Actively Recruiting
Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
Led by Isabel Forner-Cordero, MD, PhD · Updated on 2025-05-14
34
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
I
Isabel Forner-Cordero, MD, PhD
Lead Sponsor
H
Hospital Provincial de Castellon
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of lipedema with increased lower-limb volume, disproportion between upper and lower body, and pain
- Lipedema type III, stage 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 hygiene and water activities)
- Provided written informed consent to participate
You will not qualify if you...
- Lipedema with fatty lobulations
- Body Mass Index (BMI) 30 kg/m2 or higher
- Waist-to-Height Ratio greater than 0.53
- Pregnancy
- Renal, hepatic, or cardiac insufficiency
- Thrombosis in the lower extremities
- Infection in the lower extremities
- Active cancer
- Current treatment with corticosteroids or medications promoting fluid retention
- Unable to read the Patient Information Form or provide consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
Research Team
I
ISABEL FORNER-CORDERO, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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