Sofortige Wiederherstellung der arteriellen Blutversorgung (Revaskularisation) versus alleinige Standardversorgung bei Patient*innen mit Diabetes und Wunde am Fuss welche sehr schnell zu Komplikationen führen kann (diabetisches Fussulkus) und nicht-kritischer Durchblutungsstörung: eine randomisierte kontrollierte Studie

Procedure: Revascularization;Procedure: Standard wound care

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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 the
ruler method multiplying the greatest length and width of the ulcer after debridement
to determine the surface area. The largest eligible ulcer (= 10 cm2) will be defined
as index ulcer and the corresponding extremity as index limb (in case of multiple
equally sized ulcers the following rules will apply: If on different feet, the
dominant side and if on the same foot, the more peripheral one will be the index
ulcer)

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

- Ankle brachial index (ABI) = 0.5 and = 0.9 AND absolute ankle pressure = 50 mmHg
OR

- ABI > 0.9 OR incompressible ankle pressures AND toe brachial index (TBI) = 0.7
AND absolute toe pressure = 30 mmHg

- Patients on medical treatment for glycemic control with diagnosis of diabetes mellitus
that was assessed by criteria as recommended by the guideline 2019 "ESC Guidelines on
diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with
the EASD". Or patient without medical treatment but diagnosed with diabetes mellitus
via HbA1c.

- Patients with life expectancy > 12 months and without any disabilities due to
end-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 ankle
pressure < 50 mmHg)

- No option to assess for toe pressure due to any reason at baseline if ABI > 0.9 or
incompressible ankle pressures and patient inclusion is based on the toe pressure
criteria.

- Need for major amputation

- Severe infection at the index foot according to IDSA classification

- Patient refuses minor amputation despite strong recommendation due to severe
infection, necrosis or osteomyelitis at screening assessment

- Any revascularization procedure at the index leg within 3 months before randomization

- Positive urine or blood pregnancy test result, breast feeding or intention to become
pregnant

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

- Participation in another drug study within the 30 days preceding or during the present
study

- Untreated known antiphospholipid antibody syndrome and polycythaemia vera

- Known significant bleeding risk, or known coagulation disorder (INR > 3.0 and platelet
count < 30,000/mm3) without any option to correct within 7 calendar days after initial
wound assessment