Using a digital sensor to improve compression bandaging for chronic leg swelling
Digital Supported Compression Bandaging in Patients with Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor
This study is testing a new digital sensor to see if it can help improve compression bandaging for people with chronic leg swelling by monitoring how well the treatment is working over two weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 5 sites (Bispebjerg, Capital Region and 4 other locations) |
| Trial ID | NCT06438133 on ClinicalTrials.gov |
What this trial studies
This study involves patients with chronic edema in the lower limbs who are referred for compression bandaging. Participants will have a novel sensor, CIMON, applied to their leg to monitor the effectiveness of the compression treatment over a 14-day period. The sensor measures changes in capacitance as it stretches around the calf, and the data is transmitted via Bluetooth to healthcare professionals for real-time monitoring. The study aims to validate the sensor's psychometric properties and explore the relationship between edema reduction and physical activity during treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic edema of the lower limb who are referred for compression bandaging and have a calf circumference between 35-75 cm.
Not a fit: Patients with wounds, acute deep venous thrombosis, untreated cellulitis, or severe heart or kidney failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of compression therapy for patients with chronic edema, leading to better management of their condition.
How similar studies have performed: While the use of digital technology in monitoring compression therapy is emerging, this specific approach with the CIMON sensor is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bispebjerg, Capital Region and 4 other locations
- Department of Dermatology, Frederiksberg Bispebjerg Hospital — Bispebjerg, Capital Region, Denmark (Recruiting)
- Department of Physiotherapy and Occupational Therapy, Rigshospitalet — Copenhagen, Capital Region, Denmark (Recruiting)
- Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital — Herlev, Capital Region, Denmark (Recruiting)
- Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital — Hvidovre, Capital Region, Denmark (Recruiting)
- Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg — Odense, Region of Southern Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Merete Celano Wittenkamp, MPH
- Email: merete.celano.wittenkamp@regionh.dk
- Phone: +004593911784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.