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

Official title

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

Overview

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.

Detailed description

Lipedema, described by Allen and Hines in 1940, is a syndrome characterized by painful edema in the lower limbs associated with a frequent occurrence of bruises. It mainly affects women and is usually symmetrical.

The management of patients depends on the stage and the presence of edema. In the maintenance phase, the goal is to prevent edema recurrence to avoid an increase in fat deposition in the lower limbs through the use of compression garments.

Currently, there are no guidelines for prescribing compression garments for patients with lipedema regarding the type of garment, fabric, or compression level. Therefore, the prescription by lymphologists is empirical and based on experience.

This study, the first of its kind, aims to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing the volume of the lower limbs and improving or stabilizing the signs and symptoms of patients with lipedema. The study also aims to determine if there are differences between the two types of garments currently used in routine clinical practice.

In order to provide scientific knowledge to guide these decisions, a prospective randomized crossover experimental study is proposed in patients with lipedema type III, stages 1 and 2, undergoing maintenance treatment with circular compression stockings for a minimum of 6 months. Patients meeting inclusion criteria will be randomized to continue receiving a compression garment with the same circular fabric they were wearing or alternatively switch to a compression garment with flat fabric, both for 6 months.

After 6 months, the study goals will be evaluated, and a simple crossover will be performed, switching to the other type of garment for another 6 months. In other words, patients wearing circular fabric garments will change to flat fabric compression garments and vice versa. At the end of the subsequent 6 months, the study goals will be reassessed once more.

To assess the study goals, we will record several variables related to:

* The effectiveness of circular and flat fabric garments * Patient satisfaction with the garments * Compliance with garment use * Patient complaints about the garments

Therefore, patients will be recieve a follow-up visit at 6 months from the baseline assessment and at 6 months after crossover treatment. Garment usage will be assessed through automated calls every 2 weeks during the whole follow-up period.

Interventions

• Device Flat-knitted compression garment
  Flat knitted compression garments

Primary outcome measures

• Percentage of Volume Change (PVC) [Time frame: at the 6th and 12th month of treatment]

Secondary outcome measures (7)

• Pain intensity [Time frame: at the 6th and 12th month of treatment]
• Heaviness [Time frame: at the 6th and 12th month of treatment]
• Numbness [Time frame: at the 6th and 12th month of treatment]
• Characteristics of pain [Time frame: at the 6th and 12th month of treatment]
• Compliance [Time frame: at the 6th and 12th months of treatment]
• Reported Quality of Life [Time frame: at the 6th and 12th months of treatment]
• Pressure pain threshold [Time frame: at baseline, 6th and 12 th months.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitari i Politecnic La Fe — Valencia

Publications

• Michelini S, Chiurazzi P, Marino V, Dell'Orco D, Manara E, Baglivo M, Fiorentino A, Maltese PE, Pinelli M, Herbst KL, Dautaj A, Bertelli M. Aldo-Keto Reductase 1C1 (AKR1C1) as the First Mutated Gene in a Family with Nonsyndromic Primary Lipedema. Int J Mol Sci. 2020 Aug 29;21(17):6264. doi: 10.3390/ijms21176264. PMID 32872468
• Ghods M, Georgiou I, Schmidt J, Kruppa P. Disease progression and comorbidities in lipedema patients: A 10-year retrospective analysis. Dermatol Ther. 2020 Nov;33(6):e14534. doi: 10.1111/dth.14534. Epub 2020 Nov 22. PMID 33184945
• Herbst KL, Mirkovskaya L, Bharhagava A, Chava Y, Te CHT. Lipedema fat and signs and symptoms of illness, increase with advancing stage. Archives of Medicine. 2015; 7(4): 1-8.
• Kumar B, Lenert P. Joint Hypermobility Syndrome: Recognizing a Commonly Overlooked Cause of Chronic Pain. Am J Med. 2017 Jun;130(6):640-647. doi: 10.1016/j.amjmed.2017.02.013. Epub 2017 Mar 10. PMID 28286166
• Forner-Cordero I, Muñoz-Langa J, Vázquez-Díez J. Lipedema patients have a high prevalence of joint hypermobility. ISL XXVII WORLD CONGRESS 2019, International Society of Lymphology, Buenos Aires (Argentina), September 23-28, 2019.
• WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available. PMID 14830102
• Herbst KL. Rare adipose disorders (RADs) masquerading as obesity. Acta Pharmacol Sin. 2012 Feb;33(2):155-72. doi: 10.1038/aps.2011.153. PMID 22301856
• Schmeller W, Meier-Vollrath I. Das Lipodem: neue Möglichkeiten der Therapie. Schweiz Med Forum. 2007;7:150-155.

Identifiers

NCT: NCT06964828 · LipeGar

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