Boosted Compression for Lower Limb Chronic Edema

Sponsor
Universiteit Antwerpen
Study ID
NCT07708662
Status
Recruiting
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Conditions

  • Chronic Edema
  • Lymphedema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conservative edema treatment (complex decongestive therapy) — OTHER
    Conservative decongestive edema treatment with a single application of the compression bandage/day.
  • Conservative edema treatment with boosted compression therapy — OTHER
    Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard chronic edema care with a single compression bandage application
    The patients will recieve complex decongestive therapy (Skin care + lymph drainage + compression bandage as a single application/day + exercises followed by a maintenance phase of 1year.
  • Experimental: Chronic edema care with boosted compression bandage applications
    The patients will recieve complex decongestive therapy (Skin care + lymph drainage + compression bandage as 3 applications/day + exercises) followed by a maintenance phase of 1year.

Primary Outcome Measure

Change of edema volume during the intensive treatment phase and maintenance phase. [ Time Frame: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion). ]

Central Contacts

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