Clinical Evaluation of an Innovative Non-contact Optical Device for Skin Oxygenation Imaging

Not Applicable

Not yet recruiting

• Conditions: Chronic Wounds; Obliterating Arteriopathy of the Lower Limbs
• Interventions: Device: Oxygen saturation measurement using the IPAM device; Device: Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device

• Registration Number: NCT05187676
• Lead Sponsor: Central Hospital, Nancy, France

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).

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-12-24
• Last Update Submitted: 2021-12-24
• Study Start: 2022-01-03
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2)	Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device	ScO2 values will be measured using IPAM first then TcPO2 values will be measured using Periflux6000. ALways in the same order.
Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2)	Oxygen saturation measurement using the IPAM device	ScO2 values will be measured using IPAM first then TcPO2 values will be measured using Periflux6000. ALways in the same order.

Primary Outcome Measures

Name	Time	Method
Linear regression between the skin oxygen saturation rate (ScO2) values and the Transcutaneous oxygen partial (TcPO2) pressure values	Through study completion, an average of 2 years	The relationship between TcPO2 and ScO2 measurements will be modeled

Secondary Outcome Measures

Name	Time	Method
Risk evaluation: redness will be evaluated on a scale from zero to ten	Through study completion, an average of 2 years	Skin reddening will be evaluated
Rate of clinical decision influenced by the IPAM device	Through study completion, an average of 2 years	Questionnaire about the impact of the IPAM measurement on the clinical decision
Variation coefficient of the IPAM measurement made 3 times in a row on 3 different skin sites	Through study completion, an average of 2 years	Repeatability of the IPAM measurement made 3 times in a row on 3 different skin sites
Ergonomics evaluation in terms of physical and mind efforts	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
Skin surface accessible for measurement in square centimeters	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
Duration of use in seconds	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
Mosaicing software success rate	Through study completion, an average of 2 years	The mosaicing software will be evaluated on a 20s-duration video sequence

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandoeuvre-lès-Nancy, France