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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Conservative edema treatment (complex decongestive therapy)
Other intervention
Conservative decongestive edema treatment with a single application of the compression bandage/day.
Conservative edema treatment with boosted compression therapy
Other intervention
Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: Standard chronic edema care with a single compression bandage applicationActive comparator 1 intervention

Group B: Chronic edema care with boosted compression bandage applicationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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).

2

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.

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).

3

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.

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).

Secondary outcomes

1

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.

Time frame

Assessed at the end of the intensive treatment phase/ at 6 months after the end of intensive treatment phase (maintenance phase).

2

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.

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

3

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

Time frame

End intensive treatment phase until data saturation

4

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.

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).

Boosted Compression for Lower Limb Chronic Edema

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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