Adjustable Compression Wraps (ACW) in Lymphedema

NCT07109674 | Completed

• 1 other identifier: 345/BS/IRK/2024
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Compression therapy based on multilayer compression bandaging and com pression garment use remains the most efficient component of complex physical therapy (CPT) in lymphedema treatment. The proper self-application of compression bandages is generally considered as problematic. Adjustable compression wraps (ACW) have been proposed as an alternative to the commonly used short-stretch bandages for lymphedema. These systems allow easy application and removal for patients. They have been tested in patients with vascular disorders of the lower limbs and can be considered in breast cancer survivors with upper-limb lymphedema. The objective of this study was to compare the effectiveness, physical functioning and comfort of 2 types inelastic compression: adjustable compression wrap (reduction) and multi-layer compression bandaging at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors.

Conditions

Lymphedema; Lymphedema Arm; Breast Cancer

Keywords

breast cancer survivors; compression therapy; adjustable compression wrap; compression bandaging

Outcome Measures

Primary Outcomes (4)

• The assessment of limb volume

  Measurements including limb volumes were performed before the intervention, and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.

  14 months

• The assessment of physical functioning

  Patients rated their physical functioning of the affected limb on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. The patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) before and after treatment in both groups.

  14 months

• The assessment of disease - related symptoms

  Patients rated their disease-related symptoms based on the International Compression Club (ICC) Questionnaire - Part for Patients on the Number Rating (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity) before the intervention and after treatment in both groups.

  14 months

• The assessment of compression comfort

  Patients rated their comfort and complications related to compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after treatment in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after treatment in both groups.

  14 months

Study Arms (2)

Adjustable compression wrap-reduction kit

EXPERIMENTAL

The objective of this study was to compare the effectiveness on volume reduction, physical functioning and comfort of inelastic compression: adjustable compression wrap (reduction) at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors

Device: adjustable compression device (type circaid® reduction kit, Medi-Bayreuth)

Compression bandaging

ACTIVE COMPARATOR

text

Device: Comparison of inelastic compression efficiency

Interventions

adjustable compression device (type circaid® reduction kit, Medi-Bayreuth) DEVICE

inelastic compression during intensive phase of physical therapy

Also known as: compression therapy

Adjustable compression wrap-reduction kit

Comparison of inelastic compression efficiency DEVICE

The effect of compression on volume reduction, physical functioning, disease-related symptoms and comfort

Compression bandaging

Eligibility Criteria

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

You may qualify if:

• stage-II of lymphedema (according to ISL)
• ≥20% excess limb volumes
• positive pitting skin sign
• absent signs of active cancer
• absent of venous thrombosis

You may not qualify if:

• active cancer during oncological treatment
• using compression
• stage-I of lymphedema (according to ISL)
• \< 20 % excess limb volumes

Sponsors & Collaborators

• University School of Physical Education, Krakow, Poland: lead

Study Sites (1)

University School of Physical Education

Krakow, Małopolska, 31-571, Poland

Location

Related Publications (2)

• Ochalek K, Kurpiewska J, Gradalski T. Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study. Biology (Basel). 2023 Mar 31;12(4):534. doi: 10.3390/biology12040534.

  PMID: 37106735 BACKGROUND

• Pujol-Blaya V, Salinas-Huertas S, Catasus ML, Pascual T, Belmonte R. Effectiveness of a precast adjustable compression system compared to multilayered compression bandages in the treatment of breast cancer-related lymphoedema: a randomized, single-blind clinical trial. Clin Rehabil. 2019 Apr;33(4):631-641. doi: 10.1177/0269215518821785. Epub 2019 Jan 4.

  PMID: 30607986 BACKGROUND

Related Links

• Effectiveness of a precast adjustable compression system compared to multilayerd compression bandaging in the treatment of breast cancer-related lymphedema

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison the physiotherapeutical intervention in breast cancer surivors

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: August 7, 2025
• Study Start: January 3, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after publication start date: 01.10.2025 end date: 31.12.2025
• Access Criteria: IPD will be available to reviewers of the manuscript submitted for publication.

Locations

PL (1)