Compression; Vein, Digital Technology, Lymphedema of Leg, Venous Insufficiency
Conditions
Keywords
Compression therapy, Compression bandaging, Chronic edema, Psychometrics
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.
Interventions
OTHERCIMON
The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied.
OTHERSens Motion
The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.
Sponsors
Rigshospitalet, Denmark
Bispebjerg Hospital
Odense University Hospital
Copenhagen University Hospital, Hvidovre
Carsten Bogh Juhl
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edema reduction | 14 days | Assessed by Cimon sensor (in capacitans, pF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edema reduction | 14 days | Assessed by tape measurement (in cm), converted to volume by formula of truncated cone |
| Symptoms related to chronic edema | 14 days | Self-reported pain, tension and heaviness |
| 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 |
Countries
Denmark
Outcome results
None listed