Effectiveness of revascularisation for the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review

Abstract

IntroductionPeripheral artery disease (PAD) is associated with an increased likelihood of delayed or non‐healing of a diabetes‐related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality.MethodsTitle and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case‐control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk‐of‐bias tool for randomised trials, the ROBINS‐I tool for non‐randomised studies, and Newcastle‐Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided.ResultsFrom a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61–0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions.ConclusionsThe majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach.

Healing Following Revascularization—Unlocking Skin Potential

“…Ischemic wounds of the lower extremity represent an advanced stage of peripheral arterial disease (PAD), namely chronic limb-threatening ischemia (CLTI). [1][2][3][4] CLTI is linked with high amputation rates, which reduce the quality of life for PAD patients. [5][6][7] Improved understanding and translating of knowledge about wound healing of CLTI patients is very important.…”

The unique multidisciplinarity of diabetes‐related foot disease

“…The information in the practical guidelines is based on the 7 evidence-based guidelines, each describing in detail the recommendations on their specific topic, that is, prevention, 4 classification, 5 infection, 6 peripheral artery disease, 7 offloading, 8 wound healing, 9 and Charcot's neuro-osteoarthropathy 10 . The evidence underlying these recommendations is described in 11 systematic reviews of the literature, [11][12][13][14][15][16][17][18][19][20][21] collectively having screened >100,000 publications. For full transparency, the methodology is described in even more detail in a separate document 22 and, to further ensure a shared language, detailed definitions and criteria are also provided.…”