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

Carsten Bogh Juhl

Status: Completed

Conditions: Compression; Vein; Venous Insufficiency; Digital Technology; Lymphedema of Leg

Treatments: Other: Sens Motion; Other: CIMON

Study type: Observational

Funder types: Other

Identifiers

NCT06438133

CIMON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Patients with chronic edema of the lower limbs

Description:

Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.

Treatment:

Other: CIMON

Other: Sens Motion