighton Score \>3, Arthralgia \> 3 months in four or more joints. Minor Criteria: Beighton Score 1-3, Arthralgia \> 3 months in one joint, backpain, or spondylosis / spondylolysis / ,spondylolisthesis. Dislocation or subluxation in more than one joint, or in one joint repeatedly. Three or more soft tissue lesions (e.g epicondylitis, tenosynovitis, bursitis). Marfanoid habitus. Skin striae. Ocular signs (e.g drooping eyelids, myopia, antimongoloid slant). Varicose veins, hernia, uterine or rectal prolapse. Mitral valve prolapse.

    1 day

Study Arms (2)

1. group

Patients with lymphedema in the lower extremity

Diagnostic Test: For hypermobility; Beighton score and Brighton revised 1998 Criteria

2. group

Patients with lymphedema or no edema in the lower extremities

Diagnostic Test: For hypermobility; Beighton score and Brighton revised 1998 Criteria

Interventions

Beighton score and Brighton revised 1998 Criteria

1. group2. group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Our study included male and female patients between the ages of 18-65 with primary lymphedema in the lower extremities and healthy volunteers in the same age range who did not have complaints such as edema or lymphedema in the lower extremities.

You may qualify if:

  • Patients diagnosed with primary lymphedema between the ages of 18-65. Individuals between the ages of 18-65 without a diagnosis of lymphedema. Lymphedema stage 1,2,3 patients. Sufficient cognitive functions.

You may not qualify if:

  • Being diagnosed with secondary lymphedema. Patients with lower extremity edema due to other reasons (such as cardiac, nephrogenic, myxedema), in this context, patients with cardiac failure, renal failure, thyroid hormone disorders Patients using edema-inducing drugs (corticosteroids, calcium channel blockers, gabapentin, pregabalin Patients diagnosed with rheumatological disease Patients with signs of infection in their legs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Feyza Akan Begoğlu

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 3, 2024

Study Start

March 15, 2024

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations