Controlled, comparative study of relation between volume changes and interface pressure under short-stretch bandages in leg lymphedema patients.
Robert J Damstra, Els R Brouwer, Hugo Partsch
https://pubmed.ncbi.nlm.nih.gov/18336577/Actively Recruiting
Led by Universiteit Antwerpen · Updated on 2026-07-16
160
Participants Needed
4
Research Sites
30 weeks
Total Duration
Researchers are evaluating a new approach to treating chronic edema or lymphedema of the lower limbs. This trial aims to compare boosted compression therapy, which involves applying a multicomponent short stretch compression bandage three times daily, with the standard care of a single daily compression bandage application. The study focuses on whether boosted compression can reduce treatment duration and maintain edema reduction over time. Participants will be randomly assigned to either the experimental group receiving boosted compression therapy or the control group receiving standard complex decongestive therapy including skin care, lymph drainage, compression bandaging, and exercises. The intensive treatment phase uses these therapies, followed by a maintenance phase lasting one year to monitor long-term effects. The boosted compression bandage can be applied by the patient or caregivers, while standard therapy is applied once daily by a physiotherapist. During the study, participants will be assessed regularly for changes in edema volume, tissue water content, and the time needed to achieve a non-pitting edema state. Additional evaluations will include quality of life, patient acceptance, adherence to treatment, and cost-effectiveness. Questionnaires, diaries, and clinical measurements will be collected throughout the intensive and maintenance phases, with follow-up visits up to one year after treatment completion.
CONDITIONS
Boosted Compression for Lower Limb Chronic Edema
N
Nick Gebruers, PT, PhD, Professor
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Universiteit Antwerpen
Lead Sponsor
University Hospital, Ghent
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration until non-pitting edema state is achieved
Participants receive complex decongestive therapy including skin care, lymph drainage, exercises, and compression bandaging either once daily (standard care) or three times daily (boosted compression).
Regular visits during treatment
Duration - 12 months
Participants continue follow-up for up to one year to monitor edema volume and maintain swelling reduction after intensive treatment.
Follow-up assessments at 1, 4, 6, and 12 months
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Robert J Damstra, Els R Brouwer, Hugo Partsch
https://pubmed.ncbi.nlm.nih.gov/18336577/Hugo Partsch
https://pubmed.ncbi.nlm.nih.gov/23641263/C M Badger, J L Peacock, P S Mortimer
https://pubmed.ncbi.nlm.nih.gov/10870068/H Partsch, R J Damstra, G Mosti
https://pubmed.ncbi.nlm.nih.gov/22233613/Nick Gebruers, Jeroen M H Hendriks, Wiebren Tjalma...
https://pubmed.ncbi.nlm.nih.gov/34463159/Universiteit Antwerpen
Lead Sponsor
University Hospital, Ghent
Collaborating Sponsor