Non-inferiority of Compression Bandage Alone in Lower Extremity Lymphedema Management

NCT06750679 | Completed

• 1 other identifier: BAIBU-FTR-ED-004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphedema is much more than a disease with edema. Impaired lymphatic drainage triggers adipose tissue deposition and fibrosis. Fibrosis causes lymphatic vessel dysfunction. Therefore, treatment of fibrosis is important. The gold standard of treatment for lymphedema is complex decongestive physiotherapy. In this treatment method consisting of two phases and four components in each phase, each component has its own effect. Compression is the main component of these components in terms of edema reduction. The effect of manual lymph drainage, another component, on edema and fibrosis is contradictory. Although there are studies evaluating fibrosis in lower extremity lymphedema in the literature, there is no study evaluating the effect of treatment on fibrosis and comparing two different methods evaluating fibrosis. Research question: What is the effect of manual lymph drainage in addition to compression therapy on fibrosis, edema, skin and subcutaneous tissue thickness, and quality of life. The primary aim of this study was to evaluate the effect of manual lymph drainage applied as an adjunct to compression therapy on fibrosis in individuals with lower extremity lymphedema. The secondary aim of the study was to evaluate the effect of manual lymph drainage in addition to compression therapy on skin and subcutaneous tissue thickness, edema and quality of life. Patients with lower extremity lymphedema will be randomly allocated to the compression group and manual lymph drainage + compression group. Fibrosis in the tissues of the individuals will be evaluated by ultrasound and SkinFibrometer device, skin and subcutaneous tissue thickness will be evaluated by ultrasound, edema perimeter measurement will be converted to volume, and quality of life will be evaluated by Lymphedema Quality of Life Questionnaire-Lower Extremity before and after treatment. Individuals will be randomized to either 20 sessions of compression bandage or 20 sessions of compression bandage with manual lymph drainage. Both groups will include skin care and exercise components of complex decongestive physiotherapy. This study will provide important data on whether manual lymph drainage is clinically necessary in the treatment of lower limb lymphedema.

Conditions

Lower Extremity Lymphedema

Keywords

lower extremity lymphedema; fibrosis; manual lymphatic drainage; Complex decongestive physiotherapy; Quality of life

Outcome Measures

Primary Outcomes (1)

• Edema Assessment

  Edema will be assessed by circumference measurements with the patient in a supine position. Measurements will start 10 cm from the heel. Along the lateral aspect of the leg, marks will be made at 8 cm intervals, and circumference measurements will be taken at these points along the extremity. Using a non-elastic tape measure 1 cm in width, measurements will be conducted without compressing the tissue and ensuring the ends of the tape do not overlap. Measurements will be recorded in centimeters. This process will be performed bilaterally. The recorded circumferences will then be converted into volume using the truncated cone formula, as extremities are considered geometrically as truncated cones for this calculation.

  Baseline, four week later

Secondary Outcomes (2)

• Assessment of Skin and Subcutaneous Tissue Thickness

  Baseline and four week later

• Assessment of Fibrosis Using the SkinFibroMeter

  Baseline and four week later

Study Arms (2)

Compression Group

ACTIVE COMPARATOR

In compression therapy, multicomponent inelastic compression bandages bandages will be applied (Misra et al., 2023). The individual will be fitted with a stockinet beforehand. Fingers will be bandaged. Then, the extremity will be cylindricalized with a cotton roller or sponge. Subsequently, the foot and ankle will be bandaged using a 6 cm short-stretch bandage. An 8 cm short-stretch bandage will be applied starting from the foot and progressing upward above the ankle. A 10 cm short-stretch bandage will then be applied, beginning at the ankle and wrapping upward. The next bandages will be wrapped upwards starting from the places where the pressure is low. The compression bandage will remain on the patient's leg for approximately 23 hours. When the individual arrives the next day, the bandage will be removed and reapplied. The application time of the inelastic bandage is approximately 20-30 minutes. Compression therapy will be applied 5 days a week for 4 weeks (20 sessions)

Other: Manual lymphatic drainage added to compression

Compression+MLD Group

EXPERIMENTAL

Participants in the group receiving MLD in addition to compression therapy will undergo a 30-40-minute MLD session to facilitate the entry of interstitial fluid into lymphatic capillaries and enhance lymph propulsion (Misra et al., 2023). The MLD will be performed with gentle pressure of approximately 30-40 mmHg, ensuring the skin and connective tissue move together without sliding on the skin. After the MLD session, a multilayer bandaging will be applied to the extremity, which the patient will wear for approximately 23 hours. The bandage will be removed and reapplied during the patient's visit the following day. The combined therapy of compression and MLD will be administered five days a week for four weeks (20 sessions in total). Each session will last approximately 50-70 minutes.

Other: Compression bandage

Interventions

Compression bandage OTHER

A multicomponent inelastic compression bandage will be applied to the patient. Skin care and simple exercises will be added to intervention

Compression+MLD Group

Manual lymphatic drainage added to compression OTHER

Manual lymphatic drainage will be added to multicomponent inelastik compression bandage, skin care and simple exercises

Compression Group

Eligibility Criteria

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

You may qualify if:

• According to the criteria of the International Society of Lymphology Stage 2 and 3 lower extremity LE to volunteer to participate in the study
• To be between the ages of 18-80
• LE involving the entire lower extremity

You may not qualify if:

• Acute deep vein thrombosis
• Acute infection
• Peripheral arterial disease in the lower extremity
• To have systemic diseases that may cause edema other than LE (renal failure, liver failure, heart failure, etc.)
• Chronic venous insufficiency
• Allergy to materials used in treatment
• Mental/cognitive problems that will affect cooperation
• Loss of sensation
• Presence of scleroderma in the treatment area
• Active cancer
• Radiogenic fibrosis in the treatment area

Sponsors & Collaborators

• Abant Izzet Baysal University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Merkez, 14030, Turkey (Türkiye)

Location

Related Publications (27)

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MeSH Terms

Conditions

Fibrosis

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Non inferiority study

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)