Atherosclerotic Peripheral Arterial DiseaseGWADAOMINCT07233356
Novel Risk Factors and Localization of Peripheral Arterial Disease
An observational study of Atherosclerotic Peripheral Arterial Disease and Hemoglobin A1c Protein, Human, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
Background: .Atherosclerotic peripheral arterial disease (PAD) is associated with a high risk of mortality, coronary events and stroke. The distal localization is frequently associated with amputation. Patients from African origin have a higher prevalence of PAD independently of age and other risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Peripheral Arterial Disease, Hemoglobin A1c Protein, Human, Guadeloupe
- How many people
- 123 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 4 Apr 2019to 22 Apr 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a Doppler ultra sound for known PAD or newly diagnosed PAD at hospital or at vascular doctor's offices will be proposed to participate in the study. PAD will be diagnosed if systolic pressure index< 0.9 or toe systolic pressure < 85 mmHg or tissue oxygen saturation <65 mmHg or if there is a stenosis > 50 % or an occlusion.. If the culprit lesion is infra popliteal they will be included in group 1. If the culprit lesion is supra or popliteal they will be included in group 2.
Who may be able to join
- men or women aged more than 18 years old
- with PAD diagnosed with systolic pressure index (SPI) <0.9 or toe systolic pressure <85 mmHg or tissue oxygen saturation < 65 mmHg or with stenosis >50 % or occlusion of one or more arteries
- Patients with or without diabetes
- with stenosis >50 % or occlusion of one or more arteries, infra popliteal, supra or popliteal
- wishing to take part in the study
- having signed the informed consent
- Patients affiliated or beneficiary of a social security scheme
Who cannot join
- Patients aged less than 18 years old
- Patients who do not wish to participate in the study
- Patients with PAD with localization infra popliteal and supra popliteal or popliteal (stenosis > 50 % or occlusion of an artery at supra popliteal or popliteal level AND infra popliteal level)
- Patients with an history of revascularization at supra popliteal, popliteal or infra popliteal level AND stenosis on a different territory.
- Patients with medial calcific sclerosis without PAD
- PAD from non-atherosclerotic origin
- Patient non-affiliated to the social security scheme
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
Centre Hospitalier Universitaire de la Guadeloupe
Pointe-à-Pitre, Guadeloupe, 97159
About this study
Background: .Atherosclerotic peripheral arterial disease (PAD) is associated with a high risk of mortality, coronary events and stroke. The distal localization is frequently associated with amputation. Patients from African origin have a higher prevalence of PAD independently of age and other risk factors. In Guadeloupe, French West Indies, infra popliteal localization is more frequent than in France continental associated with different risk factors (88% of hypertension, 2/3 of diabetes).
Purpose: Traditional risk factors of PAD are smoking diabetes, hypertension, high lipid levels, age, and family history of cardiovascular events. The role of novel risk factors in PAD has recently been shown: fibrinogen, CRP-us, homocysteine, interleukin 6, the neutrophil-to-lymphocyte ratio, the urinary albumin-to-creatinine ratio, alkaline phosphatases, insulin resistance, uric acid, D dimer, vitamin D deficiency, HBA1C. Thus the purpose of the research is to study the role of novel risk factors in the occurrence of infrapopliteal PAD. The primary criterion is the HBA1C.
Read the detailed description
In Guadeloupe, French West Indies, a high prevalence of distal (infra popliteal) PAD has been observed compared to France continental, the risk factors associated with the distal localization are diabetes and hypertension. Novel risk factors in PAD have been highlighted such as fibrinogen, CRP-us, homocysteine, interleukin 6, the neutrophil-to-lymphocyte ratio, the urinary albumin-to-creatinine ratio, alkaline phosphatases, insulin resistance, uric acid, D dimer, vitamin D deficiency. HBA1 C is also an independent novel risk factor of PAD in diabetic and non-diabetic patients. It seems that risk factors are different according to the localization of the disease. Thus the aim of the research is to study the role of novel risk factors in the localization of PAD. The primary outcome is the HBA1C. The secondary outcome is the role of other risk factors in the localization of PAD. This is a cross sectional study. Patients with PAD diagnosed with systolic pressure index< 0.9 or toe systolic pressure < 85 mmHg or tissue oxygen saturation <65 mmHg or with stenosis > 50 % or occlusion will be proposed to participate in the study. If the culprit lesion is infra popliteal they will be included in group 1. If the culprit lesion is supra or popliteal they will be included in group 2. Patients will be informed of the study and the written informed consent will be obtained. Clinical and para clinical date will be taken on the same date (V0). Then the patient will have to go to the Pointe à Pitre hospital within one month for a second visit (V1) where blood and urinary samples will be taken. Interleukin 6 and insulin in non-diabetic and blood collection will specially be taken for the study.
- Keywords
- Hemoglobin A1c, Atherosclerotic peripheral arterial disease, distal localization,, novel risk factors,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | culprit lesion is infra popliteal | |
| group 2 | culprit lesion is supra or popliteal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
pourcentage
Measured: between day 0 to month 3
Secondary outcomes (10)
novel risk factors fibrinogen
g/L
Measured: between day 0 and month 3
novel risk factors homocysteine
umol/L
Measured: between day 0 an month 3
novel risk factors interleukin 6,
pg/mL
Measured: between day 0 and month 3
novel risk factors neutrophil-to-lymphocyte ratio,
value
Measured: between day 0 and month 3
novel risk factors urinary albumin-to-creatinine ratio
mg/g
Measured: between day 0 and month 3
novel risk factors alkaline phosphatases,
U/L
Measured: between day 0 and month 3
novel risk factors insulin resistance,
value
Measured: between Day 0 and month 3
novel risk factors uric acid,
umol/L
Measured: between day 0 and month 3
novel risk factors D dimer
ng/mL
Measured: between day 0 and month 3
novel risk factors vitamin D deficiency.
ng/mL
Measured: between day 0 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start4 Apr 2019
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Peripheral Arterial DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne BLANCHET, Doctor, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233356
- Sponsor's protocol ID
- PAP_RI2_2017/10
- Acronym
- GWADAOMI
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Risk Factors and Localization of Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT07233356
- Acronym / sponsor ID
- GWADAOMI / PAP_RI2_2017/10
- Keywords
- Hemoglobin A1c, Atherosclerotic peripheral arterial disease, distal localization,, novel risk factors,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 18 Nov 2025 (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.
