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NCT05646147
DIAbetes Maximal ACCeleration
Conditions: Peripheral Arterial Disease, Diagnosis, Diabetic Foot
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 238
Sponsor: Leiden University Medical Center
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.
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria:- Lacking capacity to consent for inclusion.
Source: ClinicalTrials.gov (NCT05646147). StuddyBuddy aggregates publicly available trial information.