NCT07708662 Boosted Compression for Lower Limb Chronic Edema
| NCT ID | NCT07708662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiteit Antwerpen |
| Condition | Chronic Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-06 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2026-06 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: * 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 Exclusion criteria: * 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. * The patient is currently receiving treatment within the convention "lymfoedeem" according to the Belgian Health insurance (RIZIV-INAMI). * The patient is not able to give written consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07708662 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07708662 currently recruiting?
Yes, NCT07708662 is actively recruiting participants. Contact the research team at nick.gebruers@uantwerpen.be for enrollment information.
Where is the NCT07708662 trial being conducted?
This trial is being conducted at Edegem, Belgium, Wilrijk, Belgium, Leuven, Belgium, Ghent, Belgium.
Who is sponsoring the NCT07708662 clinical trial?
NCT07708662 is sponsored by Universiteit Antwerpen. The trial plans to enroll 160 participants.