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

Last updated: February 27, 2025
Sponsor: Carsten Bogh Juhl
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Thrombosis

Vascular Diseases

Varicose Veins

Treatment

Sens Motion

CIMON

Clinical Study ID

NCT06438133
CIMON
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Sens Motion
Phase:
Study Start date:
June 10, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Department of Dermatology, Frederiksberg Bispebjerg Hospital

    Bispebjerg, Capital Region
    Denmark

    Active - Recruiting

  • Department of Physiotherapy and Occupational Therapy, Rigshospitalet

    Copenhagen, Capital Region 2100
    Denmark

    Active - Recruiting

  • Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

    Herlev, Capital Region 2730
    Denmark

    Active - Recruiting

  • Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital

    Hvidovre, Capital Region
    Denmark

    Active - Recruiting

  • Department of Oncology, Unit of Lymphedema care, Odense University Hospital

    Odense, Region Of Southern Denmark
    Denmark

    Site Not Available

  • Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg

    Odense, Region of Southern Denmark
    Denmark

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.