NCT04643392

Brief Summary

Lipedema which causes excessive accumulation of fat in the subcutaneous tissue, is a rare, progressive disease. This disease generally affects women, following puberty or early adulthood and usually results in the slow increase of the circumference of the legs and/or arms, bilaterally. In a typical presentation of lipedema, the enlargement of the lower extremities is disproportionately greater than that of the trunk and upper extremities When first described in 1940, lipedema was thought to exclusively affect the lower extremities. However, as the disease has been recognized over the years, lipedema has been reported to affect the upper extremities. Upper extremity lipedema, with no involvement of the lower extremities is an extremely rare incident.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

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

September 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

November 18, 2020

Last Update Submit

November 18, 2020

Conditions

Keywords

Upper extremity lipedemaLymphatic drainage

Outcome Measures

Primary Outcomes (2)

  • Limb Circumference

    For every patient, the circumference measurements of the upper limbs were measured with the Perometer.

    Change from baseline circumference at 4 weeks

  • Limb Volume

    For every patient, the volume measurements of the upper limbs were measured with the Perometer.

    Change from baseline volume at 4 weeks

Study Arms (1)

Patients with Lipedema

Participants who were diagnosed with upper extremity lipedema by a lymphologist.

Procedure: Complex decongestive physiotherapy

Interventions

Each patient received a treatment protocol of Complex decongestive physiotherapy for 5 days a week until they were discharged from the clinic. All patients fully completed all components of the treatment routine daily. The treatment was performed by a physiotherapist who was certified with Manual Lymph Drainage Combined Decongestive Physiotherapy. After the daily treatment protocol was completed, patients wore standard or individually sized compression grade II or III medical compression stockings for the rest of the day.

Patients with Lipedema

Eligibility Criteria

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

Patients between the age of 18-65 who have lipedema affecting the upper extremities and no accompanying diagnosis of lymphedema, deep vein thrombosis or any disease which causes edema in the upper extremities.

You may qualify if:

  • being between the ages of 18-65,
  • having a diagnosis of upper extremity lipedema
  • being willing to participate in the study

You may not qualify if:

  • accompanying diagnosis of lymphedema,
  • deep vein thrombosis
  • disease which causes edema in the upper extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas University

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (1)

  • Volkan-Yazici M, Esmer M. Reducing Circumference and Volume in Upper Extremity Lipedema: The Role of Complex Decongestive Physiotherapy. Lymphat Res Biol. 2022 Feb;20(1):71-75. doi: 10.1089/lrb.2020.0128. Epub 2021 Apr 5.

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Melek Volkan-Yazici, PT. PhD

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Murat Esmer, PT. MSc

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 25, 2020

Study Start

September 2, 2019

Primary Completion

February 3, 2020

Study Completion

May 4, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations