Boosted Compression for Lower Limb Chronic Edema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversiteit Antwerpen
About this trial
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
Qualifiers
Patients suffering from chronic edema ( > 3 months) of the lower extremity with a positive pitting sign and a conservative treatment is prescribed.
BMI is <36
Able to understand and follow instructions in Dutch
Disqualifiers
All treatable causes of chronic edema, such as hormonal disturbances (e.g. thyroid dysfunction), protein abnormalities (especially Albumin), cardiac insufficiency, nephrological conditions, drug-induced edema or peripheral arterial disease.
Peripheral arterial disease (ABI < 0.55)
The patient is allergic for one of the products we use during the treatment, and no alternative is available
The patient has wounds at the level of the treated edema zone.
Trial design
Treatments tested in this trial
- Conservative edema treatment (complex decongestive therapy)
- Conservative edema treatment with boosted compression therapy
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universiteit Antwerpen
Lead sponsor
University Hospital, Ghent
Collaborator
University Hospital, Antwerp
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
KU Leuven
Collaborator
Source ClinicalTrials.gov