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| Name | Class |
|---|---|
| University of Lorraine | OTHER |
| Centre National de la Recherche Scientifique, France | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2) | Experimental | ScO2 values will be measured using IPAM first then TcPO2 values will be measured using Periflux6000. ALways in the same order. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen saturation measurement using the IPAM device | Device | Skin oxygen saturation rate will be measured (%) using the non-contact optical device under evaluation called IPAM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical decision influenced by the IPAM device | 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 |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yohann BERNARD | Contact | 0383155272 | y.bernard@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Vandœuvre-lès-Nancy | 54500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31159978 | Background | Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH; GVG Writing Group. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019 Jun;69(6S):3S-125S.e40. doi: 10.1016/j.jvs.2019.02.016. Epub 2019 May 28. |
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| Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device | Device | Skin TcPO2 will be measured (mmHg) using the reference device called PeriFlux6000 |
|
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 | 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 | 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 | 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 | 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 | Skin reddening will be evaluated | Through study completion, an average of 2 years |