Peripheral Arterial DiseaseDIAMACCNCT05646147
DIAbetes Maximal ACCeleration
A study testing Maximal Systolic Acceleration in people with Peripheral Arterial Disease and Diagnosis, run by Leiden University Medical Center.
Trial summary
Prevalence of diabetes mellitus (DM) is increasing rapidly, with patient numbers projected to rise to 643 million by 2030. As a consequence of diabetes-related atherosclerosis, peripheral arterial disease (PAD) and in particular medial arterial calcification (MAC) can occur. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Diagnosis, Diabetic Foot
- What is being tested?
- Maximal Systolic Acceleration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older.
- DM in medical history.
- Presenting with a new-onset wound or ulceration on the foot or ankle with initiation of a new diagnostic care path.
Who cannot join
- Lacking capacity to consent for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Accuracy of the Maximal Systolic Acceleration for Detection of Peripheral Arterial
Prevalence of diabetes mellitus (DM) is increasing rapidly, with patient numbers projected to rise to 643 million by 2030. As a consequence of diabetes-related atherosclerosis, peripheral arterial disease (PAD) and in particular medial arterial calcification (MAC) can occur. The accurate identification of PAD by bedside tests is extremely important in patients with diabetes and foot ulceration, in order to reduce delayed wound healing, prevent lower limb amputation and eventually reduce mortality. However, as shown in previous systematic reviews, the performance of current bedside tests is not reliable in excluding PAD in diabetic patients.1,2 Moreover, the methodological quality of the conducted studies is generally poor. Therefore, more reliable and prospective data is required. Also alternative bedside tests need to be investigated. As an example, the ACCmax (a new doppler derived parameter) could be particularly promising in this patient group.
Read the detailed description
According to the latest 2021 data from the International Diabetes Federation, an estimated 537 million adults are living with DM globally.3 Prevalence is increasing rapidly, with numbers projected to rise to 643 million by 2030 and 783 million by 2045. Annually, DM causes 6.7 million deaths, as a consequence of both macrovascular- (atherosclerosis) and microvascular disease (retinopathy, nephropathy, and neuropathy). In 2021, diabetes caused at least 966 billion dollars in health expenditure, comprising approximately 9% of total spending on adults. Type 2 diabetes comprises about 85-90% of these cases, in which disease onset is often insidious, and diagnosis is consequently delayed.4
Peripheral arterial disease (PAD) of the lower extremity is a clinical manifestation of systemic atherosclerosis and considered a well-known (long-term) complication of DM. Besides atherosclerosis, calcification of the tunica media of the arterial wall can occur. This process is called medial arterial calcification (MAC) and is accelerated in the presence of DM. Research suggests that MAC is present in approximately one third of patients with DM.5 MAC has been shown to be an independent predictor of cardiovascular mortality, while another study found that patients with DM and PAD have an impaired quality of life and an increased risk of adverse cardiac and limb events.6,7
Timely recognition of limb ischemia is important in patients with DM/MAC in order to reduce delayed wound healing, prevent lower limb amputation and eventually reduce mortality.8 Current non-invasive bedside tests - such as the ankle-brachial index (ABI) and toe pressure (TP) - are considered accurate for the diagnosis of PAD. However, as shown in previous systematic reviews, the performance of current bedside tests is not reliable in excluding PAD in diabetic patients.1,2 The methodological quality of the studies in these reviews were poor. In general, most of the data was collected retrospectively and not all patients received reference testing. In order to assess the reliability of bedside tests in this patient group, more well-sound methodological research is required. Also alternative bedside tests need to be investigated.
The doppler derived maximal systolic acceleration (ACCmax) is a new non-invasive parameter, which could be promising in detecting PAD. Although ACCmax has already been used for renal artery stenosis9, thorough evaluation has not been performed in PAD. Two previous studies showed accurate diagnostic property in diabetic patients, but the sample sizes were small.10,11
The aim of this study is to assess the clinical value of bedside tests compared to DUS to detect PAD in patients with diabetes-related foot ulceration, with special emphasis on the ACCmax.
- Conditions
- Peripheral Arterial Disease, Diagnosis, Diabetic Foot
- Being tested
- Maximal Systolic Acceleration
- Keywords
- Peripheral Arterial Disease, Diabetic Foot, Diagnosis
- Medical subject headings
- Peripheral Arterial Disease, Disease, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal Systolic AccelerationDevice
Reliability of the maximal systolic acceleration
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Cohort Study | Other | All patients will underwent full diagnostic testing. Receives: Device: Maximal Systolic Acceleration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of standard bedside tests and the maximal systolic acceleration (ACCmax)
Sensitivity and specificity including their derivates: PLR and NLR
Measured: Through study completion, approximately 1.5 years
Secondary outcomes (3)
Comparison of ACCmax reliability with current bedside tests
Comparison of ACCmax reliability with current bedside tests
Measured: Through study completion, approximately 1.5 years
Comparison of patient demographics (such as age/sex) and comorbidities (duration of diabetes, chronic kidney disease) with diagnostic accuracy of different bedside tests
Comparison of patient demographics (such as age/sex) and comorbidities (duration of diabetes, chronic kidney disease) with diagnostic accuracy of different bedside tests
Measured: Through study completion, approximately 1.5 years
Wound healing and ACCmax
To assess if the maximal systolic acceleration can predict wound healing
Measured: Up to 5 years after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study startJul 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jjwmbrouwers, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646147
- Sponsor's protocol ID
- LUMC-DIAMACC
- Acronym
- DIAMACC
- Status last verified
- Mar 2023
- First submitted
- 20 Nov 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Willems S, Schepers A, Hamming J, Brouwers JJWM. DIAMACC: protocol of a prospective diagnostic accuracy study of the maximal systolic acceleration to detect peripheral arterial disease in patients with diabetes-related foot ulceration in the Netherlands. BMJ Open. 2024 Dec 20;14(12):e086629. doi: 10.1136/bmjopen-2024-086629.
