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
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.
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 →Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of a handheld Doppler to detect blood flow in the great toe(s)
Procedure: Handheld Doppler
Use of a handheld Doppler to detect blood flow in the great toe(s)
Sensitivity
Sensitivity of the handheld Doppler compared with the reference standard
Time frame: 7 days
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
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
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.
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.
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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Groupe Hospitalier de la Rochelle Ré Aunis