Position Paper of the German Diabetes Association, German Society of Angiology and Vascular Medicine, German Society for Vascular Surgery and Vascular Medicine and German Society for Interventional Radiology and Minimally Invasive Therapy on the Diagnosis and Treatment of Peripheral Arterial Occlusive Disease in Diabetes Mellitus

Position paper of the DDG, DGA, DGG and DeGiR on the Diagnosis and Treatment of PAOD in Diabetes Mellitus German Diabetes Association : Clinical Practice Guidelines This is a translation of the DDG clinical practice guideline published in Diabetol Stoffwechs 2025; 20: S454–S467. DOI: 10.1055/a-2593-4467. Notice of update The DDG clinical practice guidelines are updated regularly during the second half of the calendar year. Please ensure that you read and cite the respective current version. UPDATES TO CONTENT AND DIFFERENT RECOMMENDATIONS COMPARED TO THE PREVIOUS YEAR’S VERSION Change 1: Drug therapy of symptomatic peripheral arterial occlusive disease (PAOD) in stage II (claudication) in people with diabetes. Reason: Improvement of walking performance, quality of life and reduction of major adverse limb event in people with diabetes and PAOD in the intermittent claudication stage with weekly therapy with semaglutide (1 mg/wk s.c.) Supporting reference: [ 1​ ] Change 2: Recommendations for intermittent claudication modified with emphasis on structured gait training Reason: New 2024 S3 guideline on PAOD Supporting reference: [ 2​ ] Change 3: Update of interventional treatment recommendations for the aorto-iliac, femoro-popliteal and cruro-pedal vascular segments Reason: Adaptation of the recommendations according to current data and guideline Supporting reference: [ 2​ ] Change 4: Critical limb-threatening ischaemia Reason: Adaptation of the recommendations according to current data and guideline Supporting reference: [ 2​ ] [ ​3​ ] This clinical practice recommendation is based on the current German and international guideline recommendations [ 2​ ] [ ​4​ ] and serves as a short, clinically oriented guideline for the diagnosis and treatment of patients with diabetes mellitus (DM) and peripheral arterial occlusive disease (PAOD). Peripheral circulatory disorders of the pelvic and leg arteries are one of the secondary complications suffered by patients with diabetes. The term covers stenoses, occlusions and—to a lesser extent—aneurysmal vascular changes of the pelvic leg arteries. Arterial vascular lesions occur mostly in later life; however, people with diabetes are often affected prematurely. In these patients, the time of the initial manifestation also depends on the duration of the disease and the quality of metabolic control. Only 25% of affected patients have symptoms. Especially, in patients with diabetes, atheromatosis of the peripheral vessels is aggravated by chronic inflammatory vessel wall processes and hypercoagulability. Second to nicotine abuse, diabetes is the most important risk factor for the occurrence of PAOD.[ 5​ ] [ ​6​ ] Patients with diabetes have a two to four-time higher risk of developing PAOD than patients without diabetes. Up to 30% of all patients with claudication and 50% of all patients with critical limb-threatening ischaemia (CLTI) are people with DM.[ 7​ ] PAOD patients with diabetes have specific anatomical–morphological and clinical characteristics which must be considered in the diagnostic and therapeutic approach. Compared to people without DM, PAOD in people with DM develops earlier, progresses more rapidly and changes over more frequently to CLTI. Anatomically–morphologically, a multi-segmental manifestation with long, calcified stenoses/occlusions of the lower leg arteries with insufficient collateral formation is typical. Clinically, people with diabetes often first consult their doctors because of a critical ischaemia, in part because the intermittent claudication preceding a critical ischaemia and the pain at rest can remain masked for a long time by the diabetic sensory polyneuropathy (PNP). The prognosis for a life without amputations is poor for people with DM. On the one hand, this is due to the high ischaemia and ulcer recurrence rates and the associated minor and major amputations. On the other hand, it results from the high rate of comorbidities and co-prevalence of target organ damage such as cardiac and renal insufficiency, each of which on its own increases mortality. The most significant consequences of diabetic peripheral circulatory disorders are foot lesions (ulcers and gangrene) and minor and major amputations as a result of ischaemic or neuroischaemic diabetic foot syndrome (DFS; [ Table 1​ ]). Table 1 Classification of the peripheral arterial occlusive disease (PAOD) according to Fontaine and Rutherford Fontaine Rutherford Stage Clinical picture Degree Category Clinical picture I Asymptomatic 0 0 Asymptomatic IIa Walking distance >200 m I 1 Mild IC IIb Walking distance <200 m I 2 Moderate IC I 3 Severe IC III Ischaemic pain at rest II 4 Ischaemic pain at rest IV Ulcer and gangrene III 5 Small patch necrosis III 6 Large patch necrosis Abbreviation: IC, intermittent claudication. WHAT DOES IT MEAN? The number of patients with peripheral arterial occlusive disease (PAOD) and diabetes is constantly increasing. The risk of amputation in people with diabetes mellitus is significantly increased when PAOD is present. Timely detection of PAOD reduces the amputation and cardiovascular event rates if treatment is in accordance with guidelines. Interdisciplinary cooperation and rapid revascularisation are crucial in critical limb-threatening ischaemia. Diagnostics of peripheral arterial occlusive disease in people with diabetes mellitus Non-invasive haemodynamic vascular function diagnostics in people with DM allows conclusions to be drawn about the severity