NCT06438133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

May 27, 2024

Last Update Submit

December 19, 2025

Conditions

Compression; VeinVenous InsufficiencyLymphedema of LegDigital Technology

Keywords

Compression therapyCompression bandagingChronic edemaPsychometrics

Outcome Measures

Primary Outcomes (1)

  • Edema reduction

    Assessed by Cimon sensor (in capacitans, pF)

    14 days

Secondary Outcomes (6)

  • Edema reduction

    14 days

  • Edema reduction

    14 days

  • Edema reduction

    14 days

  • Symptoms related to chronic edema

    14 days

  • Physical Activity (PA)

    14 days

  • +1 more secondary outcomes

Study Arms (1)

Patients with chronic edema of the lower limbs

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

Other: CIMONOther: Sens Motion

Interventions

CIMONOTHER

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

Patients with chronic edema of the lower limbs
Sens MotionOTHER

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

Patients with chronic edema of the lower limbs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Chronic edema of the lower limb
  • Referred to compression bandaging
  • Circumference of widest point of the lower leg between 35-75 cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Dermatology, Frederiksberg Bispebjerg Hospital

Bispebjerg, Capital Region, Denmark

Location

Department of Physiotherapy and Occupational Therapy, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

Herlev, Capital Region, 2730, Denmark

Location

Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital

Hvidovre, Capital Region, Denmark

Location

Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg

Odense, Region Syddanmark, Denmark

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Carsten Bogh Juhl, Professor

    Herlev and Gentofte Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

June 10, 2024

Primary Completion

December 18, 2025

Study Completion

December 18, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)