Background: .Atherosclerotic peripheral arterial disease (PAD) is associated with a high risk of mortality, coronary events and stroke. The distal localization is frequently associated with amputation. Patients from African origin have a higher prevalence of PAD independently of age and other risk factors. In Guadeloupe, French West Indies, infra popliteal localization is more frequent than in France continental associated with different risk factors (88% of hypertension, 2/3 of diabetes).
Purpose: Traditional risk factors of PAD are smoking diabetes, hypertension, high lipid levels, age, and family history of cardiovascular events. The role of novel risk factors in PAD has recently been shown: fibrinogen, CRP-us, homocysteine, interleukin 6, the neutrophil-to-lymphocyte ratio, the urinary albumin-to-creatinine ratio, alkaline phosphatases, insulin resistance, uric acid, D dimer, vitamin D deficiency, HBA1C. Thus the purpose of the research is to study the role of novel risk factors in the occurrence of infrapopliteal PAD. The primary criterion is the HBA1C.
Detailed description
In Guadeloupe, French West Indies, a high prevalence of distal (infra popliteal) PAD has been observed compared to France continental, the risk factors associated with the distal localization are diabetes and hypertension. Novel risk factors in PAD have been highlighted such as fibrinogen, CRP-us, homocysteine, interleukin 6, the neutrophil-to-lymphocyte ratio, the urinary albumin-to-creatinine ratio, alkaline phosphatases, insulin resistance, uric acid, D dimer, vitamin D deficiency. HBA1 C is also an independent novel risk factor of PAD in diabetic and non-diabetic patients. It seems that risk factors are different according to the localization of the disease. Thus the aim of the research is to study the role of novel risk factors in the localization of PAD. The primary outcome is the HBA1C. The secondary outcome is the role of other risk factors in the localization of PAD. This is a cross sectional study. Patients with PAD diagnosed with systolic pressure index< 0.9 or toe systolic pressure < 85 mmHg or tissue oxygen saturation <65 mmHg or with stenosis > 50 % or occlusion will be proposed to participate in the study. If the culprit lesion is infra popliteal they will be included in group 1. If the culprit lesion is supra or popliteal they will be included in group 2. Patients will be informed of the study and the written informed consent will be obtained. Clinical and para clinical date will be taken on the same date (V0). Then the patient will have to go to the Pointe à Pitre hospital within one month for a second visit (V1) where blood and urinary samples will be taken. Interleukin 6 and insulin in non-diabetic and blood collection will specially be taken for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –culprit lesion is infra popliteal |
| group 2 | – | –culprit lesion is supra or popliteal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a Doppler ultra sound for known PAD or newly diagnosed PAD at hospital or at vascular doctor's offices will be proposed to participate in the study. PAD will be diagnosed if systolic pressure index< 0.9 or toe systolic pressure < 85 mmHg or tissue oxygen saturation <65 mmHg or if there is a stenosis > 50 % or an occlusion.. If the culprit lesion is infra popliteal they will be included in group 1. If the culprit lesion is supra or popliteal they will be included in group 2.
Key inclusion criteria (7 listed)
- men or women aged more than 18 years old
- with PAD diagnosed with systolic pressure index (SPI) <0.9 or toe systolic pressure <85 mmHg or tissue oxygen saturation < 65 mmHg or with stenosis >50 % or occlusion of one or more arteries
- Patients with or without diabetes
- with stenosis >50 % or occlusion of one or more arteries, infra popliteal, supra or popliteal
- wishing to take part in the study
Key exclusion criteria (8 listed)
- Patients aged less than 18 years old
- Patients who do not wish to participate in the study
- Patients with PAD with localization infra popliteal and supra popliteal or popliteal (stenosis > 50 % or occlusion of an artery at supra popliteal or popliteal level AND infra popliteal level)
- Patients with an history of revascularization at supra popliteal, popliteal or infra popliteal level AND stenosis on a different territory.
- Patients with medial calcific sclerosis without PAD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemoglobin A1c
Time frame: between day 0 to month 3
pourcentage
10 secondary outcomes
novel risk factors fibrinogen
Time frame: between day 0 and month 3
novel risk factors homocysteine
Time frame: between day 0 an month 3
novel risk factors interleukin 6,
Time frame: between day 0 and month 3
novel risk factors neutrophil-to-lymphocyte ratio,
Time frame: between day 0 and month 3
novel risk factors urinary albumin-to-creatinine ratio
Time frame: between day 0 and month 3
novel risk factors alkaline phosphatases,
Time frame: between day 0 and month 3
novel risk factors insulin resistance,
Time frame: between Day 0 and month 3
novel risk factors uric acid,
Time frame: between day 0 and month 3
novel risk factors D dimer
Time frame: between day 0 and month 3
novel risk factors vitamin D deficiency.
Time frame: between day 0 and month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
Anne BLANCHET, Doctor principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Peripheral Arterial Disease and Hemoglobin A1c Protein, Human, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 18 Nov 2025. 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 Guadeloupe. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: between day 0 to month 3). 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 18 Nov 2025.