Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs

NCT ID: NCT06438133

Last Updated: 2025-12-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2025-12-18

Brief Summary

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Patients with chronic edema of the lower limb referred to compression bandaging in a hospital setting will be invited to participate in the validation study of a novel sensor (CIMON), which have been developed for assessing the effect of compression bandaging. Participants will have the sensor applied to the lower limb before initiation of compression bandaging and will receive usual compression treatment according to severity of the edema and usual practice at the treatment site. Duration of participation is 14 days.

Detailed Description

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The CIMON sensor is developed with the purpose of monitoring the effectiveness of compression bandaging (CB) in patients with chronic edema by application to the widest circumference of the calf. CIMON measures the difference in capacitance by stretching the circumferential sensor. Data from the sensor is transferred by Bluetooth technology to a secured webserver, where healthcare professionals can monitor the effect of compression bandaging.

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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Compression; Vein Venous Insufficiency Lymphedema of Leg Digital Technology

Keywords

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Compression therapy Compression bandaging Chronic edema Psychometrics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Sens Motion

The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic edema of the lower limb
* Referred to compression bandaging
* Circumference of widest point of the lower leg between 35-75 cm

Exclusion Criteria

* Wounds at the lower leg (at the widest circumference of the lower leg)
* Acute deep venous thrombosis in the leg
* Untreated cellulitis
* Severe heart- or kidneyfailure
* Severe peripheral neuropathy in the lower limbs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role collaborator

Carsten Bogh Juhl

OTHER

Sponsor Role lead

Responsible Party

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Carsten Bogh Juhl

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Department of Physiotherapy and Occupational Therapy, Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status

Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

Herlev, Capital Region, Denmark

Site Status

Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital

Hvidovre, Capital Region, Denmark

Site Status

Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg

Odense, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CIMON

Identifier Type: -

Identifier Source: org_study_id