Timing of Revascularization in Patients With Diabetic Foot Ulcer and Non-critical Peripheral Artery Disease

Inclusion Criteria:

• Informed consent as documented by signature

• Patients that are at least 18 years old

• Patients that have at least one DFU(s) of ≥ 0.2 cm2 and ≤ 10 cm2 as assessed by theruler method multiplying the greatest length and width of the ulcer afterdebridement to determine the surface area. The largest eligible ulcer (≤ 10 cm2)will be defined as index ulcer and the corresponding extremity as index limb (incase of multiple equally sized ulcers the following rules will apply: If ondifferent feet, the dominant side and if on the same foot, the more peripheral onewill be the index ulcer)

• Patients that have non-critical LEAD of the index leg, defined by a singlenon-invasive examination at screening:

• Ankle brachial index (ABI) ≥ 0.5 and ≤ 0.9 AND absolute ankle pressure ≥ 50mmHg OR

• ABI > 0.9 OR incompressible ankle pressures AND toe brachial index (TBI) ≤ 0.7AND absolute toe pressure ≥ 30 mmHg

• Patients on medical treatment for glycemic control with diagnosis of diabetesmellitus that was assessed by criteria as recommended by the guideline 2019 "ESCGuidelines on diabetes, pre-diabetes, and cardiovascular diseases developed incollaboration with the EASD". Or patient without medical treatment but diagnosedwith diabetes mellitus via HbA1c.

• Patients with life expectancy > 12 months and without any disabilities due toend-stage cancer, heart failure, severe chronic obstructive pulmonary disease (COPD), or dementia

Exclusion Criteria:

• Critical limb ischemia of the index leg defined as ABI ≤ 0.4 (or absolute anklepressure < 50 mmHg)

• No option to assess for toe pressure due to any reason at baseline if ABI > 0.9 orincompressible ankle pressures and patient inclusion is based on the toe pressurecriteria.

• Need for major amputation

• Severe infection at the index foot according to IDSA classification

• Patient refuses minor amputation despite strong recommendation due to severeinfection, necrosis or osteomyelitis at screening assessment

• Any revascularization procedure at the index leg within 3 months beforerandomization

• Positive urine or blood pregnancy test result, breast feeding or intention to becomepregnant

• Non-compliance for any reason to procedures or study assessments (e.g. due tocognitive impairment or geographic distance)

• Participation in another drug study within the 30 days preceding or during thepresent study

• Untreated known antiphospholipid antibody syndrome and polycythaemia vera

• Known significant bleeding risk, or known coagulation disorder (INR > 3.0 andplatelet count < 30,000/mm3) without any option to correct within 7 calendar daysafter initial wound assessment