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

NCT05187676 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-01-12

No results posted yet for this study

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

Interventions

DEVICE

Oxygen saturation measurement using the IPAM device

Skin oxygen saturation rate will be measured (%) using the non-contact optical device under evaluation called IPAM

DEVICE

Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device

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

Sponsors & Collaborators

  • University of Lorraine

    collaborator OTHER

  • Centre National de la Recherche Scientifique, France

    collaborator OTHER

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187676 on ClinicalTrials.gov