Boosted Compression for Lower Limb Chronic Edema

NCT07708662 | Recruiting DMC

• 1 other identifier: T000725N
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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. 1.the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and
2. 2.the non-inferiority of boosted compression in maintaining reduced edema volume during the maintenance phase assessed at 1y of follow-up.

Conditions

Chronic Edema; Lymphedema

Keywords

RCT; Pragmatic; Chronic Edema; Lower Limb; Lymphedema; compression therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Cost-effectiveness assessment with an adapted iMTA medical constumption questionnaire and IMTA Productivity cost questionnaire

  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)

  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)

  End intensive treatment phase until data saturation

• Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema

  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)

  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).

Study Arms (2)

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.

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.

Other: Conservative edema treatment with boosted compression therapy

Interventions

Conservative edema treatment (complex decongestive therapy) OTHER

Conservative decongestive edema treatment with a single application of the compression bandage/day.

Also known as: complex decongestive treatment, complex physical therapy

Standard chronic edema care with a single compression bandage application

Conservative edema treatment with boosted compression therapy OTHER

Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)

Also known as: Complex physical therapy with boosted compression therapy

Chronic edema care with boosted compression bandage applications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Ghent: collaborator
• University Hospital, Antwerp: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• KU Leuven: collaborator

Study Sites (4)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

University of Antwerp

Wilrijk, Antwerp, 2610, Belgium

RECRUITING

University Hospital Leuven

Leuven, Brabant, 3000, Belgium

RECRUITING

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

RECRUITING

Related Publications (5)

• 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.

  PMID: 18336577 BACKGROUND

• 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.

  PMID: 10870068 BACKGROUND

• 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.

  PMID: 23641263 BACKGROUND

• 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.

  PMID: 34463159 BACKGROUND

• 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.

  PMID: 22233613 BACKGROUND

Related Links

• Study website
• Research consortium website

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Nick Gebruers, PT, PhD, Professor

CONTACT

+32496184346; nick.gebruers@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Multicentric randomized pragmatic trial design

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)