Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema

NCT06964828 | Recruiting

• 1 other identifier: LipeGar
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipedema

Keywords

Lipedema; Compression garments; Maintenance treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of Volume Change (PVC)

  The Percentage of Volume Change (PVC) at the 6th and 12th month of treatment is calculated using the following mathematical formula: PVC = \[ (Baseline volume- final volume)/ baseline volume\] x 100 Where: * Baseline is the reference volume at the beginning of the treatment. * Final Volume is the volume at the end of the treatment period (either at the 6th or 12th month). This calculation provides the percentage change in volume of the lower limbs over the course of the treatment period compared to the initial volume. We consider maintenance treatment is successful when the Percentage of Volume Change (PVC) is \<10% after 6 or 12 months of treatment, relative to the study's baseline. We define disease progression when the PVC is \>10% at 6 or 12 months, relative to the study's baseline.

  at the 6th and 12th month of treatment

Secondary Outcomes (7)

• Pain intensity

  at the 6th and 12th month of treatment

• Heaviness

  at the 6th and 12th month of treatment

• Numbness

  at the 6th and 12th month of treatment

• Characteristics of pain

  at the 6th and 12th month of treatment

• Compliance

  at the 6th and 12th months of treatment

Study Arms (2)

Circular-knitted compression garments

ACTIVE COMPARATOR

The patient will continue using a compression garment with the same fabric she was wearing before inclusion (circular knitted pantyhose in class 2)

Device: Flat-knitted compression garment

Flat-knitted compression garments

EXPERIMENTAL

The patient will change to a flat-knitted pantyhose in class 2 for 6 months

Device: Flat-knitted compression garment

Interventions

Flat-knitted compression garment DEVICE

Flat knitted compression garments

Also known as: Circular-knitted compression garment

Circular-knitted compression garments; Flat-knitted compression garments

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Lipedema with fatty lobulations.
• Body Mass Index (BMI) ≥ 30 kg/m2.
• Waist-to-Height Ratio \> 0.53.
• Pregnancy.
• Renal, hepatic, or cardiac insufficiency.
• Thrombosis in the lower extremities.
• Infection in the lower extremities.
• Active oncological process.
• Current treatment with corticosteroids and other medications that promote fluid retention.
• Inability to read the Patient Information Form (HIP) and/or provide consent to participate in the study.

Sponsors & Collaborators

• Isabel Forner-Cordero, MD, PhD: lead
• Hospital Provincial de Castellon: collaborator
• Hospital Arnau de Vilanova: collaborator

Study Sites (1)

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Related Publications (26)

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  PMID: 32872468 BACKGROUND

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  PMID: 33184945 BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 28961048 BACKGROUND

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  BACKGROUND

• Nemes A, Kormanyos A, Domsik P, Kalapos A, Kemeny L, Szolnoky G. The impact of lower body compression garment on left ventricular rotational mechanics in patients with lipedema-Insights from the three-dimensional speckle tracking echocardiographic MAGYAR-Path Study. Clin Obes. 2020 Oct;10(5):e12380. doi: 10.1111/cob.12380. Epub 2020 Jun 23.

  PMID: 32573965 BACKGROUND

• Forner-Cordero I, Tortosa-Soriano G, Alabajos-Cea A, Ponce-Garrido AB, Muñoz-Langa J. Effect of compression alone or combined with exercise in patients with lipedema. A pilot study. In: Abstracts of the 42nd European Society of Lymphology Congress. Eur J Lymphol Relat Probl. 2016; 28(74): 70.

  BACKGROUND

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  PMID: 28677175 BACKGROUND

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  PMID: 22716023 BACKGROUND

• Forner-Cordero I, Szolnoky G, Forner-Cordero A, Kemeny L. Lipedema: an overview of its clinical manifestations, diagnosis and treatment of the disproportional fatty deposition syndrome - systematic review. Clin Obes. 2012 Jun;2(3-4):86-95. doi: 10.1111/j.1758-8111.2012.00045.x. Epub 2012 Aug 3.

  PMID: 25586162 BACKGROUND

• Forner-Cordero I, Perez-Pomares MV, Forner A, Ponce-Garrido AB, Munoz-Langa J. Prevalence of clinical manifestations and orthopedic alterations in patients with lipedema: A prospective cohort study. Lymphology. 2021;54(4):170-181.

  PMID: 35073621 BACKGROUND

• Forner-Cordero I, Forner-Cordero A, Szolnoky G. Update in the management of lipedema. Int Angiol. 2021 Aug;40(4):345-357. doi: 10.23736/S0392-9590.21.04604-6. Epub 2021 Apr 19.

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  BACKGROUND

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  PMID: 15560108 BACKGROUND

• Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• ISABEL FORNER-CORDERO, MD, PhD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ISABEL FORNER-CORDERO, MD, PhD

CONTACT

+34649179852; ifornercordero@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Specialist in Physical Medicine and Rehabilitation, Associate professor of University of Valencia

Model Details: Patients meeting the inclusion criteria will be randomized to either continue wearing a compression garment with circular fabric or switch to a compression garment with flat fabric, both for 6 months. At 6 months, the study goals will be evaluated, and a simple crossover will occur. Patients will switch to the other type of garment for another 6 months.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: May 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)