Clinical trial NCT05187676: Clinical Evaluation of an Innovative Non-contact Optical Device for Skin Oxygenation Imaging
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Wounds
Obliterating Arteriopathy of the Lower Limbs
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
name: Centre National de la Recherche Scientifique, France
First posted: 2022-01-12
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Linear regression between the skin oxygen saturation rate (ScO2) values and the Transcutaneous oxygen partial (TcPO2) pressure values
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Rate of clinical decision influenced by the IPAM device
timeFrame: Through study completion, an average of 2 years
measure: Variation coefficient of the IPAM measurement made 3 times in a row on 3 different skin sites
timeFrame: Through study completion, an average of 2 years
measure: Duration of use in seconds
timeFrame: Through study completion, an average of 2 years
measure: Skin surface accessible for measurement in square centimeters
timeFrame: Through study completion, an average of 2 years
measure: Ergonomics evaluation in terms of physical and mind efforts
timeFrame: Through study completion, an average of 2 years
measure: Mosaicing software success rate
timeFrame: Through study completion, an average of 2 years
measure: Risk evaluation: redness will be evaluated on a scale from zero to ten
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
citation: 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.