Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs
NCT ID: NCT06438133
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2024-06-10
2025-12-18
Brief Summary
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Detailed Description
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The study aims to assess the psychometric properties of the CIMON (reliability, validity and responsiveness) and assess the correlation between edema reduction and physical activity during compression bandaging.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with chronic edema of the lower limbs
Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.
CIMON
The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied.
Sens Motion
The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.
Interventions
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CIMON
The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied.
Sens Motion
The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.
Eligibility Criteria
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Inclusion Criteria
* Referred to compression bandaging
* Circumference of widest point of the lower leg between 35-75 cm
Exclusion Criteria
* Acute deep venous thrombosis in the leg
* Untreated cellulitis
* Severe heart- or kidneyfailure
* Severe peripheral neuropathy in the lower limbs
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Bispebjerg Hospital
OTHER
Odense University Hospital
OTHER
Copenhagen University Hospital, Hvidovre
OTHER
Carsten Bogh Juhl
OTHER
Responsible Party
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Carsten Bogh Juhl
Professor
Principal Investigators
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Carsten Bogh Juhl, Professor
Role: STUDY_CHAIR
Herlev and Gentofte Hospital
Locations
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Department of Dermatology, Frederiksberg Bispebjerg Hospital
Bispebjerg, Capital Region, Denmark
Department of Physiotherapy and Occupational Therapy, Rigshospitalet
Copenhagen, Capital Region, Denmark
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
Herlev, Capital Region, Denmark
Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital
Hvidovre, Capital Region, Denmark
Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg
Odense, Region Syddanmark, Denmark
Countries
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Other Identifiers
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CIMON
Identifier Type: -
Identifier Source: org_study_id