PubMed 39806662
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the Maximal Systolic Acceleration for Detection of Peripheral Arterial
- ClinicalTrials.gov ID
- NCT05646147
- Acronym / sponsor ID
- DIAMACC / LUMC-DIAMACC
- Conditions
- Peripheral Arterial Disease, Diagnosis, Diabetic Foot
- Keywords
- Peripheral Arterial Disease, Diabetic Foot, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 12 Dec 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.
Prevalence of diabetes mellitus (DM) is increasing rapidly, with patient numbers projected to rise to 643 million by 2030. As a consequence of diabetes-related atherosclerosis, peripheral arterial disease (PAD) and in particular medial arterial calcification (MAC) can occur. The accurate identification of PAD by bedside tests is extremely important in patients with diabetes and foot ulceration, in order to reduce delayed wound healing, prevent lower limb amputation and eventually reduce mortality. However, as shown in previous systematic reviews, the performance of current bedside tests is not reliable in excluding PAD in diabetic patients.1,2 Moreover, the methodological quality of the conducted studies is generally poor. Therefore, more reliable and prospective data is required. Also alternative bedside tests need to be investigated. As an example, the ACCmax (a new doppler derived parameter) could be particularly promising in this patient group.
Detailed description
According to the latest 2021 data from the International Diabetes Federation, an estimated 537 million adults are living with DM globally.3 Prevalence is increasing rapidly, with numbers projected to rise to 643 million by 2030 and 783 million by 2045. Annually, DM causes 6.7 million deaths, as a consequence of both macrovascular- (atherosclerosis) and microvascular disease (retinopathy, nephropathy, and neuropathy). In 2021, diabetes caused at least 966 billion dollars in health expenditure, comprising approximately 9% of total spending on adults. Type 2 diabetes comprises about 85-90% of these cases, in which disease onset is often insidious, and diagnosis is consequently delayed.4
Peripheral arterial disease (PAD) of the lower extremity is a clinical manifestation of systemic atherosclerosis and considered a well-known (long-term) complication of DM. Besides atherosclerosis, calcification of the tunica media of the arterial wall can occur. This process is called medial arterial calcification (MAC) and is accelerated in the presence of DM. Research suggests that MAC is present in approximately one third of patients with DM.5 MAC has been shown to be an independent predictor of cardiovascular mortality, while another study found that patients with DM and PAD have an impaired quality of life and an increased risk of adverse cardiac and limb events.6,7
Timely recognition of limb ischemia is important in patients with DM/MAC in order to reduce delayed wound healing, prevent lower limb amputation and eventually reduce mortality.8 Current non-invasive bedside tests - such as the ankle-brachial index (ABI) and toe pressure (TP) - are considered accurate for the diagnosis of PAD. However, as shown in previous systematic reviews, the performance of current bedside tests is not reliable in excluding PAD in diabetic patients.1,2 The methodological quality of the studies in these reviews were poor. In general, most of the data was collected retrospectively and not all patients received reference testing. In order to assess the reliability of bedside tests in this patient group, more well-sound methodological research is required. Also alternative bedside tests need to be investigated.
The doppler derived maximal systolic acceleration (ACCmax) is a new non-invasive parameter, which could be promising in detecting PAD. Although ACCmax has already been used for renal artery stenosis9, thorough evaluation has not been performed in PAD. Two previous studies showed accurate diagnostic property in diabetic patients, but the sample sizes were small.10,11
The aim of this study is to assess the clinical value of bedside tests compared to DUS to detect PAD in patients with diabetes-related foot ulceration, with special emphasis on the ACCmax.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Cohort Study | Other | Device: Maximal Systolic AccelerationAll patients will underwent full diagnostic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older.
- DM in medical history.
- Presenting with a new-onset wound or ulceration on the foot or ankle with initiation of a new diagnostic care path.
Key exclusion criteria (1 listed)
- Lacking capacity to consent for inclusion.
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 |
|---|---|---|
| Maximal Systolic AccelerationReliability of the maximal systolic acceleration | Device | Diagnostic Cohort Study |
Primary outcome
Reliability of standard bedside tests and the maximal systolic acceleration (ACCmax)
Time frame: Through study completion, approximately 1.5 years
Sensitivity and specificity including their derivates: PLR and NLR
3 secondary outcomes
Comparison of ACCmax reliability with current bedside tests
Time frame: Through study completion, approximately 1.5 years
Comparison of patient demographics (such as age/sex) and comorbidities (duration of diabetes, chronic kidney disease) with diagnostic accuracy of different bedside tests
Time frame: Through study completion, approximately 1.5 years
Wound healing and ACCmax
Time frame: Up to 5 years after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 39806662Willems S, Schepers A, Hamming J, Brouwers JJWM. DIAMACC: protocol of a prospective diagnostic accuracy study of the maximal systolic acceleration to detect peripheral arterial disease in patients with diabetes-related foot ulceration in the Netherlands. BMJ Open. 2024 Dec 20;14(12):e086629. doi: 10.1136/bmjopen-2024-086629.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal Systolic Acceleration in people with Peripheral Arterial Disease and Diagnosis, run by Leiden University Medical Center.
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 3 inclusion and 1 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 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Siem Willems, MD (+31642642819, s.a.willems@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of standard bedside tests and the maximal systolic acceleration (ACCmax) (time frame: Through study completion, approximately 1.5 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 NCT05646147, 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 10 Mar 2023.