Boosted Compression for Lower Limb Chronic Edema (BECOME)

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

Study Overview

• Status: Recruiting
• Conditions: Lymphedema; Chronic Edema
• Intervention / Treatment: Other: Conservative edema treatment (complex decongestive therapy); Other: Conservative edema treatment with boosted compression therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nick Gebruers, PT, PhD, Professor; Phone Number: +32496184346; Email: nick.gebruers@uantwerpen.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: Gaëtane Stassijns, MD, PhD, professor; Phone Number: +328213000; Email: gaetane.stassijns@uza.be
    • Wilrijk, Antwerp, Belgium, 2610
      • Recruiting
      • University of Antwerp
      • Contact: Nick Gebruers, PT, PhD, Professor; Phone Number: 0496184346; Email: nick.gebruers@uantwerpen.be
  • Brabant
    • Leuven, Brabant, Belgium, 3000
      • Recruiting
      • University Hospital Leuven
      • Contact: Nele PT, PhD, Professor, Devoogdt; Phone Number: +3216 33 22 11; Email: nele.devoogdt@kuleuven.be
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • Recruiting
      • Ghent University Hospital
      • Contact: Caren Randon, MD, PhD, professor; Phone Number: +329332 21 11; Email: carend.randon@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Conservative edema treatment (complex decongestive therapy); Conservative decongestive edema treatment with a single application of the compression bandage/day.; Other Names: complex decongestive treatment; complex physical therapy
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.	Other: Conservative edema treatment with boosted compression therapy; Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage); Other Names: Complex physical therapy with boosted compression therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of edema volume during the intensive treatment phase and maintenance phase.	Change in edema volume will be evaluated using circumferential measurements. Circumferences of both legs will be measured at 4-cm intervals. Limb volumes will be calculated from the circumference measurements, and changes in edema volume will be assessed.	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
Number of days to obtain non-pitting state (with pitting test) during intensive phase	The pitting status is assessed by putting pressure on the edematous area; when the pressure is released, a visual or palpable indentation needs to be present for a +pitting, otherwise it is -pitting.	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
Change of water content in tissue (with TDC/PWC) during the intensive treatment phase and maintenance phase.	The local tissue water is assessed at each study time point: baseline, at the end of the intensive treatment phase, and at 1, 6, and 12 months during the maintenance phase. Local tissue water will be measured using a lymphscanner or moisture meter. Tissue Direct Current will be used to assess the amount of water 2,5 mm underneath the skin at predetermined locations on both legs.	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness assessment with an adapted iMTA medical constumption questionnaire and IMTA Productivity cost questionnaire	Participants score cost-effectivess in terms of direct and indirect costs. The questionnaires are intended to provide an overview of the patient's background, household, and housing situation on the one hand, and the patient's health and work during the past four weeks on the other.	Assessed at the end of the intensive treatment phase/ at 6 months after the end of intensive treatment phase (maintenance phase).
Effect of compression and acceptance by patient (Dutch ICC-compression questionnaire)	The purpose of the ICC compression questionnaire is to evaluate the effect of different kinds of compression materials and systems and its acceptance and experience by the patient. The compression questionnaire can be used for longitudinal comparative studies. ICC patients is a questionnaire filled out by the patients assessing the use and comfort of compression bandages and/or garments. The score on each domain ranges between 0 (worst fysical functioning/ fewest disease-related symptoms) and 10 (best fysical functioning/ most severe disease-related symptoms). ICC PT is a questionnaire filled out by a therapist concerning the use of compression and describes the patient and the compression device/system. In addition, the therapist performs an evaluation of the covering of the limb by the compression on the one hand and an evaluation of the skin under the compression on the other hand.	Patients: Baseline/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/study completion at 12 months Therapist: baseline/end of intervention phase
Acceptance and adherence (qualitative research by interviews)	Some patient CFIR-informed interview domains by the study coordinator: Focus areas: experience with assigned compression approach, perceived benefits and challenges, daily life integration and adherence, comparison with previous treatments, healthcare system interactions, support from family/social networks. Some provider CFIR-informed interview by the study coordinator domains: Focus areas: experience delivering interventions, perceived patient responses (Mechanisms + Individual Characteristics), implementation challenges and facilitators, training and support needs, professional networks and communication, organizational support and resources	End intensive treatment phase until data saturation
Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema	The Dutch Lymph-ICF-LL is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life. Each question has to be scored on an 11-point scale (0 to 10). The anchor points for the physical and mental function domain and tasks/ household domain are 'not at all' and 'a lot'. Those for the mobility and life domain/ social life domain were 'very well' and 'not at all'. The total score on the LYMPH-ICF-LL is equal to the sum of the item scores divided by the total number of answered items. A higher score indicates a greater impact on the functioning in daily life related to lower limb lymphedema.	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
Health-related quality of Life (EQ 5D-5L) (Belgian)	The EQ-5D-5L and EQ VAS are used to calculate Quality-Adjusted Life Years (QALYs) based on the Belgian value set, enabling comparison of the intervention with other healthcare investments. Results can also be compared with edema- and compression-specific quality-of-life questionnaires. The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from no problems to extreme problems. The EQ VAS measures the patient's self-rated health on a visual analogue scale ranging from "the worst health you can imagine" to "the best health you can imagine," providing a quantitative measure of perceived health	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
Health monitor	The Health Monitor is a concise and accessible questionnaire. It was developed because everyone experiences health differently. The better your personal health experience is known, the more targeted the care team can be in supporting you. In addition to medical treatment, we believe it is important to tailor additional support to your individual situation. We use the Health Monitor for this purpose. The Health Monitor consists of two steps: Assessing your mental and physical health over the past four weeks.; Determining (if necessary) how we can improve your perception of health. Six items, scored on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), are used to assess perceived control (items 1, 3, and 5) and acceptance (items 2, 4, and 6). Scores for each domain are summed and divided by three. Based on a cut-off value of 5.0, patients are subsequently classified into a corresponding segment.	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
General self-efficacy scale	The general Self-efficacy Scale is a 10-item unidimensional questionnaire that assesses an individual's general confidence in their ability to cope with challenging or stressful situations. Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
International Physical Activity Questionnaire-Short Form	The IPAQ-SF is a 7-item self-report questionnaire that assesses open-ended questions surrounding individuals' last 7-day recall of physical activity. Higher values indicate higher levels of physical activity.	Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
Diary	The patient will complete a diary during the intensive and maintenance phase and return it at each measurement appointment. The diary will record adherence to the use of the compression bandage and garment, the content of physiotherapy sessions, and the follow-up of skincare, with a focus on reporting early adverse events.	During the intensive treatment phase and the maintenance phase until study completion of 1 year after the end of the intervention or intensive treatment phase.

