BridgeMD
Tests treatment safety and results for Lipedema
Official title Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
ClinicalTrials.gov ID: NCT06964828
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join 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).
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.