Chronic EdemaBECOMENCT07708662
Boosted Compression for Lower Limb Chronic Edema
A study testing Conservative edema treatment (complex decongestive therapy) and Conservative edema treatment with boosted compression therapy in people with Chronic Edema and Lymphedema, run by Universiteit Antwerpen at 4 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Edema, Lymphedema
- What is being tested?
- Conservative edema treatment (complex decongestive therapy) and Conservative edema treatment with boosted compression therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesBelgium
- Study dates
- Jun 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium4 sites, 4 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Gaëtane Stassijns, MD, PhD, professor, +328213000, gaetane.stassijns@uza.be
- Recruiting
Ghent University Hospital
Ghent, East Flanders, 9000
Caren Randon, MD, PhD, professor, +329332 21 11, carend.randon@uzgent.be
- Recruiting
University Hospital Leuven
Leuven, Brabant, 3000
Nele PT, PhD, Professor, Devoogdt, +3216 33 22 11, nele.devoogdt@kuleuven.be
- Recruiting
University of Antwerp
Wilrijk, Antwerp, 2610
Nick Gebruers, PT, PhD, Professor, 0496184346, nick.gebruers@uantwerpen.be
About this study
Official title: 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.
Read more
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:
- the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and
- 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.
Read the 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.
- Conditions
- Chronic Edema, Lymphedema
- Being tested
- Conservative edema treatment (complex decongestive therapy), Conservative edema treatment with boosted compression therapy
- Keywords
- RCT, Pragmatic, Chronic Edema, Lower Limb, Lymphedema, compression therapy
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative edema treatment (complex decongestive therapy)Other
Also called complex decongestive treatment, complex physical therapy
Conservative decongestive edema treatment with a single application of the compression bandage/day.
Conservative edema treatment with boosted compression therapyOther
Also called Complex physical therapy with boosted compression therapy
Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)
| Study group | Role | What they receive |
|---|---|---|
| Standard chronic edema care with a single compression bandage application | Active comparator | 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. Receives: Other: Conservative edema treatment (complex decongestive therapy) |
| Chronic edema care with boosted compression bandage applications | Experimental | 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. Receives: Other: Conservative edema treatment with boosted compression therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric randomized pragmatic trial design
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, KU Leuven
- Responsible party
- Principal investigator, Nick Gebruers, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708662
- Sponsor's protocol ID
- T000725N
- Other IDs
- T000725N
- Acronym
- BECOME
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 18336577Badger 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.
PubMed 10870068Partsch 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.
PubMed 23641263Gebruers 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.
PubMed 34463159Partsch 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.
PubMed 22233613
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of BoostEd COMpresson for the Treatment of Lower Limb Chronic Edema (BECOME): a Pragmatic Multi-centric Randomized Trial
- ClinicalTrials.gov ID
- NCT07708662
- Acronym / sponsor ID
- BECOME / T000725N
- Conditions
- Chronic Edema, Lymphedema
- Keywords
- RCT, Pragmatic, Chronic Edema, Lower Limb, Lymphedema, compression therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, KU Leuven
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric randomized pragmatic trial design
| Arm | Type | Receives |
|---|---|---|
| Standard chronic edema care with a single compression bandage application | Active comparator | Other: Conservative edema treatment (complex decongestive therapy)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. |
| Chronic edema care with boosted compression bandage applications | Experimental | Other: Conservative edema treatment with boosted compression therapyThe patients will recieve complex decongestive therapy (Skin care + lymph drainage + compression bandage as 3 applications/day + exercises) followed by a maintenance phase of 1year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative edema treatment (complex decongestive therapy)Also: complex decongestive treatment, complex physical therapyConservative decongestive edema treatment with a single application of the compression bandage/day. | Other | Standard chronic edema care with a single compression bandage application |
| Conservative edema treatment with boosted compression therapyAlso: Complex physical therapy with boosted compression therapyConservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage) | Other | Chronic edema care with boosted compression bandage applications |
Primary outcome
Change of edema volume during the intensive treatment phase and maintenance phase.
Time frame: 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 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.
Number of days to obtain non-pitting state (with pitting test) during intensive phase
Time frame: 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).
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.
Change of water content in tissue (with TDC/PWC) during the intensive treatment phase and maintenance phase.
Time frame: 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).
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.
9 secondary outcomes
Cost-effectiveness assessment with an adapted iMTA medical constumption questionnaire and IMTA Productivity cost questionnaire
Time frame: 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)
Time frame: 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)
Time frame: End intensive treatment phase until data saturation
Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 18336577Damstra 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.
- Background: PubMed 10870068Badger 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.
- Background: PubMed 23641263Partsch 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.
- Background: PubMed 34463159Gebruers 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.
- Background: PubMed 22233613Partsch 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.
- Study websiteLink provided by the sponsor.
- Research consortium websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative edema treatment (complex decongestive therapy) and Conservative edema treatment with boosted compression therapy in people with Chronic Edema and Lymphedema, run by Universiteit Antwerpen at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nick Gebruers, PT, PhD, Professor (+32496184346, nick.gebruers@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of edema volume during the intensive treatment phase and maintenance phase. (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07708662, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.