Clinical trial NCT06438133: Digital Supported Compression Bandaging in Patients with Chronic Edema in the Lower Limbs
Official title: Digital Supported Compression Bandaging in Patients with Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Compression; Vein
Venous Insufficiency
Lymphedema of Leg
Digital Technology
Keywords: Compression therapy
Compression bandaging
Chronic edema
Psychometrics
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Bispebjerg Hospital
name: Odense University Hospital
name: Copenhagen University Hospital, Hvidovre
First posted: 2024-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Edema reduction
timeFrame: 14 days
Secondary outcomes:
measure: Edema reduction
timeFrame: 14 days
measure: Edema reduction
timeFrame: 14 days
measure: Edema reduction
timeFrame: 14 days
measure: Symptoms related to chronic edema
timeFrame: 14 days
measure: Physical Activity (PA)
timeFrame: 14 days
measure: Adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Bispebjerg
country: Denmark
facility: Department of Dermatology, Frederiksberg Bispebjerg Hospital
state: Capital Region
city: Copenhagen
country: Denmark
facility: Department of Physiotherapy and Occupational Therapy, Rigshospitalet
state: Capital Region
city: Herlev
country: Denmark
facility: Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
state: Capital Region
city: Hvidovre
country: Denmark
facility: Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital
state: Capital Region
city: Odense
country: Denmark
facility: Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg
state: Region of Southern Denmark
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Carsten Bogh Juhl, Professor
role: STUDY_CHAIR
References: