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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency; Compression; Vein; Digital Technology; Lymphedema of Leg
• Intervention / Treatment: Other: CIMON; Other: Sens Motion

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Bispebjerg, Capital Region, Denmark
      • Department of Dermatology, Frederiksberg Bispebjerg Hospital
    • Copenhagen, Capital Region, Denmark, 2100
      • Department of Physiotherapy and Occupational Therapy, Rigshospitalet
    • Herlev, Capital Region, Denmark, 2730
      • Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
    • Hvidovre, Capital Region, Denmark
      • Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark
      • Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic edema of the lower limbs; Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edema reduction	Assessed by Cimon sensor (in capacitans, pF)	14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carsten Bogh Juhl
• Collaborators: Odense University Hospital; Rigshospitalet, Denmark; Bispebjerg Hospital; Copenhagen University Hospital, Hvidovre
• Investigators: Study Chair: Carsten Bogh Juhl, Professor, Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): December 18, 2025
• Study Completion (Actual): December 18, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Psychometrics; Compression therapy; Compression bandaging; Chronic edema
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency
• Other Study ID Numbers: CIMON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No