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

Venous Insufficiency Clinical Trial

— CIMON  

Official title:

Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438133
• Other study ID #: CIMON
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Compression; Vein
• Lymphedema
• Lymphedema of Leg
• Venous Insufficiency

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