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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Percentage of Volume Change (PVC)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of lipedema: increased lowe-limb volume, disproportion between upper and lower body, and pain.
- •Lipedema type III stages 1 or
- •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/m
- •Waist-to-Height Ratio > 0.
- •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.
Arms & Interventions
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)
Intervention: Flat-knitted compression garment (Device)
Flat-knitted compression garments
The patient will change to a flat-knitted pantyhose in class 2 for 6 months
Intervention: Flat-knitted compression garment (Device)
Outcomes
Primary Outcomes
Percentage of Volume Change (PVC)
Time Frame: at the 6th and 12th month of treatment
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.
Secondary Outcomes
- 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)
- Pain intensity(at the 6th and 12th month of treatment)
- Compliance(at the 6th and 12th months of treatment)
- Reported Quality of Life(at the 6th and 12th months of treatment)
- Pressure pain threshold(at baseline, 6th and 12 th months.)
Investigators
Isabel Forner-Cordero, MD, PhD
MD, PhD, Specialist in Physical Medicine and Rehabilitation, Associate professor of University of Valencia
Instituto de Investigacion Sanitaria La Fe