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

Recruiting

• Conditions: Venous Insufficiency; Lymphedema of Leg; Compression; Vein; Digital Technology
• Interventions: Other: CIMON; Other: Sens Motion

• Registration Number: NCT06438133
• Lead Sponsor: Carsten Bogh Juhl

Brief 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.

Study Timeline

• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Study First Posted: 2024-05-31
• Study Start: 2024-06-10
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic edema of the lower limbs	Sens Motion	Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.
Patients with chronic edema of the lower limbs	CIMON	Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.

Primary Outcome Measures

Name	Time	Method
Edema reduction	14 days	Assessed by Cimon sensor (in capacitans, pF)

Secondary Outcome Measures

Name	Time	Method
Edema reduction	14 days	Assessed by Dual energy X-ray Absorptiometry (in kg)
Physical Activity (PA)	14 days	Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes)
Adverse events	14 days	Any adverse events related to compression bandaging and the application of sensors
Symptoms related to chronic edema	14 days	Self-reported pain, tension and heaviness

Trial Locations

Locations (5)

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 Svendborg; 🇩🇰 Odense, Region of Southern Denmark, Denmark