Peripheral artery disease (PAD) is present in roughly half of people with diabetes-related foot ulcers and is one of the strongest predictors of poor healing and major amputation. When a diabetic foot wound fails to progress because blood flow is inadequate, the decision that matters most is often how, and how quickly, to restore perfusion. Two recent randomized trials, BEST-CLI and BASIL-2, have sharpened that decision, and they reached different conclusions.
Identifying Who Needs Revascularization
Diabetes complicates vascular assessment. Medial arterial calcification can make the ankle-brachial index falsely normal or falsely elevated, and neuropathy can mask classic ischemic symptoms. The 2023 intersocietal guidelines from the International Working Group on the Diabetic Foot (IWGDF), the European Society for Vascular Surgery (ESVS) and the Society for Vascular Surgery (SVS) therefore recommend going beyond pulse palpation and the ankle-brachial index alone. They advise adding toe pressure or toe-brachial index, and transcutaneous oxygen pressure where available, to the assessment of every person with diabetes and a foot ulcer (Fitridge et al., 2023).
The same guidelines advise urgent vascular imaging and consideration of revascularization when toe pressure is below 30 mmHg or transcutaneous oxygen pressure is below 25 mmHg. They also advise considering it when an ulcer has not begun to heal within four to six weeks despite good standard care, regardless of those measurements. Decisions are expected to come from a multidisciplinary team, not from a single discipline.
Staging the Limb and the Anatomy
The Global Vascular Guidelines on chronic limb-threatening ischemia (CLTI) introduced a structured approach that combines patient risk, limb severity and arterial anatomy (Conte et al., 2019). Limb severity is graded with the WIfI system (Wound, Ischemia, foot Infection), while the Global Limb Anatomic Staging System (GLASS) describes the pattern of disease in the femoropopliteal and infrapopliteal segments. The aim is to estimate the benefit of revascularization for a given limb and to match the technique to the patient’s surgical risk, available vein and anatomy, rather than applying a single default strategy.
Bypass Versus Endovascular Therapy: Two Trials
BEST-CLI randomized patients with CLTI to surgical bypass or endovascular therapy, analyzed in two cohorts according to whether an adequate single-segment great saphenous vein was available (Farber et al., 2022). In the cohort with adequate vein (1,434 patients), the composite of major adverse limb events or death occurred in 42.6% of the surgical group and 57.4% of the endovascular group (hazard ratio 0.68; 95% CI 0.59–0.79). Major reinterventions were also less frequent after surgery. In the smaller cohort that required an alternative conduit (396 patients), the two strategies did not differ significantly. Critics have noted the open-label design, the requirement of clinical equipoise for enrolment, and questions about how contemporary endovascular tools were used.
BASIL-2 addressed a narrower, more technically demanding question: patients who needed an infrapopliteal revascularization, randomized to a vein-bypass-first or a best-endovascular-treatment-first strategy (Bradbury et al., 2023). Among 345 participants, amputation-free survival was worse with bypass first (major amputation or death in 63% versus 53%; adjusted hazard ratio 1.35; 95% CI 1.02–1.80), driven mainly by higher all-cause mortality rather than by differences in major amputation alone. Median follow-up was 40 months, and 30-day morbidity and mortality were similar.
These results are not contradictory so much as complementary. BEST-CLI favors bypass when a good vein is available and the patient is fit for surgery, particularly for longer or more complex disease; BASIL-2 suggests that an endovascular-first approach is reasonable for infrapopliteal disease. Both trials enrolled many people with diabetes, but neither was designed specifically around diabetic foot ulcers, so their results are applied to this group with some caution.
Revascularization Is Only One Part of Limb Salvage
Restoring flow does not by itself heal a wound. The IWGDF/ESVS/SVS guidelines emphasize that infection control, debridement, offloading and glycemic management proceed alongside revascularization, and that success should be judged by wound healing and limb preservation rather than by patency alone. Infection in an ischemic foot is an emergency, and drainage or debridement should not be delayed while vascular imaging is arranged (Fitridge et al., 2023).
Key Takeaways
In diabetes, a normal ankle-brachial index does not exclude PAD, and toe pressure or transcutaneous oxygen measurement improves detection. Low toe pressure or a non-healing ulcer should prompt timely vascular imaging and team-based review. Limb staging with WIfI and GLASS supports individualized strategy. Current trial evidence favors surgical bypass in patients with adequate saphenous vein who are suitable for surgery (BEST-CLI), and supports an endovascular-first approach for infrapopliteal disease (BASIL-2). Revascularization works best as part of coordinated wound, infection and offloading care.
References
- Bradbury AW, 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): an open-label, randomised, multicentre, phase 3 trial. The Lancet, 2023.
- Conte MS, et al. Global Vascular Guidelines on the management of chronic limb-threatening ischemia. Journal of Vascular Surgery, 2019.
- Farber A, et al. Surgery or endovascular therapy for chronic limb-threatening ischemia (BEST-CLI). New England Journal of Medicine, 2022.
- Fitridge R, et al. The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer. European Journal of Vascular and Endovascular Surgery, 2023.
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