Characteristics and Outcome for Persons with Diabetic Foot Ulcer and No-Option Critical Limb Ischemia

Abstract

The study aimed to evaluate clinical and vascular characteristics, as well as outcomes, for diabetic persons with foot ulceration and no-option critical limb ischemia (CLI). The study group included a sample of patients admitted to our diabetic foot unit because of a new diabetic foot ulcer and CLI. All subjects were managed using a limb salvage protocol which includes lower-limb revascularization. According to whether or not the revascularization procedure was a success, patients were respectively divided into two groups: successfully treated CLI patients (ST-CLI) and no-option CLI patients (NO-CLI). Failed revascularization was considered in the case of technical recanalization failure of occluded vessels (inability to overcome the obstruction) and/or absence of arterial flow to the foot. Limb salvage, major amputation, and death after 1 year of follow-up were evaluated and compared between the two groups. Overall, 239 patients were included, 74.9% belonging to ST-CLI and 25.1% to NO-CLI. NO-CLI patients reported more cases of ischemic heart disease (80 vs. 62.1, p = 0.008), heart failure (63.3 vs. 32.4%, p < 0.0001), and end-stage renal disease (ESRD) (60 vs. 25.7%) than ST-CLI patients. In addition, more vessels were affected in the NO-CLI group (5.2 ± 1.6 vs. 4 ± 1.5, p < 0.0001), and there was more involvement of tibio-peroneal trunk (50 vs. 30.2%, p = 0.006), anterior tibial (93.3 vs. 82.7, p = 0.03), posterior tibial (93.3 vs. 73.7%, p = 0.0005), peroneal (70 vs. 48%, p = 0.002), and below-the-ankle arteries (73.3 vs. 39.1%, p < 0.0001) than ST-CLI. The 1 year outcomes for the whole population were 69.9% limb salvage, 10.9% major amputation, and 19.2% death. The outcomes for NO-CLI and ST-CLI were, respectively, as follows: limb salvage (13.8 vs. 73.4%, p < 0.0001), amputation (30 vs. 4.5%, p = 0.0001), and mortality (50 vs. 8.9%, p < 0.0001). NO-CLI patients showed a more severe pattern of peripheral arterial disease (PAD) with distal arterial lesions and worse outcomes than ST-CLI.

Foot Revascularization Avoids Major Amputation in Persons with Diabetes and Ischaemic Foot Ulcers

“…However, our study showed also that a great number of patients with BTA arterial disease (approximately 40%) are not-treatable subjects reporting an unsuccessful foot revascularization procedure. FFP patients were in 50% on dialysis and it could justify the higher rate of revascularization failure as reported in previous studies [22,23].…”

“…Among patients with ischaemic DFUs, approximately 25% are defined as no-option critical limb ischaemia (NO-CLI) which have a rate of 25-30% of major amputation due to the unsuccessful lower limb revascularization [22,23,25]. NO-CLI subjects are usually characterized by a multilevel arterial disease with the high involvement of foot arteries (approximately in 75% of cases) [23].…”

Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients with No-Option Critical Limb Ischemia

“…Recently, Meloni et al reported a 30% amputation rate and 50% mortality rate for NO-CLI diabetic patients at 1 year follow-up in a retrospective cohort study [4]. Few diseases connote a higher mortality rate: among 22 different types of malignancy, only six have a 5-year mortality rate higher than that of CLI [29].…”

“…Limb salvage is associated with percutaneous or surgical revascularization, in comparison to the medical treatment in patients with peripheral arterial disease (PAD) and diabetic foot ulcers (DFUs) [2]. However, up to 25% of diabetic patients are not eligible for revascularization as a result of the inability to overcome vessel obstruction and/or for critical general conditions [3,4]. Of the one million annual amputations worldwide, 75% are performed on patients with type 2 diabetes (T2DM) [5].…”

“…Of the one million annual amputations worldwide, 75% are performed on patients with type 2 diabetes (T2DM) [5]. No-option critical limb ischemia (NO-CLI) remains a strong unmet clinical need: at 1 year follow-up, NO-CLI diabetic patients showed, respectively, lower rates of limb salvage (13.8% vs. 73.4%, p < 0.0001), higher rates of amputation (30% vs. 4.5%, p = 0.0001), and higher mortality rates (50% vs. 8.9%, p < 0.0001) in comparison to revascularizable CLI patients [4]. Autologous cell therapy, and the use of autologous PBMNCs in particular, has arisen as a possible strategy to treat NO-CLI patients as well as diabetic foot patients [6][7][8][9].…”