Proof of Concept, Randomized, Controlled, and Crossover Study to Assess the Effectiveness of Flat vs Circular Knitted Compression Garments in Maintenance Treatment of Lipedema

What this Trial Is About

Lipedema is a condition mainly affecting women, characterized by painful swelling and bruising in the lower limbs, often occurring symmetrically. Researchers are evaluating two types of compression garments—circular-knitted and flat-knitted pantyhose—to see how well they stabilize lower-limb volume and relieve symptoms in patients with lipedema type III, stages 1 and 2, during maintenance treatment. This study aims to provide scientific guidance on garment selection, which is currently based on experience rather than established guidelines. Participants will be randomly assigned to continue wearing their current circular-knitted compression garment or switch to a flat-knitted pantyhose, both class II compression, for six months. After this period, they will switch to the other garment type for another six months, creating a crossover design. The study will assess garment effectiveness, tolerance, patient satisfaction, and compliance throughout these treatment phases. During the study, participants will have follow-up visits at six months and at the end of the twelve-month period after crossover. Researchers will monitor lower-limb volume changes, pain intensity, heaviness, numbness, pain characteristics, pressure pain threshold, quality of life, and compliance. Garment use adherence will be tracked through automated calls every two weeks during the entire follow-up. The total study duration for each participant is twelve months.

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