## Protocol Section
### Identification Module
**NCT ID:** NCT06438133

**Acronym:** CIMON

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CIMON
#### Organization
**Class:** OTHER
**Full Name:** Herlev and Gentofte Hospital
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Rigshospitalet, Denmark

**Class:** OTHER

**Name:** Hvidovre University Hospital

**Class:** OTHER

**Name:** Bispebjerg Hospital

**Class:** OTHER

**Name:** Odense University Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Carsten Bogh Juhl

#### Responsible Party

**Investigator Affiliation:** Herlev and Gentofte Hospital

**Investigator Full Name:** Carsten Bogh Juhl

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Compression; Vein

- Venous Insufficiency

- Lymphedema of Leg

- Digital Technology

**Keywords:**

- Compression therapy

- Compression bandaging

- Chronic edema

- Psychometrics

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.

**Intervention Names:**

- Other: CIMON

- Other: Sens Motion

**Label:** Patients with chronic edema of the lower limbs

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients with chronic edema of the lower limbs

**Description:** The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied.

**Name:** CIMON

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Patients with chronic edema of the lower limbs

**Description:** The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.

**Name:** Sens Motion

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Assessed by Cimon sensor, tape measurement, tissue dielectic constant, perometry and dual xray energy absorptiometry (DXA)

**Measure:** Edema reduction

**Time Frame:** 14 days

#### Secondary Outcomes

**Description:** Self-reported pain, tension and heaviness

**Measure:** Symptoms related to chronic edema

**Time Frame:** 14 days

**Description:** Assessed by Sens Motion sensor

**Measure:** Physical Activity

**Time Frame:** 14 days

**Description:** Any adverse events related to compression bandaging and the application of sensors

**Measure:** Adverse events

**Time Frame:** 14 days

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** merete.celano.wittenkamp@regionh.dk

**Name:** Merete Celano Wittenkamp, MPH

**Phone:** +93911784

**Role:** CONTACT

**Contact 2:**

**Email:** carsten.bogh.juhl@regionh.dk

**Name:** Carsten Bogh Juhl, Professor

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bispebjerg

**Contacts:**

***Contact 1:***

- **Name:** Mette L Joergensen, RN

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Department of Dermatology, Frederiksberg Bispebjerg Hospital

**State:** Capital Region

**Location 2:**

**City:** Copenhagen

**Contacts:**

***Contact 1:***

- **Name:** Jan Christensen, Phd

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Department of Physiotherapy and Occupational Therapy, Rigshospitalet

**State:** Capital Region

**Zip:** 2100

**Location 3:**

**City:** Herlev

**Contacts:**

***Contact 1:***

- **Email:** merete.celano.wittenkamp@regionh.dk

- **Name:** Merete C Wittenkamp, MPH

- **Phone:** +4593911784

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

**State:** Capital Region

**Zip:** 2730

**Location 4:**

**City:** Hvidovre

**Contacts:**

***Contact 1:***

- **Name:** Kira Marie Milandt Skibdal, Msc

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital

**State:** Capital Region

**Location 5:**

**City:** Odense

**Contacts:**

***Contact 1:***

- **Name:** Marianne Holt, Msc

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Department of Oncology, Unit of Lymphedema care, Odense University Hospital

**State:** Region Of Southern Denmark

#### Overall Officials

**Official 1:**

**Affiliation:** Herlev and Gentofte Hospital

**Name:** Carsten Bogh Juhl, Professor

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17435

- Name: Venous Insufficiency

- Relevance: HIGH

- As Found: Venous Insufficiency

- ID: M11206

- Name: Lymphedema

- Relevance: HIGH

- As Found: Lymphedema

- ID: M7657

- Name: Edema

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014689

- Term: Venous Insufficiency

- ID: D000008209

- Term: Lymphedema

### Misc Info Module

- Version Holder: 2024-05-31
