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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender Female
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06964828
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Isabel Forner-Cordero, MD, PhD
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ISABEL FORNER-CORDERO, MD, PhD
Principal Investigator Affiliation Hospital Universitario La Fe
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lipedema
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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)

Experimental: Flat-knitted compression garments

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

Interventions

Device: - Flat-knitted compression garment

Flat knitted compression garments

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Universitari i Politecnic La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe

Valencia, , 46026

Site Contact

Isabel Forner-Cordero, PhD

[email protected]

+34 96 124 66 05

Nearest Location

Site Contact

Isabel Forner-Cordero, PhD

[email protected]

+34 96 124 66 05

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The content provided in the Lipedema Foundation Legwork program is for informational purposes and does not, under any circumstance, constitute medical advice. Consult with your healthcare provider regarding any changes to your lipedema treatment including participation in any study. Information provided here is maintained by the TrialScope vendor and supplied by the individual study teams. Use of the TrialScope service requires acceptance of the TrialScope privacy policy and terms of service. Some features of the service may require registration of the user's contact information with TrialScope through the TrialScope website. Do not register if you do not consent to providing such information. The Lipedema Foundation does not guarantee that the contents are accurate or complete, or that any given study will be available for participation or applicable to your condition. The listing of a study on the site does not constitute an endorsement or recommendation of that study by the Lipedema Foundation. As such, you hereby waive claims and liability against the Lipedema Foundation for any harm, including bodily injury and death, that may result in connection with the use of this service. The Lipedema Foundation reserves the right, at its discretion, to omit studies or add studies to the service without notice. The Lipedema Foundation does not represent that the list of studies presented through the service is complete.

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