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OpenTrials
Completed

NCT Number: NCT04402398

Psychometric Properties of a Mobile Application

Current methods to assess superficial size and area of pressure ulcers are either time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or necessitating to touch the patient's skin (using commun rulers).

A free smartphone application (for IOS or Android) has recently been developed to measures skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A photograph is taken with the smartphone, the limits of the lesion is then drawn with the health carers' finger on the phone's screen. The application computes the length, width and surface of the ulcer.

This technique has not yet been validated, although it has been used to measure various types of skin lesions.

The objective of this study is to validate this measurement technique on a sample of pressure ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by comparison to the currently most frequently used techniques (Transparency Tracings and ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.

imitoMeasure is a new smartphone application to measure wounds size. The present study assesses validity of the measure against common measures (ruler-based and transparency tracings), and the inter- and intra-rater reliability.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • complete or incomplete spinal cord injury, all delays or aetiologies
  • presence of one or more pressure ulcers stade II to IV
  • adults

Exclusion criteria

  • refusal to participate
  • local infection

Treatment and study plan

Primary outcomes

  1. Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure

    Time frame: immediately upon first assessment of patients

    Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure

Secondary outcomes

  1. Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure

    Time frame: immediately upon first assessment of patients

    Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure

  2. inter-rater and intra-rater validity of imitoMeasure

    Time frame: immediately upon first assessment of patients

    inter-rater and intra-rater validity of imitoMeasure

  3. Correlation of imitoMeasure of length and width of ulcers to ruler-based measures

    Time frame: immediately upon first assessment of patients

    Correlation of imitoMeasure of length and width of ulcers to ruler-based measures

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)

Acronym: IMITO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 26, 2020
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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