of the circulatory disorder and provides prognostic information on the spontaneous course, cardiovascular (CV) risk and/or wound healing. Target-oriented diagnostics facilitate choosing the appropriate therapy and enable monitoring of the course of the disease during and after vascular treatment. VASCULAR DIAGNOSTICS FOR PEOPLE WITH DIABETES MELLITUS Clinical examination including recording of pulse status and capillary pulse as well as a qualitative comparison of skin colour and temperature Doppler ankle or toe pressure measurement (ankle-brachial index [ABI]); toe-brachial index [TBI]) Colour-coded duplex sonography with pulse curve analysis Pulse oscillography of the digital arteries (DPO) or light reflection rheography (LRR) Transcutaneous oxygen measurement (tcPO 2 ) In people with DM, these non-invasive diagnostic procedures should be used liberally if there is a suspicion of PAOD, or if a foot lesion is present or is not healing. In the clinical examination, it is important to examine the reactive skin circulation of the feet (capillary pulse) as well as perform the palpation of foot pulses. Although the pulse examination of lower extremities is helpful, the frequency of the PAOD is overestimated in the absence of pulses. Conversely, palpable foot pulses do not rule out the presence of PAOD. The capillary pulse as a reactive filling of the skin after pressure indicates the presence of a critical circulatory problem. People with diabetes mellitus with peripheral arterial occlusive disease should have a regular clinical foot examination Ankle-brachial index (ABI) is determined using non-invasive doppler ultrasound to measure blood pressures at rest and/or after exertion and is a suitable test for detecting PAOD. Decreased peripheral pressure values are evidence of the presence of PAOD and indicate the CV risk in the patient. The ABI value with the lowest ankle artery pressure is decisive for the diagnosis of PAOD. An ABI value at rest below 0.9 is a deemed confirmation of the presence of PAOD. Nevertheless, normal values of the ABI cannot reliably rule out PAOD in the case of parallel DM, as calcification of the media can lead to false high values. The pulse curve analysis, pulse oscillography of the digital arteries and toe pressure measurement with the determination of the toe-brachial index (TBI) are of particular importance and are used for confirming PAOD [ 2​ ] [ ​4​ ] in the presence of classic media sclerosis (ABI >1.3) Ankle-brachial index measurement is important for confirming the peripheral arterial occlusive disease and risk vascular must be if ABI of toe pressures of ankle pressures of or a oxygen pressure (tcPO 2 ) value of is determined in patients with 2​ ] In such the risk of developing a foot ulcer is increased Table 2​ ]). Table 2 and prognosis of PAOD based on Doppler values. according to [ 2​ ] [ ] [ ] ABI pressure pressure PAOD sclerosis of wound chronic limb-threatening PAOD, peripheral arterial occlusive foot ischaemia also be present with palpable foot pulses or normal toe pressure values lesion in people with DM Non-invasive haemodynamic of the leg vessels are to course and therapy in patients with PAOD. and digital should be in symptomatic or patients if there is therapeutic to the of people with DM and diagnostics and therapy are DIAGNOSTICS Colour-coded duplex sonography of the pelvic leg arteries of the pelvic leg arteries with or 2 Colour-coded duplex sonography is of particular importance as a non-invasive haemodynamic results with and allows to be on the and of vascular there are using or is however, it is important to of and should be in for in the case of a or to and a vascular The renal function in people with DM a in the of with the or used significantly and of the patients must be 2 can be used in procedures and a for renal In lower leg it is by the of a of a The for diagnostics should be on of peripheral arterial occlusive disease in people with diabetes mellitus of therapy The therapy of PAOD in people with DM two the of peripheral blood in symptomatic patients as well as the therapy of vascular risk and with of and [ 3 ] and [ ]). Table 3 Treatment Stage of PAOD Fontaine Rutherford of risk training reduction of cardiovascular Fontaine Rutherford of risk training Improvement of walking and quality of life as well as pain reduction Fontaine II Rutherford of risk training reduction of peripheral vascular Fontaine Rutherford of vascular of ischaemia the leg Fontaine Rutherford of minor or major amputation Abbreviation: PAOD, peripheral arterial occlusive Table 4 therapy according to [ 2​ ] Fontaine I II III IV factor diabetes blood pressure treatment or structured vascular for people with diabetes mellitus Drug or wound treatment therapy therapy of high and suitable vascular in stage The treatment for to Fontaine stage 3 structured gait training also in for people with for walking or and are as as gait In to vascular reduction in of nicotine in and the treatment of arterial and DM are therapeutic treatment in people with DM with symptomatic PAOD the of or is to 2​ ] the risk of ischaemia and In to which is in symptomatic PAOD, the of is in all of PAOD, with a target value of and at a 50% reduction in the value to the 2​ ] therapy for peripheral arterial occlusive disease Patients with symptomatic with or as a secondary its to in symptomatic PAOD ] should not be to patients with CV 7​ ] [ ] [ ] [ ] [ ] and this is also for PAOD 2​ ] therapy with and not present over with ] therapy with to 5​ ] can be in to a of 6 2​ ] patients with symptomatic PAOD after revascularisation and a high risk of ischaemic a therapy with and a reduction of the major adverse CV event and CV and major adverse limb event circulatory ] This to patients with DM. 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