An interventional study of Flat-knitted compression garment in Lipedema, sponsored by Isabel Forner-Cordero, MD, PhD. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Isabel Forner-Cordero, MD, PhD · Not applicable, Interventional, and Treatment
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.
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:
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 34 is close to the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →This is the only study on the registry with Isabel Forner-Cordero, MD, PhD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The patient will change to a flat-knitted pantyhose in class 2 for 6 months
Device: Flat-knitted compression garment
Flat knitted compression garments
Also known as: Circular-knitted compression garment
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.
Time frame: at the 6th and 12th month of treatment
Pain intensity
Pain in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Time frame: at the 6th and 12th month of treatment
Heaviness
Perceived heaviness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Time frame: at the 6th and 12th month of treatment
Numbness
Numbness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Time frame: at the 6th and 12th month of treatment
Characteristics of pain
Location and type of sensation.
Time frame: at the 6th and 12th month of treatment
Compliance
Number of hours per day and days per week, wearing the compression garments
Time frame: at the 6th and 12th months of treatment
Reported Quality of Life
LYMQOL (Lymphedema Quality of Life) questionnaire. Individual item scores range from 0 (least impact in quality of life or QOL) to 4 (maximum impact in QOL). Total scores may be calculated as a mean of all individual answers or as a percentage of the maximum possible score. The last question regarding overall quality of life is measured using the visual analogue scale (VAS) ranging from 0 (worst possible QOL) to 10 (best possible QOL).
Time frame: at the 6th and 12th months of treatment
Pressure pain threshold
Pressure pain threshold (PPT) will be assessed at the thigh using an algometer. Units: Newtons (N).
Time frame: at baseline, 6th and 12 th months.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.