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CompletedNCT02857621Updated Aug 16, 2017

Evaluation of Pressure Applying Efficiency in Multi-Layer Bandaging

An observational study in Lymphedema, sponsored by Assuta Hospital Systems. Completed at 1 site in Israel. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by Assuta Hospital Systems · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
37
Sex
All
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Study summary

Lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid in interstitial spaces. It is a progressive chronic disease and without appropriate management may result in serious complications. In Israel, patients are referred to physiotherapists certified in treatment for lymphedema. According to the International Society of Lymphology (ISL) the best treatment is a holistic, multidiscipline approach. Amongst the different methods of lymphedema management, the use of compression is the only treatment that has shown to be effective in randomized controlled trials.

The ISL recommends that patients with lymphedema in the lower limb ought to bandage their leg with multi-layer bandaging on a daily basis for a period of two to four weeks. A new classification system for compression bandages was recommended; pressure of \<20 mmHg was categorized as mild, 20-40 mmHg as medium, 40-60 mmHg as strong and ≥60 mmHg as very strong. In patients with leg edema, bandages with strong pressure were shown to be the most effective. However, in the presence of a venous ulcer on a lymphatic leg, pressure between 35 and 45 mmHg is the widely accepted range for sufficient and safe compression. The use of measurement instruments is currently the only realistic method for determining the actual pressure achieved beneath the bandage. However, it is neither economical nor feasib¬le nor is it realistic in terms of time.

Recent studies show that many healthcare professionals use inadequate sub-bandage pressure. No study so far has focused on therapists that are trained in lymphatic treatment. In spite of correct pressure bandaging importance, the question whether physiotherapists succeed in correctly applying it is left unanswered. The main purpose of this study is to evaluate the pressure applying efficiency in multi-layer bandaging among physiotherapists in Israel who treat lymphedema.

34 physiotherapists trained in lymphatic treatment will be recruited for this research. Each volunteer will receive a questionnaire concerning their self-perceived competence in the application of compression bandages. Afterwards, two practical trials will be held a week apart in which the subjects will be asked to apply bandages using strong and medium pressure. Using PicoPress®, pressure will be measured directly after bandaging and two hours later. Our hypothesis is that the majority of therapists will properly apply medium or strong pressure on the lower limbs.

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Conditions studied

  • Lymphedema

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03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's enrollment of 37 is below the median of 106 across 144 observational studies indexed under Lymphedema.

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Lead sponsor

Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Physical Therapists who have been specifically trained in Lymphatic therapy and have administered these treatments in the past two years.

Inclusion criteria

  • Physical Therapists trained in Lymphatic treatments

Exclusion criteria

Exclusion Criteria:

  • Have not treated a Lymphatic patient in the past two years
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
37 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Sub-bandage pressure

    Resting pressure will be measured directly after bandaging and two hours later using a PicoPress® measurement device.

    Time frame: Two hours

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Study locations

1 site
  • Maccabi Healthcare Services
    Bat Yam, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02857621
Lead sponsor
Assuta Hospital Systems
Collaborators
Maccabi Healthcare Services, Israel, University of Haifa
Responsible party
Sponsor
First posted
Aug 5, 2016
Start date
Aug 2016
Primary completion
Apr 23, 2017
Completion
Apr 23, 2017
Last update
Aug 16, 2017

Study contacts

Woldman Anat, BPT
study director · Physical Therapist at Maccabi HMO

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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