Lipedema: an overview of its clinical manifestations, diagnosis and treatment of the disproportional fatty deposition syndrome - systematic review.
I Forner-Cordero, G Szolnoky, A Forner-Cordero...
https://pubmed.ncbi.nlm.nih.gov/25586162/Actively Recruiting
Led by Isabel Forner-Cordero, MD, PhD · Updated on 2025-05-14
34
Participants Needed
1
Research Sites
N/A
Total Duration
Lipedema is a condition mainly affecting women, characterized by painful swelling and bruising in the lower limbs, often occurring symmetrically. Researchers are evaluating two types of compression garmentscircular-knitted and flat-knitted pantyhoseto see how well they stabilize lower-limb volume and relieve symptoms in patients with lipedema type III, stages 1 and 2, during maintenance treatment. This study aims to provide scientific guidance on garment selection, which is currently based on experience rather than established guidelines. Participants will be randomly assigned to continue wearing their current circular-knitted compression garment or switch to a flat-knitted pantyhose, both class II compression, for six months. After this period, they will switch to the other garment type for another six months, creating a crossover design. The study will assess garment effectiveness, tolerance, patient satisfaction, and compliance throughout these treatment phases. During the study, participants will have follow-up visits at six months and at the end of the twelve-month period after crossover. Researchers will monitor lower-limb volume changes, pain intensity, heaviness, numbness, pain characteristics, pressure pain threshold, quality of life, and compliance. Garment use adherence will be tracked through automated calls every two weeks during the entire follow-up. The total study duration for each participant is twelve months.
CONDITIONS
Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
I
ISABEL FORNER-CORDERO, MD, PhD
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Isabel Forner-Cordero, MD, PhD
Lead Sponsor
Hospital Provincial de Castellon
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants wear either circular-knitted or flat-knitted compression garments for 6 months to assess their effectiveness in managing lipedema symptoms.
Baseline visit and 1 follow-up visit at 6 months
Duration - 6 months
Participants switch to the other type of compression garment for another 6 months to compare effectiveness and tolerance.
1 follow-up visit at 12 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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I Forner-Cordero, G Szolnoky, A Forner-Cordero...
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https://pubmed.ncbi.nlm.nih.gov/33184945/Isabel Forner-Cordero, MD, PhD
Lead Sponsor
Hospital Provincial de Castellon
Collaborating Sponsor