Arterial InsufficiencyINFLUX-DNCT07732270
Evaluation of a Paraclinical Test for the Diagnosis of Arterial Insufficiency in Diabetic Patients With Foot Ulcers
A study testing Handheld Doppler in people with Arterial Insufficiency, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial summary
The number of people living with diabetes has quadrupled worldwide since 1990, and more than 4.5 million people in France have diabetes. This chronic disease is a major cause of blindness, kidney failure, myocardial infarction, stroke, and lower-limb amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Insufficiency
- What is being tested?
- Handheld Doppler
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥18 years,
- Patient with type 1 or type 2 diabetes,
- Patient with a foot ulcer on one or both feet, regardless of the duration of diabetes (each limb will be considered hemodynamically independent, as the vast majority of arterial lesions in patients with diabetes are located below the inguinal ligament),
- Participant affiliated with or beneficiary of a social security scheme,
- Written informed consent obtained from the participant and the investigator no later than the day of inclusion and before any study-specific procedure
Who cannot join
- Patient with suspected distal thromboembolic disease of the lower limbs,
- Patient with suspected non-atherosclerotic peripheral arterial disease of the lower limbs (Buerger's disease, cannabis-associated arteriopathy, vasculitis, etc.),
- Patient who has previously undergone a revascularization procedure,
- Patient with an acute form of lower limb peripheral arterial occlusive disease,
- Patient with severe sepsis,
- Patient with no remaining great toes,
Show all 10Show fewer
- Person under enhanced protection, including minors, persons deprived of liberty by judicial or administrative decision, and adults under legal protection,
- Pregnant and/or breastfeeding women,
- Patient unable to provide informed consent,
- Patient refusing to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Groupe Hospitalier de La Rochelle Ré Aunis
La Rochelle, France, 17000
Cécile Duchiron, Project Manager, +33 5 46 68 45 67, cecile.duchiron@ght-atlantique17.fr
About this study
Official title: Evaluation of a Paraclinical Test for the Diagnosis of Arterial Insufficiency in Diabetic Patients With Foot Ulcers : INFLUX-D Study
The number of people living with diabetes has quadrupled worldwide since 1990, and more than 4.5 million people in France have diabetes. This chronic disease is a major cause of blindness, kidney failure, myocardial infarction, stroke, and lower-limb amputation. In France, in 2013, the incidence rates of hospitalizations for lower-limb amputation and diabetic foot ulcer among people with diabetes were 252 per 100,000 and 668 per 100,000 individuals with diabetes, respectively.
The management of diabetic foot disease requires a multidisciplinary approach involving general practitioners, diabetologists, dietitians, podiatrists, physiotherapists, and nurses. Nurses working in diabetic foot clinics, wound care centers, and community settings play a key role throughout the continuum of care for people with diabetes. Their responsibilities include prevention, patient education, clinical monitoring, and wound management. When one or more warning signs are identified, nurses promptly alert the physician to ensure early management of infection and timely referral to the appropriate healthcare professional(s).
Read more
One of the major factors contributing to impaired wound healing and ultimately leading to amputation in people with diabetes is arterial insufficiency. This condition is most commonly caused by peripheral artery disease (PAD), which is characterized by progressive atherosclerotic obstruction of the arteries supplying the lower limbs and represents a major cardiovascular disease. In patients with diabetes, PAD differs from atherosclerotic disease in non-diabetic individuals not only because of its higher prevalence but also because of its earlier onset, its frequently asymptomatic course, its predominantly distal distribution involving the infrapopliteal and even below-the-ankle arteries, and its greater severity.
The reference standard for diagnosing arterial insufficiency in patients with diabetes relies on quantitative microcirculatory assessment performed by vascular specialists. These investigations are based on arterial Doppler ultrasound and combine ankle and toe pressure measurements. The ankle-brachial index (ABI), the standard diagnostic test for PAD in non-diabetic patients, has limited reliability in individuals with diabetes because medial arterial calcification frequently renders the arteries incompressible. In contrast, toe pressure measurements can be performed in virtually all patients with diabetes who have intact toes. In selected cases, transcutaneous oxygen pressure (TcPO₂) measurement may also provide valuable additional information.
The availability of these investigations depends on access to vascular specialists, as a comprehensive vascular assessment may take up to two hours and varies according to local clinical practice and available resources.
Portable handheld vascular Doppler devices equipped with an 8-MHz probe are now available at an affordable cost and can be readily used in diabetic foot clinics, wound care centers, and community-based practices.
We hypothesize that this medical device, which assesses the overall hemodynamic status of the lower limb, could serve as a first-line screening tool for patients with diabetes presenting with a foot wound. This rapid assessment could facilitate early identification of patients requiring further vascular investigations by a vascular specialist when no arterial blood flow is detected.
- Conditions
- Arterial Insufficiency
- Being tested
- Handheld Doppler
- Keywords
- patients with diabetes, Diabetic foot ulcers
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld DopplerProcedure or surgery
Use of a handheld Doppler to detect blood flow in the great toe(s)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Use of a handheld Doppler to detect blood flow in the great toe(s) Receives: Procedure: Handheld Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of the handheld Doppler compared with the reference standard
Measured: 7 days
Secondary outcomes (3)
Specificity
Specificity, defined as the proportion of diabetic feet in which blood flow in the great toe was detected by the foot clinic nurses and for which no arterial insufficiency was confirmed by the vascular physician's assessment (true negatives, TN), among diabetic feet for which the reference standard (microcirculatory tests) performed by the vascular physician showed no arterial insufficiency (TN + false positives, FP)
Measured: 7 days
Number of limbs with a positive or negative Doppler blood flow test at the great toe, according to the nurse's assessment at the beginning and at the end of the nursing assessment.
