Chronic WoundsIMOXYNCT05187676
Clinical Evaluation of an Innovative Non-contact Optical Device for Skin Oxygenation Imaging
A study testing Oxygen saturation measurement using the IPAM device and Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device in people with Chronic Wounds and Obliterating Arteriopathy of the Lower Limbs, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Wounds, Obliterating Arteriopathy of the Lower Limbs
- What is being tested?
- Oxygen saturation measurement using the IPAM device and Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Nancy
Vandœuvre-lès-Nancy, 54500
Yohann BERNARD, 0383155273, y.bernard@chru-nancy.fr
Julien AZZI, MD
About this study
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
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).
Read the 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).
- Being tested
- Oxygen saturation measurement using the IPAM device, Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen saturation measurement using the IPAM deviceDevice
Skin oxygen saturation rate will be measured (%) using the non-contact optical device under evaluation called IPAM
Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 deviceDevice
Skin TcPO2 will be measured (mmHg) using the reference device called PeriFlux6000
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oxygen saturation measurement using the IPAM device; Device: Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 years
Secondary outcomes (7)
Rate of clinical decision influenced by the IPAM device
Questionnaire about the impact of the IPAM measurement on the clinical decision
Measured: 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
Repeatability of the IPAM measurement made 3 times in a row on 3 different skin sites
Measured: Through study completion, an average of 2 years
Duration of use in seconds
Comparison of the mean duration time for acquiring one measurement with each of the devices used in the study
Measured: Through study completion, an average of 2 years
Skin surface accessible for measurement in square centimeters
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
Measured: Through study completion, an average of 2 years
Ergonomics evaluation in terms of physical and mind efforts
Using a scale already used for medical devices ergonomics evaluation, the ergonomics of the two devices will be compared
Measured: Through study completion, an average of 2 years
Mosaicing software success rate
The mosaicing software will be evaluated on a 20s-duration video sequence
Measured: Through study completion, an average of 2 years
Risk evaluation: redness will be evaluated on a scale from zero to ten
Skin reddening will be evaluated
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start3 Jan 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine, Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187676
- Sponsor's protocol ID
- 2020-A03140-39
- Acronym
- IMOXY
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31159978
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05187676
- Acronym / sponsor ID
- IMOXY / 2020-A03140-39
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine, Centre National de la Recherche Scientifique, France
- Study start
- 3 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2) | Experimental | Device: Oxygen saturation measurement using the IPAM device, Device: Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 deviceScO2 values will be measured using IPAM first then TcPO2 values will be measured using Periflux6000. ALways in the same order. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen saturation measurement using the IPAM deviceSkin oxygen saturation rate will be measured (%) using the non-contact optical device under evaluation called IPAM | Device | Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2) |
| Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 deviceSkin TcPO2 will be measured (mmHg) using the reference device called PeriFlux6000 | Device | Oxygen cutaneous saturation rate (ScO2) then transcutaneous oxygen partial pressure (TcPO2) |
Primary outcome
Linear regression between the skin oxygen saturation rate (ScO2) values and the Transcutaneous oxygen partial (TcPO2) pressure values
Time frame: Through study completion, an average of 2 years
The relationship between TcPO2 and ScO2 measurements will be modeled
7 secondary outcomes
Rate of clinical decision influenced by the IPAM device
Time frame: 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
Time frame: Through study completion, an average of 2 years
Duration of use in seconds
Time frame: Through study completion, an average of 2 years
Skin surface accessible for measurement in square centimeters
Time frame: Through study completion, an average of 2 years
Ergonomics evaluation in terms of physical and mind efforts
Time frame: Through study completion, an average of 2 years
Mosaicing software success rate
Time frame: Through study completion, an average of 2 years
Risk evaluation: redness will be evaluated on a scale from zero to ten
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Background: PubMed 31159978Conte 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen saturation measurement using the IPAM device and Transcutaneous oxygen partial pressure (TcPO2) using the PeriFlux6000 device in people with Chronic Wounds and Obliterating Arteriopathy of the Lower Limbs, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yohann BERNARD (0383155272, y.bernard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear regression between the skin oxygen saturation rate (ScO2) values and the Transcutaneous oxygen partial (TcPO2) pressure values (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05187676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.