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Completed

NCT Number: NCT06438133

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

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.

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Key information

Conditions

Compression; Vein Cardiovascular Diseases Digital Technology Lymphedema of Leg Vascular Diseases Venous Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, Frederiksberg Bispebjerg Hospital, Bispebjerg, Capital Region, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIMON

Other

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

Other

The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.

Primary outcomes

  1. Edema reduction

    Time frame: 14 days

    Assessed by Cimon sensor (in capacitans, pF)

Secondary outcomes

  1. Edema reduction

    Time frame: 14 days

    Assessed by tape measurement (in cm), converted to volume by formula of truncated cone

  2. Edema reduction

    Time frame: 14 days

    Assessed by perometry (in ml)

  3. Edema reduction

    Time frame: 14 days

    Assessed by Dual energy X-ray Absorptiometry (in kg)

  4. Symptoms related to chronic edema

    Time frame: 14 days

    Self-reported pain, tension and heaviness

  5. Physical Activity (PA)

    Time frame: 14 days

    Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes)

  6. Adverse events

    Time frame: 14 days

    Any adverse events related to compression bandaging and the application of sensors

Sponsors and collaborators

Lead sponsor

Carsten Bogh Juhl

Other

Collaborators

  • Bispebjerg Hospital
  • Copenhagen University Hospital, Hvidovre
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

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

Acronym: CIMON

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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