ClinicalTrials.gg
Not yet recruitingNCT07732270INFLUX-DUpdated Jul 28, 2026

Evaluation of a Paraclinical Test for the Diagnosis of Arterial Insufficiency in Diabetic Patients With Foot Ulcers

An interventional study of Handheld Doppler in Arterial Insufficiency, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Arterial Insufficiency

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Keywords

  • patients with diabetes
  • Diabetic foot ulcers
03

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 84 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 obtained from the participant and the investigator no later than the day of inclusion and before any study-specific procedure

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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 ,
  • Patient refusing to participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Use of a handheld Doppler to detect blood flow in the great toe(s)

    Procedure: Handheld Doppler

Interventions

  • ProcedureHandheld Doppler

    Use of a handheld Doppler to detect blood flow in the great toe(s)

06

What researchers measure

Primary outcomes

  1. Sensitivity

    Sensitivity of the handheld Doppler compared with the reference standard

    Time frame: 7 days

Secondary outcomes

  1. 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)

    Time frame: 7 days

  2. 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

  3. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol

Time frame: Data will be available immediately following publication

Access criteria: Researchers who provide a methodologically sound proposal will have access to the data

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 24 months is above that.

Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2026
First posted
Jul 28, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2028
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07732270
Lead sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Responsible party
Sponsor
First posted
Jul 28, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Jul 28, 2026

Study contacts

Cécile Duchiron, Project manager
Contact
cecile.duchiron@ght-atlantique17.fr
+33 5 46 68 45 67
Frédérique DUENGLER, Study Director
study director · Groupe Hospitalier de la Rochelle Ré Aunis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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