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Boosted Compression for Lower Limb Chronic Edema

NCT07708662 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

  • Chronic Edema
  • Lymphedema

Interventions

OTHER

Conservative edema treatment (complex decongestive therapy)

Conservative decongestive edema treatment with a single application of the compression bandage/day.

OTHER

Conservative edema treatment with boosted compression therapy

Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • University Hospital, Antwerp

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • KU Leuven

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2029-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708662 on ClinicalTrials.gov