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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04643392
Other study ID # YIU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2, 2019
Est. completion date May 4, 2020

Study information

Verified date November 2020
Source Yuksek Ihtisas University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Due to the hypertrophy in adipose tissue, the link between lymphatic dysfunction and the progression to lipo-lymphedema, lipedema is conservatively treated with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy. Furthermore, the consensus of the International Society of Lymphology has stated that intermittent pneumatic compression is an optional treatment which may be applied as an adjuvant therapy to complex decongestive physiotherapy. All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy and intermittent pneumatic compression. The Perometer was used in the measurement of upper extremity volume and circumference before and after treatment.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 4, 2020
Est. primary completion date February 3, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - being between the ages of 18-65, - having a diagnosis of upper extremity lipedema - being willing to participate in the study Exclusion Criteria: - accompanying diagnosis of lymphedema, - deep vein thrombosis - disease which causes edema in the upper extremities

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Complex decongestive physiotherapy
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.

Locations

Country Name City State
Turkey Yuksek Ihtisas University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Yuksek Ihtisas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Limb Circumference For every patient, the circumference measurements of the upper limbs were measured with the Perometer. Change from baseline circumference at 4 weeks
Primary Limb Volume For every patient, the volume measurements of the upper limbs were measured with the Perometer. Change from baseline volume at 4 weeks
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