DIAbetes Maximal ACCeleration

NCT05646147 | Unknown DMC

• 1 other identifier: LUMC-DIAMACC
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Peripheral Arterial Disease; Diagnosis; Diabetic Foot

Keywords

Peripheral Arterial Disease; Diabetic Foot; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Reliability of standard bedside tests and the maximal systolic acceleration (ACCmax)

  Sensitivity and specificity including their derivates: PLR and NLR

  Through study completion, approximately 1.5 years

Secondary Outcomes (3)

• Comparison of ACCmax reliability with current bedside tests

  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

  Through study completion, approximately 1.5 years

• Wound healing and ACCmax

  Up to 5 years after study completion

Study Arms (1)

Diagnostic Cohort Study

OTHER

All patients will underwent full diagnostic testing.

Device: Maximal Systolic Acceleration

Interventions

Maximal Systolic Acceleration DEVICE

Reliability of the maximal systolic acceleration

Diagnostic Cohort Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Related Publications (1)

• 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.

  PMID: 39806662 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Disease; Diabetic Foot

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Siem Willems, MD

CONTACT

+31642642819; s.a.willems@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Resident, MD, PhD-candidate, post-doc

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 12, 2022
• Study Start: July 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share