- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187676
Clinical Evaluation of an Innovative Non-contact Optical Device for Skin Oxygenation Imaging (IMOXY)
Study of the Concordance Between Skin Oxygen Saturation Measurements Made by an Innovative Non-contact Optical Imaging Device (IPAM) and the Reference Medical Device (Periflux 6000) in Patients With Skin Vascular Disorders or Chronic Wounds
According to international consensus, information on the level of skin oxygenation is necessary for the diagnostic management of chronic wounds. The measurement of transcutaneous partial oxygen pressure (or TcPO2, according to the acronym) is measurable with a medical device that uses a Clark electrode. Since the medical device in question is expensive and the measurement time-consuming (approximately 45 minutes per patient), the TcPO2 is only rarely accessible (in hospital medicine as in nursing homes) and is therefore not predominant in the clinical decision. The clinical decision is currently mainly based on the result of the ankle blood pressure measurement, which is readily available.
The main objective is to study, from the same skin surfaces (same localization of skin sites and same dimensions of each surface in cm²), in patients with cutaneous vascular disorders or chronic wounds, the relationship between (i) the transcutaneous oxygen saturation values (expressed as a percentage) by the innovative non-contact optical imaging device under study (IPAM, method to be validated) and (ii) the transcutaneous partial oxygen pressure values (TcPO2) (expressed in millimeters of mercury, mmHg) measured by the reference medical device (Périflux6000, gold standard).
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Vandoeuvre-lès-Nancy, France, 54500
- CHRU de Nancy
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Contact:
- Yohann BERNARD
- Phone Number: 0383155273
- Email: y.bernard@chru-nancy.fr
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Principal Investigator:
- Julien AZZI, MD
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Sub-Investigator:
- Athanasios BENETOS, MD-PhD
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Sub-Investigator:
- Nicla SETTEMBRE, MD-PhD
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Sub-Investigator:
- Serguei MALIKOV, MD-PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Major,
- Having signed the informed consent to participate in the clinical study
- Compulsory affiliation to a social security scheme
Presenting at least one of the following two criteria:
- Presence of a PAD at the stage of Chronic Critical Ischemia (CHF) of stage III or IV according to the classification of Leriche and Fontaine,
- Presence of one (or more) chronic wound (s) of the lower limbs of the pressure sore or ulcer type.
Exclusion Criteria:
- Person referred to in Articles L. 1121-5, L1121-6, L. 1121-7 and L1121-8 of the Public Health Code.
- Pregnant woman, parturient or nursing mother
- Minor (non-emancipated)
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- Person of full age unable to express consent
- Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L.3212-1 and L. 3213-1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2)
ScO2 values will be measured using IPAM first then TcPO2 values will be measured using Periflux6000.
ALways in the same order.
|
Skin oxygen saturation rate will be measured (%) using the non-contact optical device under evaluation called IPAM
Skin TcPO2 will be measured (mmHg) using the reference device called PeriFlux6000
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linear regression between the skin oxygen saturation rate (ScO2) values and the Transcutaneous oxygen partial (TcPO2) pressure values
Time Frame: Through study completion, an average of 2 years
|
The relationship between TcPO2 and ScO2 measurements will be modeled
|
Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of clinical decision influenced by the IPAM device
Time Frame: Through study completion, an average of 2 years
|
Questionnaire about the impact of the IPAM measurement on the clinical decision
|
Through study completion, an average of 2 years
|
Variation coefficient of the IPAM measurement made 3 times in a row on 3 different skin sites
Time Frame: Through study completion, an average of 2 years
|
Repeatability of the IPAM measurement made 3 times in a row on 3 different skin sites
|
Through study completion, an average of 2 years
|
Duration of use in seconds
Time Frame: Through study completion, an average of 2 years
|
Comparison of the mean duration time for acquiring one measurement with each of the devices used in the study
|
Through study completion, an average of 2 years
|
Skin surface accessible for measurement in square centimeters
Time Frame: Through study completion, an average of 2 years
|
Comparison of the mean skin surface on which skin oxygen saturation rate and TcPO2 may be measured by each of the two medical devices used fot his study
|
Through study completion, an average of 2 years
|
Ergonomics evaluation in terms of physical and mind efforts
Time Frame: Through study completion, an average of 2 years
|
Using a scale already used for medical devices ergonomics evaluation, the ergonomics of the two devices will be compared
|
Through study completion, an average of 2 years
|
Mosaicing software success rate
Time Frame: Through study completion, an average of 2 years
|
The mosaicing software will be evaluated on a 20s-duration video sequence
|
Through study completion, an average of 2 years
|
Risk evaluation: redness will be evaluated on a scale from zero to ten
Time Frame: Through study completion, an average of 2 years
|
Skin reddening will be evaluated
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-A03140-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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