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Universitaire Ziekenhuizen KU Leuven; KU Leuven; University Hospital, Ghent; University Hospital, Antwerp

Publications and helpful links

General Publications

• Damstra RJ, Brouwer ER, Partsch H. Controlled, comparative study of relation between volume changes and interface pressure under short-stretch bandages in leg lymphedema patients. Dermatol Surg. 2008 Jun;34(6):773-8; discussion 778-9. doi: 10.1111/j.1524-4725.2008.34145.x. Epub 2008 Mar 10.
• Badger CM, Peacock JL, Mortimer PS. A randomized, controlled, parallel-group clinical trial comparing multilayer bandaging followed by hosiery versus hosiery alone in the treatment of patients with lymphedema of the limb. Cancer. 2000 Jun 15;88(12):2832-7.
• Partsch H. Compression therapy: clinical and experimental evidence. Ann Vasc Dis. 2012;5(4):416-22. doi: 10.3400/avd.ra.12.00068. Epub 2012 Nov 15.
• Gebruers N, Hendriks JMH, Tjalma W, Verbelen H, Van Soom T, van Breda E, De Vrieze T. Pressure Curves, Static and Dynamic Stiffness of Different Two-Component Compression Systems for the Treatment of Chronic Edema of the Lower Limbs. Lymphat Res Biol. 2022 Jun;20(3):335-341. doi: 10.1089/lrb.2021.0016. Epub 2021 Aug 31.
• Partsch H, Damstra RJ, Mosti G. Dose finding for an optimal compression pressure to reduce chronic edema of the extremities. Int Angiol. 2011 Dec;30(6):527-33.

Helpful Links

• Study website
• Research consortium website

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Lymphedema; RCT; compression therapy; Lower Limb; Pragmatic; Chronic Edema
• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: T000725N (Other Grant/Funding Number: FWO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No