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Completed

NCT Number: NCT07109674

Adjustable Compression Wraps (ACW) in Lymphedema

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University School of Physical Education

Krakow, Małopolska, 31-571, Poland

About this study

55 women after breast cancer treatment admitted to the Lymphedema Clinic and patients fulfilled the admission criteria - stage-II (according to ISL) lymphedema, ≥20% excess limb volumes, positive pitting skin sign, and absent signs of active cancer, venous thrombosis or previous compression were assigned into the experimental group with the adjustable compression wrap redcution kit, ACW - Group or the control with compression bandaging, CB-Group.

In the ACW reduction group, adjustable compression garments (typ circaid® reduction kit, Medi-Bayreuth) was also fitted based on individual limb measurements with ability to reduce size of garment as the limb volume decreases. The kit included a card with a color scale that allowed users to achieve the appropriate pressure of 20-30 mmHg. The next day, in order to refresh and moisturize the skin, these products were removed for a short period prior to the next therapeutic session. They were used for 24 hours.

In the CB group, multi-layer bandaging of the limb was performed using short stretch bandages with pads (Rosidal K, Lohmann & Raucher). At the beginning of bandaging, a cotton tube stockinet was placed on the arm, a layer of gauze was applied to the fingers and hand. A layer of foam padding (Lymphset: Lohmann & Raucher) was placed on the hand and wrapped around the arm. Three bandages of different sizes (8, 10, 12 cm in width) were placed around the limb with the first starting at the hand, the second at the wrist and the third beginning below the elbow. Sub-bandage pressure was measured via the Kikushime device (Kikgel, Ujazd Poland) on the dorsal part of the forearm, as well as on the arm, to ensure a pressure value within the range of 20-30 mmHg, comparable to pressure used in the compression system among the ACW Group. Bandages were removed for a short time before the therapeutic session the next day, as in the ACW-Group, and put on the next day. The exercise program including aerobic exercises of the upper limbs combined with deep breathing was performed in adjustable compression wraps or bandaging for 15 minutes in 1 session per day.

Measurements, including physical functioning, limb volumes and disease-related symptoms, 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.

Patients rated their physical functioning, disease-related symptoms, compression comfort and complications of compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Firstly, 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) and disease-related symptoms (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity), first without the tested compression and continued after 1 and 2 weeks using the compression device. 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 1 and 2 weeks 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 the first and second weeks in both groups.

Treatment in both groups lasted 10 days (2 weeks, Monday to Friday). In the first week, all patients were treated by 2 experienced physiotherapists and educated in applying adjustable compression wraps (ACW reduction group) or self-bandaging (CB group). During the 2nd week, the use of ACW and CB was continued by the patients themselves at home. Patients were asked to maintain the adjustable compression wraps or compression bandaging even during the weekend (Saturday and Sunday).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Device

inelastic compression during intensive phase of physical therapy

Other names: compression therapy

Comparison of inelastic compression efficiency

Device

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

Primary outcomes

  1. The assessment of limb volume

    Time frame: 14 months

    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.

  2. The assessment of physical functioning

    Time frame: 14 months

    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.

  3. The assessment of disease - related symptoms

    Time frame: 14 months

    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.

  4. The assessment of compression comfort

    Time frame: 14 months

    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.

Sponsors and collaborators

Lead sponsor

University School of Physical Education, Krakow, Poland

Other

Registry information

Official study title

Inelastic Compression With a High Stiffness Index in Breast Cancer-related Lymphedema: A Prospective Case - Control Study

Acronym: ACW

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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