Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Features and Prevalence of Asymptomatic Peripheral Artery Disease in Patients With Type 1 Diabetes Mellitus
Brief Summary: AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the current recommendations regarding for PAD screening in T1DM.

METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for detecting classic symptoms of intermittent claudication, and after verifying the absence of symptoms and exclusion criteria, they will be included in the study. All patients will undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk factors, as well as, an analytical assessment of the lipid profile, HbA1c level, proinflammatory profile and oxidative stress status. They will also undergo a comprehensive anthropometric assessment including office blood pressure (BP) monitoring and ambulatory 24-hours BP monitoring in patients with an indication as routine clinical practice, assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler ultrasound, in the context of routine clinical practice in patients with clinical indication, or as an extraordinary procedure for participating in the study in patients who do not meet criteria for screening according to current recommendations.


Options:
A: Inclusion Criteria:

* Male and Female patients 50 years old or older Symptomatic peripheral artery disease

Exclusion Criteria:

* Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation
* Patients with known bleeding disorders
* Patients with a history of intracranial bleed
* Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
B: Inclusion Criteria:

* All diabetic patients presenting to the diabetic foot clinics will be eligible for the study.

Exclusion Criteria:

* Patients unable to provide informed consent will also be excluded.
C: Inclusion Criteria:

* Previous diagnosis of T1DM before 30 years of age.

DM diagnostic criteria:

* DM cardinal symptoms (polyuria, polydipsia, unexplained weight loss) with plasma glucose ≥ 200 mg / dl, or diagnosis as diabetic ketoacidosis (DKA).
* fasting plasma glucose (≥ 8 h) ≥ 126 mg / dl.
* plasma glucose at 2 h in testing oral glucose tolerance test (75 g glucose) ≥ 200 mg / dl.
* glycosylated hemoglobin (HbA1c) ≥ 6.5% \[as certified by the National method Glycohemoglobin Standardized Program (NGSP) and standardized according to the Diabetes Control and Complication Trial trial (DCCT)\].

The criteria b, c and d require confirmation, except in cases of hyperglycemia with acute decompensation (criteria a).

* Positive determination of a autoantibody serum markers of immune destruction against antigens cytoplasm of the islet cells (ICA), anti-insulin (AAI), and / or anti protein glutamate decarboxylase (GADA) at initial diagnosis time or during the course of the disease.

Acceptance of participation in the study and sign the informed consent.

Exclusion Criteria:

* Prior diagnosis of PAD, diabetic foot, leg amputation or symptoms in line with PAD according to the Edinburgh questionnaire for intermittent claudication.
* Diagnosis of type 2 diabetes, gestational diabetes, latent autoimmune diabetes in adults (LADA) or maturity-onset diabetes of youth (MODY) diabetes.
* Current pregnancy, institutionalized or terminal illness subjects.
* Refusal to participate in the study or to sign the informed consent.
D: Inclusion Criteria:

* presence of Diabetic Foot in patients with type 1 or type 2 diabetes mellitus, with WIfI classification of ischemia 1-2 (based on TcPO2) without previously diagnosed PAD or with known PAD based on the patients' history or previous vascular reconstruction (endovascular or surgical vascular interventions)
* resting TcPO2 values between 30-50 mm Hg.

Exclusion Criteria:

* vascular interventions on evaluated limb within 12 months prior to the enrolment into the study
* factors possibly influencing for example oxygen saturation or feet movement:

  * patient imobility
  * impairment of movements at the talocrural joints
  * vasculitis
  * heart failure or advanced COPD
  * severe anaemia (plasma haemoglobin below 8g / dL)
  * hypoperfusion due to shock or cardiac dysfunction
  * sepsis
  * massive swelling of the lower limbs of various ethiology (including lymphedema)
  * active Charcot osteoarthropathy
  * critical limb ischemia with WIfI classification of ischemia 3
  * lower limb claudication below 200m
  * venous insufficiency of CEAP classification 6
  * severe diabetic kidney disease (CKD stage 4 or 5)

Answer: C