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Recruiting NCT07708662

Boosted Compression for Lower Limb Chronic Edema

Conditions: Chronic Edema, Lymphedema

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Universiteit Antwerpen

Location: Antwerp University Hospital Edegem Antwerp

Summary

Patients: Patients targeted in this proposal comprise individuals afflicted by chronic edema/lymphedema of the lower limbs. Intervention: The intervention entails the incorporation of boosted compression alongside standard care during the intensive treatment phase. Boosted compression involves thrice-daily re-application of a multicomponent short stretch compression bandage, aimed at enhancing the efficacy of compression therapy within edema treatment. Comparison: Comparison will be made between the experimental intervention (boosted compression) and the prevailing standard edema treatment, which adheres to the complex decongestive therapy as stipulated by healthcare services, utilizing a single daily application of compression bandage. Standard care is administered under the supervision of trained physical therapists, specialized in edema treatment. Outcome: Primary outcomes encompass the determination of: 1. the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and 2. the non-inferiority of boosted compression in maintaining reduced edema volume during the maintenance phase assessed at 1y of follow-up. Secondary outcomes encompass assessments of: Quality of Life, acceptance, and adherence to boosted compression, alongside evaluations of time and cost-effectiveness associated with its implementation.

Eligibility Criteria

Inclusion criteria: * Patients suffering from chronic edema ( \> 3 months) of the lower extremity with a positive pitting sign and a conservative treatment is prescribed. -≥ 18 years old * BMI is \

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Source: ClinicalTrials.gov (NCT07708662). StuddyBuddy aggregates publicly available trial information.