Peripheral artery disease (PAD) is present in a substantial share of people with diabetic foot ulcers and is one of the strongest determinants of whether a wound heals or ends in major amputation. Diabetes tends to produce disease in the tibial and pedal arteries below the knee, where restoring blood flow is technically demanding. Two large randomized trials published in 2022 and 2023, together with the 2023 IWGDF/ESVS/SVS guideline, have refined how clinicians think about revascularization for chronic limb-threatening ischemia (CLTI). This article summarizes what that evidence shows.
When Is Revascularization Considered?
The 2023 IWGDF/ESVS/SVS guideline on PAD in people with diabetes and a foot ulcer (Fitridge et al., 2023) recommends that revascularization be considered when a foot ulcer is accompanied by absent pulses, monophasic or absent pedal Doppler waveforms, an ankle pressure below 100 mmHg, or a toe pressure below 60 mmHg. Urgent vascular consultation is advised for severe ischemia, defined by an ankle-brachial index below 0.4, ankle pressure below 50 mmHg, toe pressure or transcutaneous oxygen pressure (TcPO2) below 30 mmHg, or absent pedal flow.
The guideline also sets a time-based trigger: if a wound shows less than a 50% reduction in area after four weeks despite optimal standard care, vascular status should be reassessed. Its rationale notes that delaying revascularization beyond two weeks is associated with more limb loss, while revascularization within eight weeks is associated with higher healing rates. In patients with infection or gangrene, drainage and source control come first, with revascularization generally following within a few days once sepsis is controlled.
Bypass Versus Endovascular Therapy: Two Trials
BEST-CLI
The BEST-CLI trial (Farber et al., New England Journal of Medicine, 2022) randomized 1,830 patients with CLTI to surgical bypass or endovascular therapy. In cohort 1, 1,434 patients with an adequate single-segment great saphenous vein, the composite primary outcome of major adverse limb events (above-ankle amputation or index-limb reintervention) or death occurred in 42.6% of the surgical group versus 57.4% of the endovascular group (hazard ratio 0.68; 95% CI 0.59–0.79). The difference was driven largely by fewer reinterventions after bypass, while mortality did not differ meaningfully. In cohort 2, where an alternative conduit was needed, no significant difference was found (HR 0.79; 95% CI 0.58–1.06).
BASIL-2
BASIL-2 (Bradbury et al., The Lancet, 2023) addressed patients with infrapopliteal disease and randomized 345 patients to a vein-bypass-first or a best-endovascular-treatment-first strategy. The primary outcome was amputation-free survival. It was worse with vein bypass first (adjusted HR 1.35; 95% CI 1.02–1.8), a difference associated mainly with higher all-cause mortality in the bypass arm (HR 1.37; 95% CI 1.00–1.87), whereas major adverse limb events were similar between strategies.
Reconciling the Results
The trials differ in population, anatomy, and endpoints, so their findings are not directly contradictory. BEST-CLI enrolled patients with a wide range of disease patterns and measured limb events plus death, whereas BASIL-2 was restricted to infrapopliteal disease and used amputation-free survival. Based largely on BEST-CLI, the IWGDF guideline suggests bypass over endovascular therapy when an adequate single-segment saphenous vein is available and the patient is suitable for either approach (conditional recommendation). It also stresses that treatment occur in centers with both endovascular and bypass expertise, with the choice guided by patient risk and preference, limb threat, anatomy, and vein availability.
Technical Goals and Expected Outcomes
The guideline advises imaging the entire arterial tree from aorta to foot, including the below-knee and pedal arteries, and aiming to restore in-line flow to at least one foot artery. For endovascular procedures, targeting the artery supplying the ulcer’s angiosome may be considered where feasible, although the supporting evidence is rated very low certainty. After revascularization, perfusion adequacy should be confirmed objectively, for example with bedside non-invasive testing.
The guideline’s rationale cites limb salvage of roughly 80–85% and ulcer healing in more than 60% of patients at 12 months after revascularization, compared with limb salvage near 50% at one year in suitable patients who were not revascularized. Outcomes are poorer in end-stage renal disease, with one-year mortality of about 40% and limb salvage of about 70%. Revascularization is not appropriate for every patient: it is discouraged when the balance of risk and benefit is clearly unfavorable, such as in very frail individuals, those with limited life expectancy, or when the foot is unlikely to be salvageable. The Global Vascular Guidelines (Conte et al., 2019) similarly frame decisions around the patient’s risk, the severity of limb threat, and anatomic complexity.
Key Takeaways
Revascularization is one component of multidisciplinary care that also includes infection control, debridement, offloading, glycemic management, and nutrition. Timely perfusion assessment and prompt vascular referral for non-healing or severely ischemic wounds are supported by current guidance. Randomized evidence suggests that bypass with good-quality saphenous vein may reduce limb events and reinterventions in suitable patients, whereas an endovascular-first approach may be favored in infrapopliteal disease, particularly when surgical risk is high. Individual decisions depend on anatomy, vein quality, comorbidity, and institutional expertise.
References
- Fitridge R, Chuter V, Mills J, et al. The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer. Diabetes/Metabolism Research and Reviews. 2023.
- Farber A, Menard MT, Conte MS, et al. Surgery or endovascular therapy for chronic limb-threatening ischemia (BEST-CLI). N Engl J Med. 2022;387:2305–2316.
- Bradbury AW, Moakes CA, Popplewell M, et al. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2). The Lancet. 2023;401:1798–1809.
- Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019;69(6S):3S–125S.
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