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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06438133
Other study ID # CIMON
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date December 2025

Study information

Verified date June 2024
Source Herlev and Gentofte Hospital
Contact Merete Celano Wittenkamp, MPH
Phone +93911784
Email merete.celano.wittenkamp@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
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.

Locations

Country Name City State
Denmark 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 Odense Region Of Southern Denmark

Sponsors (5)

Lead Sponsor Collaborator
Carsten Bogh Juhl Bispebjerg Hospital, Hvidovre University Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Edema reduction Assessed by Cimon sensor (in capacitans, pF) 14 days
Secondary Edema reduction Assessed by tape measurement (in cm), converted to volume by formula of truncated cone 14 days
Secondary Edema reduction Assessed by perometry (in ml) 14 days
Secondary Edema reduction Assessed by Dual energy X-ray Absorptiometry (in kg) 14 days
Secondary Symptoms related to chronic edema Self-reported pain, tension and heaviness 14 days
Secondary Physical Activity (PA) Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes) 14 days
Secondary Adverse events Any adverse events related to compression bandaging and the application of sensors 14 days
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