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).
The InnovaTICs Dépendance project, funded by the Grand Region Is, aims to develop a medical device meeting the need to measure quickly and non-invasively the skin oxygen saturation. To do this, a device medical was developed by CRAN (Joint Research Unit of the University of Lorraine and CNRS); its industrial transfer was entrusted to the company SD Innovation to produce the VRPC device for "video-reconstruction of chronic wounds". The VRPC medical device makes it possible to measure skin oxygen saturation by an optical (atraumatic) and non-contact (non-invasive) method, more quickly than the current method proposes. The capacity of the VRPC device to measure in vivo variations in skin oxygen saturation was confirmed by carrying out measurements on healthy volunteers. The measured values made it possible to show that the VRPC device was able to detect the difference in skin oxygen saturation between the skin covering a "healthy" finger and the skin covering the same finger but after a tourniquet had been placed at the base of the first phalanx of the finger (data not published).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
70
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
CHRU de Nancy
Vandœuvre-lès-Nancy, France
Linear regression between the skin oxygen saturation rate (ScO2) values and the Transcutaneous oxygen partial (TcPO2) pressure values
The relationship between TcPO2 and ScO2 measurements will be modeled
Time frame: Through study completion, an average of 2 years
Rate of clinical decision influenced by the IPAM device
Questionnaire about the impact of the IPAM measurement on the clinical decision
Time frame: 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
Repeatability 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
Duration of use in seconds
Comparison of the mean duration time for acquiring one measurement with each of the devices used in the study
Time frame: Through study completion, an average of 2 years
Skin surface accessible for measurement in square centimeters
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
Time frame: Through study completion, an average of 2 years
Ergonomics evaluation in terms of physical and mind efforts
Using a scale already used for medical devices ergonomics evaluation, the ergonomics of the two devices will be compared
Time frame: Through study completion, an average of 2 years
Mosaicing software success rate
The mosaicing software will be evaluated on a 20s-duration video sequence
Time frame: Through study completion, an average of 2 years
Risk evaluation: redness will be evaluated on a scale from zero to ten
Skin reddening will be evaluated
Time frame: Through study completion, an average of 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.