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CompletedNCT04402398IMITOUpdated May 26, 2020

Psychometric Properties of a Mobile Application

An observational study in Spinal Cord Injuries, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-26.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
59
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Spinal Cord Injuries

Keywords

  • Pressure ulcer
  • validity of measures
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 59 is close to the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult Patients, providing consent for study, with complete or incomplete spinal cord injury, with pressure ulcers requiring hospital follow-up (lesion stade II to IV), followed at Centre Mutualiste Propara, rehabilitation centre, Montpellier, France

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

Exclusion criteria:

  • refusal to participate
  • local infection
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
59 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

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

    Time frame: immediately upon first assessment of patients

Secondary outcomes

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

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

    Time frame: immediately upon first assessment of patients

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

    inter-rater and intra-rater validity of imitoMeasure

    Time frame: immediately upon first assessment of patients

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

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

    Time frame: immediately upon first assessment of patients

07

Study locations

1 site
  • Uh Montpellier
    Montpellier, 34295, France
08

References and documents

Publications

  • Do Khac A, Jourdan C, Fazilleau S, Palayer C, Laffont I, Dupeyron A, Verdun S, Gelis A. mHealth App for Pressure Ulcer Wound Assessment in Patients With Spinal Cord Injury: Clinical Validation Study. JMIR Mhealth Uhealth. 2021 Feb 23;9(2):e26443. doi: 10.2196/26443. PubMed 33620327 ↗

Individual participant data

Plan to share: Undecided — NC

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04402398
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
May 26, 2020
Start date
May 1, 2019
Primary completion
Feb 1, 2020
Completion
Feb 20, 2020
Last update
May 26, 2020

Study contacts

Isabelle LAFFONT
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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