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