Lymphedema Clinical Trials

Find Lymphedema Clinical Trials Near You

Effectiveness of BoostEd COMpresson for the Treatment of Lower Limb Chronic Edema (BECOME): a Pragmatic Multi-centric Randomized Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 \<36

• Able to understand and follow instructions in Dutch

Locations
Other Locations
Belgium
Antwerp University Hospital
RECRUITING
Edegem
Ghent University Hospital
RECRUITING
Ghent
University Hospital Leuven
RECRUITING
Leuven
University of Antwerp
RECRUITING
Wilrijk
Contact Information
Primary
Nick Gebruers, PT, PhD, Professor
nick.gebruers@uantwerpen.be
+32496184346
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 160
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Universitaire Ziekenhuizen KU Leuven, University Hospital, Antwerp, University Hospital, Ghent, KU Leuven
Leads: Universiteit Antwerpen

This content was sourced from clinicaltrials.gov