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.

Primary

The first objective of this project is to demonstrate the possibility to reduce the duration of the intensive treatment phase when the boosted compression therapy is used compared to standard care of 1 application. Therefore, the primary objective is to evaluate the efficacy of boosted compression bandaging (3 applications/day applied by the patient, physiotherapist, home nurse, partner, family member…) administered during the intensive treatment phase of treatment for lower limb chronic edema in real-world clinical settings, relative to the current standard care (1 applications/day applied by the physiotherapist).

However, an effective treatment of chronic edema can only be achieved when the reduction in edema volume is maintained after the intensive treatment phase. As such, the investigators also need to demonstrate that during follow-up, which is called the maintenance phase, the edema reduction is maintained in the same way or even better in comparison to the current standard maintenance phase. Therefore, in the second objective, the investigators will assess whether in the long term the edema reduction is maintained in the same way between standard CDT and after boosted compression (non-inferiority statement).

The primary outcome measure is the number of days to obtain non-pitting state during intensive phase, edema volume (with circumferences measurements) and water content in tissue (with tissue dielectric constant) at the start and end of the intensive phase and after 4 months, 6 months and 1 year of follow-up in the maintenance phase.

Secondary

Treatment effectiveness requires patient adherence and acceptability. Clinical experience reveals multiple implementation barriers to compression bandaging: physical discomfort (tightness, heat, bulk affecting clothing/footwear), procedural burden (time-intensive application), financial barriers (non-reimbursed costs, need for multiple sets), and social acceptability concerns (cosmetic appearance limiting public/social use). These barriers collectively reduce real-world treatment fidelity. A first secondary objective examines whether a time-limited boosted compression protocol is acceptable and people adherence to it.

Optimization of the intensive phase has the potential to improve cost-effectiveness. Boosted compression bandaging therapy is likely to reduce the treatment days, and potentially even so treatment hours, which have implications for direct and indirect costs. In the end, also the effect on Quality of Life (QoL) should be considered and each treatment arm translated in quality-adjusted life years (QALY) gained. Data on costs and effects measured for each trial-participant will allow to perform a trial-based economic evaluation. The physical therapy related standard tariffs and treatment protocol will serve as the starting point. In addition, therapy-related additional costs and overall time spend on treatment will be collected. The primary outcome of interest is the incremental cost-effectiveness ratio (ICER), which is calculated by dividing the difference in mean costs between study groups by the difference in health-related effects. If there are negative costs (i.e. savings) and/or health effects, the net monetary benefit approach will be adopted to evaluate the cost-effectiveness of the intervention. The proposed health economic evaluation is informative from the public healthcare payer and societal perspective by including both the direct and indirect, medical and non-medical costs. As such, in the second secondary objective, the investigators will study the cost-effectiveness of boosted compression bandaging therapy in comparison with the current standard care of CDT.

The third secondary objective includes considering the baseline characteristics and the follow-up results will allow to define predictive factors for the success or failure of this treatment in the intensive treatment phase and 1 year of follow-up in the maintenance phase. This will allow to create a risk assessment for patients starting a new treatment for chronic edema.

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.

Data will be shared' as open as possible and as closed as needed', according to the FAIR principles. Data will be made available upon reasonable request.

Due to the nature of the intervention, blinding of the patients and most of the study team members is impossible. However, the assessors will be blinded to group allocation limiting the possibility to any assessment bias. To fulfill the prerequisite of blinded assessments participants will be instructed not to discuss any details of their treatment with the assessors.