Edema
Conditions
Interventions
This is a randomized, controlled, open-label, intra-individual clinical trial involving 30 participants. Due to the intra-individual design, each participant will simultaneously receive both intervent
Sponsors
Abralipedema Pro Organização de Ensino Ltda
Venosan Brasil Ltda
Eligibility
Sex/Gender
Female
Age
25 Years to 35 Years
Inclusion criteria
Inclusion criteria: Women aged 25 to 35 years; with a clinical diagnosis of type III lipedema, stages II or III; bilateral involvement of the lower limbs; Ankle-Brachial Index (ABI) between 0.91 and 1.30; clinical indication for compression therapy; who do not engage in regular physical activity, defined as structured, planned, and systematic exercise performed less than twice per week during the previous three months; who present a score of 4 or higher for at least two of the following symptoms on the Lipedema Symptom Assessment Questionnaire (QuASiL): pain, sensation of heaviness, tenderness to touch, or functional impairment related to the lower limbs; who agree to wear the compression garments for 60 consecutive days for a minimum of 8 hours per day; who attend all study assessments; and who provide written informed consent.
Exclusion criteria
Exclusion criteria: Participants who are pregnant or breastfeeding; have a diagnosis of primary or secondary lymphedema; have a history of deep vein thrombosis or thrombophlebitis within the previous 12 months; have peripheral arterial disease or a clinical contraindication to compression therapy; have decompensated heart failure; present active skin lesions, infections, dermatitis, or inflammatory conditions affecting the lower limbs; have undergone orthopedic surgery or experienced trauma involving the lower limbs within the previous 12 months; have physical limitations preventing the performance of the proposed functional tests; have regularly used compression garments during the previous three months; are concurrently participating in another therapeutic protocol for lipedema during the study period; have a diagnosis of neurological, rheumatologic, or vascular diseases that may interfere with lower-limb function; or use medications or therapies that may directly affect outcomes related to pain, edema, or vascular response, as determined by the research team, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of flat-knit compression garments (20–30 mmHg and 30–40 mmHg) on lower-limb volume, lipedema-related symptoms, and functional performance after 60 days of use. Outcomes will be assessed using limb circumference measurements and truncated cone volumetric calculations, the Lipedema Symptom Assessment Questionnaire (QuASiL), the Visual Analog Scale (VAS), the Tip-Toe Test, the Weight-Bearing Lunge Test (WBLT), and the Single Leg Stance Test (SLST). Differences between baseline (T0) and day 60 (T60), as well as between compression levels, will be analyzed.ion stocking use. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of different compression levels on body composition, segmental fluid distribution, skin temperature, interface pressure, quality of life, comfort, and treatment adherence. Outcomes will be assessed using bioelectrical impedance analysis, infrared thermography, PicoPress®, the SF-36 questionnaire, and a compression garment tolerability questionnaire. Changes between baseline (T0) and day 60 (T60), as well as differences between compression levels, will be analyzed. | — |
Countries
BR
Contacts
Public ContactPaula de Souza
Abralipedema Pro
Outcome results
None listed