Venous Insufficiency Clinical Trial
— CIMONOfficial title:
Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor
NCT number | NCT06438133 |
Other study ID # | CIMON |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | December 2025 |
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Dermatology, Frederiksberg Bispebjerg Hospital | Bispebjerg | Capital Region |
Denmark | Department of Physiotherapy and Occupational Therapy, Rigshospitalet | Copenhagen | Capital Region |
Denmark | Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital | Herlev | Capital Region |
Denmark | Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital | Hvidovre | Capital Region |
Denmark | Department of Oncology, Unit of Lymphedema care, Odense University Hospital | Odense | Region Of Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Carsten Bogh Juhl | Bispebjerg Hospital, Hvidovre University Hospital, Odense University Hospital, Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Edema reduction | Assessed by Cimon sensor (in capacitans, pF) | 14 days | |
Secondary | Edema reduction | Assessed by tape measurement (in cm), converted to volume by formula of truncated cone | 14 days | |
Secondary | Edema reduction | Assessed by perometry (in ml) | 14 days | |
Secondary | Edema reduction | Assessed by Dual energy X-ray Absorptiometry (in kg) | 14 days | |
Secondary | Symptoms related to chronic edema | Self-reported pain, tension and heaviness | 14 days | |
Secondary | Physical Activity (PA) | Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes) | 14 days | |
Secondary | Adverse events | Any adverse events related to compression bandaging and the application of sensors | 14 days |
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