Measured: 1 day
Number of limbs with a positive or negative Doppler blood flow test at the great toe, as assessed independently by two foot clinic nurses. The two nurses will be blinded to each other's assessment results
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial InsufficiencyStudies of the same condition, open and under way.
- 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique DUENGLER, Study Director, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732270
- Sponsor's protocol ID
- P02039
- Other IDs
- 2026-A01497-44
- Acronym
- INFLUX-D
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available with publication. A Digital Object Identifier will be used and Data will be available at www.recherche.data.gouv.fr
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Paraclinical Test for the Diagnosis of Arterial Insufficiency in Diabetic Patients With Foot Ulcers : INFLUX-D Study
- ClinicalTrials.gov ID
- NCT07732270
- Acronym / sponsor ID
- INFLUX-D / P02039
- Conditions
- Arterial Insufficiency
- Keywords
- patients with diabetes, Diabetic foot ulcers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 Jul 2026 (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.
The number of people living with diabetes has quadrupled worldwide since 1990, and more than 4.5 million people in France have diabetes. This chronic disease is a major cause of blindness, kidney failure, myocardial infarction, stroke, and lower-limb amputation. In France, in 2013, the incidence rates of hospitalizations for lower-limb amputation and diabetic foot ulcer among people with diabetes were 252 per 100,000 and 668 per 100,000 individuals with diabetes, respectively.
The management of diabetic foot disease requires a multidisciplinary approach involving general practitioners, diabetologists, dietitians, podiatrists, physiotherapists, and nurses. Nurses working in diabetic foot clinics, wound care centers, and community settings play a key role throughout the continuum of care for people with diabetes. Their responsibilities include prevention, patient education, clinical monitoring, and wound management. When one or more warning signs are identified, nurses promptly alert the physician to ensure early management of infection and timely referral to the appropriate healthcare professional(s).
One of the major factors contributing to impaired wound healing and ultimately leading to amputation in people with diabetes is arterial insufficiency. This condition is most commonly caused by peripheral artery disease (PAD), which is characterized by progressive atherosclerotic obstruction of the arteries supplying the lower limbs and represents a major cardiovascular disease. In patients with diabetes, PAD differs from atherosclerotic disease in non-diabetic individuals not only because of its higher prevalence but also because of its earlier onset, its frequently asymptomatic course, its predominantly distal distribution involving the infrapopliteal and even below-the-ankle arteries, and its greater severity.
The reference standard for diagnosing arterial insufficiency in patients with diabetes relies on quantitative microcirculatory assessment performed by vascular specialists. These investigations are based on arterial Doppler ultrasound and combine ankle and toe pressure measurements. The ankle-brachial index (ABI), the standard diagnostic test for PAD in non-diabetic patients, has limited reliability in individuals with diabetes because medial arterial calcification frequently renders the arteries incompressible. In contrast, toe pressure measurements can be performed in virtually all patients with diabetes who have intact toes. In selected cases, transcutaneous oxygen pressure (TcPO₂) measurement may also provide valuable additional information.
The availability of these investigations depends on access to vascular specialists, as a comprehensive vascular assessment may take up to two hours and varies according to local clinical practice and available resources.
Portable handheld vascular Doppler devices equipped with an 8-MHz probe are now available at an affordable cost and can be readily used in diabetic foot clinics, wound care centers, and community-based practices.
We hypothesize that this medical device, which assesses the overall hemodynamic status of the lower limb, could serve as a first-line screening tool for patients with diabetes presenting with a foot wound. This rapid assessment could facilitate early identification of patients requiring further vascular investigations by a vascular specialist when no arterial blood flow is detected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Handheld DopplerUse of a handheld Doppler to detect blood flow in the great toe(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged ≥18 years,
- Patient with type 1 or type 2 diabetes,
- Patient with a foot ulcer on one or both feet, regardless of the duration of diabetes (each limb will be considered hemodynamically independent, as the vast majority of arterial lesions in patients with diabetes are located below the inguinal ligament),
- Participant affiliated with or beneficiary of a social security scheme,
- Written informed consent obtained from the participant and the investigator no later than the day of inclusion and before any study-specific procedure
Key exclusion criteria (10 listed)
- Patient with suspected distal thromboembolic disease of the lower limbs,
- Patient with suspected non-atherosclerotic peripheral arterial disease of the lower limbs (Buerger's disease, cannabis-associated arteriopathy, vasculitis, etc.),
- Patient who has previously undergone a revascularization procedure,
- Patient with an acute form of lower limb peripheral arterial occlusive disease,
- Patient with severe sepsis,
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 |
|---|---|---|
| Handheld DopplerUse of a handheld Doppler to detect blood flow in the great toe(s) | Procedure or surgery | Experimental group |
Primary outcome
Sensitivity
Time frame: 7 days
Sensitivity of the handheld Doppler compared with the reference standard
3 secondary outcomes
Specificity
Time frame: 7 days
Number of limbs with a positive or negative Doppler blood flow test at the great toe, according to the nurse's assessment at the beginning and at the end of the nursing assessment.
Time frame: 1 day
Number of limbs with a positive or negative Doppler blood flow test at the great toe, as assessed independently by two foot clinic nurses. The two nurses will be blinded to each other's assessment results
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Data will be made available with publication. A Digital Object Identifier will be used and Data will be available at www.recherche.data.gouv.fr
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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.
Frédérique DUENGLER, Study Director study director
Groupe Hospitalier de la Rochelle Ré Aunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld Doppler in people with Arterial Insufficiency, run by Groupe Hospitalier de la Rochelle Ré Aunis 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécile Duchiron, Project manager (+33 5 46 68 45 67, cecile.duchiron@ght-atlantique17.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.