Compression; VeinCIMONNCT06438133
Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs
An observational study of Compression; Vein and Venous Insufficiency, run by Carsten Bogh Juhl at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compression; Vein, Venous Insufficiency, Lymphedema of Leg
- What is being tested?
- CIMON and Sens Motion
- How many people
- 52 participants
- Where
- 5 sitesDenmark
- Study dates
- 10 Jun 2024to 18 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.
Who may be able to join
- Chronic edema of the lower limb
- Referred to compression bandaging
- Circumference of widest point of the lower leg between 35-75 cm
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Department of Dermatology, Frederiksberg Bispebjerg Hospital
Bispebjerg, Capital Region
Department of Physiotherapy and Occupational Therapy, Rigshospitalet
Copenhagen, Capital Region, 2100
Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital
Herlev, Capital Region, 2730
Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital
Hvidovre, Capital Region
Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg
Odense, Region Syddanmark
About this study
Official title: Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor
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.
Read the 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.
- Being tested
- CIMON, Sens Motion
- Keywords
- Compression therapy, Compression bandaging, Chronic edema, Psychometrics
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMONOther
The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied.
Sens MotionOther
The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic edema of the lower limbs | Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting. Receives: Other: CIMON; Other: Sens Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema reduction
Assessed by Cimon sensor (in capacitans, pF)
Measured: 14 days
Secondary outcomes (6)
Edema reduction
Assessed by tape measurement (in cm), converted to volume by formula of truncated cone
Measured: 14 days
Edema reduction
Assessed by perometry (in ml)
Measured: 14 days
Edema reduction
Assessed by Dual energy X-ray Absorptiometry (in kg)
Measured: 14 days
Symptoms related to chronic edema
Self-reported pain, tension and heaviness
Measured: 14 days
Physical Activity (PA)
Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes)
Measured: 14 days
Adverse events
Any adverse events related to compression bandaging and the application of sensors
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start10 Jun 2024
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compression; VeinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carsten Bogh Juhl
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Odense University Hospital, Copenhagen University Hospital, Hvidovre
- Responsible party
- Sponsor-investigator, Carsten Bogh Juhl, Herlev and Gentofte Hospital
- Investigators
- Carsten Bogh Juhl, Professor, Study chair, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438133
- Sponsor's protocol ID
- CIMON
- Acronym
- CIMON
- Status last verified
- Dec 2025
- First submitted
- 27 May 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor
- ClinicalTrials.gov ID
- NCT06438133
- Acronym / sponsor ID
- CIMON / CIMON
- Keywords
- Compression therapy, Compression bandaging, Chronic edema, Psychometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Carsten Bogh JuhlUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Odense University Hospital, Copenhagen University Hospital, Hvidovre
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic edema of the lower limbs | – | Other: CIMON, Other: Sens MotionPatients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.
Key inclusion criteria (3 listed)
- Chronic edema of the lower limb
- Referred to compression bandaging
- Circumference of widest point of the lower leg between 35-75 cm
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIMONThe sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied. | Other | Patients with chronic edema of the lower limbs |
| Sens MotionThe sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps. | Other | Patients with chronic edema of the lower limbs |
Primary outcome
Edema reduction
Time frame: 14 days
Assessed by Cimon sensor (in capacitans, pF)
6 secondary outcomes
Edema reduction
Time frame: 14 days
Edema reduction
Time frame: 14 days
Edema reduction
Time frame: 14 days
Symptoms related to chronic edema
Time frame: 14 days
Physical Activity (PA)
Time frame: 14 days
Adverse events
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Bogh Juhl, Professor study chair
Herlev and Gentofte Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compression; Vein and Venous Insufficiency, run by Carsten Bogh Juhl at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema reduction (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.