NCT03518190

Brief Summary

The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

April 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

April 25, 2018

Last Update Submit

April 27, 2022

Conditions

Pressure Ulcer Not Visible

Outcome Measures

Primary Outcomes (2)

  • Early detection of pressure induced tissue damage

    Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury

    Ten minutes

  • Pressure injury probability

    Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days

    Ten minutes

Study Arms (1)

Suspected pressure injury

EXPERIMENTAL

Patients evaluated with high-risk for pressure injury

Device: Infrared spectroscopy (ODP)

Interventions

Infrared spectroscopy (ODP)DEVICE

Infrared spectroscopy device will be used to detect non-visible pressure injuries

Suspected pressure injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stage 1 pressure injury
  • Patients with high risk of developing pressure injury

You may not qualify if:

  • Patients with stage 2 pressure injury or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam healrh care campus

Haifa, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Plastic Surgery Department

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 8, 2018

Study Start

July 30, 2018

Primary Completion

May 12, 2021

Study Completion

May 12, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)