Lipedema Clinical Trials

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Proof of Concept, Randomized, Controlled, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments (Flat vs Circular Knitted) in the Maintenance Treatment of Patients With Lipedema

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this prospective randomized crossover experimental study is to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing lower-limb volume in lipedema. It will assess the effectiveness of the garments and determine any differences between both types of hosiery currently used in routine clinical practice. Participants will be prescribed either circular or flat-knitted pantyhose and wear them daily for 6 months. After 6 months, they will change the type of garment.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Clinical diagnosis of lipedema: increased lowe-limb volume, disproportion between upper and lower body, and pain.

• Lipedema type III stages 1 or 2.

• Negative pitting sign.

• In maintenance treatment phase with a class II circular-knitted compression garment for at least 6 months.

• Adequate compliance with compression garments (worn during the day, except during personal hygiene and water-related activities).

• Written informed consent to participate.

Locations
Other Locations
Spain
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Contact Information
Primary
ISABEL FORNER-CORDERO, MD, PhD
ifornercordero@gmail.com
+34649179852
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2026-07
Participants
Target number of participants: 34
Treatments
Active_comparator: Circular-knitted compression garments
The patient will continue using a compression garment with the same fabric she was wearing before inclusion (circular knitted pantyhose in class 2)
Experimental: Flat-knitted compression garments
The patient will change to a flat-knitted pantyhose in class 2 for 6 months
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Arnau de Vilanova, Hospital Provincial de Castellon
Leads: Isabel Forner-Cordero, MD, PhD

This content was sourced from clinicaltrials.gov