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

NCT05187676 | Unknown

• 1 other identifier: 2020-A03140-39
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Wounds; Obliterating Arteriopathy of the Lower Limbs

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Rate of clinical decision influenced by the IPAM device

  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

  Through study completion, an average of 2 years

• Duration of use in seconds

  Through study completion, an average of 2 years

• Skin surface accessible for measurement in square centimeters

  Through study completion, an average of 2 years

• Ergonomics evaluation in terms of physical and mind efforts

  Through study completion, an average of 2 years

Study Arms (1)

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.

Device: Oxygen saturation measurement using the IPAM device; Device: Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device

Interventions

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

Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2)

Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device DEVICE

Skin TcPO2 will be measured (mmHg) using the reference device called PeriFlux6000

Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• 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.

  PMID: 31159978 BACKGROUND

Central Study Contacts

Yohann BERNARD

CONTACT

0383155272; y.bernard@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: January 12, 2022
• Study Start: January 3, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 12, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)