NCT06438133

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Carsten Bogh Juhl · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.
OTHER	Sens Motion	The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.

Timeline

• Start date: 2024-06-10
• Primary completion: 2025-12-18
• Completion: 2025-12-18
• First posted: 2024-05-31
• Last updated: 2025-12-26

Locations

5 sites across 1 country: Denmark