Status:
UNKNOWN
Clinical Evaluation of an Innovative Non-contact Optical Device for Skin Oxygenation Imaging
Lead Sponsor:
Central Hospital, Nancy, France
Collaborating Sponsors:
University of Lorraine
Centre National de la Recherche Scientifique, France
Conditions:
Chronic Wounds
Obliterating Arteriopathy of the Lower Limbs
Eligibility:
All Genders
Phase:
NA
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 pressu...
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 devi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05187676
Start Date
January 3 2022
End Date
December 31 2024
Last Update
January 12 2022
Active Locations (1)
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1
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54500