Diabetes And Chronic Limb Ischaemia And Revascularization

BACKGROUND: Revascularization is the primary treatment modality for chronic limb-threatening ischaemia (CLTI), but is not feasible in all patients. PLX-PAD is an off-the-shelf, placental-derived, mesenchymal stromal cell-like cell therapy. This study aimed to evaluate whether PLX-PAD would increase amputation-free survival in people with CLTI who were not candidates for revascularization. METHODS: People with CLTI and minor tissue loss (Rutherford 5) who were unsuitable for revascularization were entered into a randomized, parallel-group, placebo-controlled, multinational, blinded, trial, in which PLX-PAD was compared with placebo (2 : 1 randomization), with 30 intramuscular injections (0...

The triad of ischaemia, neuropathy, and infection are among the principal causes of lower extremity wounds that are commonly prevalent in patients with diabetic foot (DF) a condition in which peripheral arterial disease commonly co-exists. The prevalence of this condition is increasing globally and with it, the mounting costs of its management. One aspect of management is saving limbs and or digits, a crucial part of this process is assessing tissue viability of skin which is a focus of this review: there are other aspects which are well described in the literature...

Chronic limb-threatening ischaemia (CLTI) is a severe form of peripheral arterial disease (PAD) and is associated with an increased risk of amputation, mortality, and significantly impaired quality of life. International guidelines recommend considering timely revascularisation and optimal medical therapy to improve limb perfusion in individuals with CLTI. The 2 primary revascularization approaches for CLTI are open bypass surgery (BS) and endovascular therapy (EV), however, there is currently no consensus on the best initial treatment strategy for CLTI, leading to uncertainty among clinicians...

BACKGROUND: Diabetic foot ulcer (DFU) is a serious chronic complication of diabetes mellitus that contributes to 85% of nontraumatic lower extremity amputations in diabetic patients. Preliminary clinical benefits have been shown in treatments based on mesenchymal stem cells for patients with DFU or peripheral arterial disease (PAD). However, the long-term safety and benefits are unclear for patients with both DFU and PAD who are not amenable to surgical revascularization. METHODS: In this phase I pilot study, 14 patients with PAD and incurable DFU were enrolled to assess the safety and efficacy of human umbilical cord mesenchymal stem cell (hUC-MSC) administration based on conservative treatments...

BACKGROUND: Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians. METHODS: A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC). RESULTS: AC included 49 patients with 77 lesions...

This study investigated the distribution of risk factors, lesion characteristics and endovascular revascularization (EVR) strategies in patients with peripheral arterial disease (PAD) with vs without diabetes mellitus (DM). Data were collected within the RECcording COurses of vasculaR Diseases (RECCORD) registry. Demographic data, lesion localization (iliac vs femoropopliteal vs below-the-knee (BTK)) and lesion complexity score (LCS) based on number of affected segments, and lesion length (< 10 vs 10-20 vs > 20 cm), EVR strategies and peri-procedural complications were analysed in 786 patients with and 1337 without diabetes mellitus...

AIMS: The prevalence of chronic limb-threatening ischaemia (CLTI) is increasing and available data often derive from cohorts with various selection criteria. In the present study, we included CLTI patients and studied sex-related differences in their risk profile, vascular procedures, and long-term outcome. METHODS AND RESULTS: We analysed 199 953 unselected patients of the largest public health insurance in Germany (AOK: Local healthcare funds), hospitalized between 2010 and 2017 for a main diagnosis of CLTI...

Natrox™ topical oxygen therapy (TOT) ( Inotec AMD Ltd , Hertfordshire, UK) employs a small battery-powered "oxygen generator" to concentrate atmospheric oxygen and feeds pure, moist, oxygen through a fine, soft tube to a dressing-like "oxygen distribution system", which is placed over the wound and is held in place by a conventional dressing. The aim was to determine the effectiveness of Natrox™ for non-healing diabetic foot ulcers (DFU) over a 3-month period.Longitudinal, single-arm, open prospective registry study using 12 weeks of TOT using a 4 week run-in period...

This study aimed to examine the distribution of lower limb atherosclerotic lesions in a multi-ethnic Asian cohort with chronic limb threatening ischemia (CLTI) from Singapore. The Society for Vascular Surgery Vascular Quality Initiative registry database was used to identify 265 CLTI patients who underwent percutaneous angioplasty between June 2019 and December 2019, of whom 171 (64.5%) were male, and the mean age was 67.9±11.0 years. The majority were diabetic (84.5%) and 145 (54.7%) had chronic kidney disease (CKD)...

OBJECTIVES: Revascularization according to the angiosome concept is of proven importance for limb salvage in chronic limb threatening ischaemia but it is not always practicable. Bifurcated bypasses could be considered as an option when an endovascular approach is not feasible or has already failed and a single bypass would not allow direct revascularization of the ischaemic area. Bifurcated bypasses are characterized by landing on two different arteries, the main artery (in direct continuity with the foot vessels) and the secondary one (perfusing the angiosome district)...

<b/> Background : Peripheral artery disease presents an increasing healthcare burden worldwide. Day-case angioplasty in a secondary care setting can be a safe and effective means of meeting the growing demand for lower limb revascularisation. We evaluated the safety and efficacy of a day-case-based angioplasty service in a UK district general hospital. Patients and methods : Consecutive patients undergoing endovascular revascularisation between August 2018-February 2020 were analysed retrospectively. All patients were discussed at a multi-disciplinary (diabetic foot) team meeting following a day case algorithm...

Ischaemic diabetic heel ulcers are difficult to treat and prognosis is often guarded. The aim was to document our outcome of treating heel ulcers following revascularization in a predominantly diabetic Asian cohort presenting with chronic limb threatening ischaemia from Singapore. Retrospective cohort study (n = 66, 66 limbs) over a 5-year period. Data were collected from hospital electronic health records. Outcomes included time to healing, amputation free survival (AFS), and mortality. Minimum follow-up period was 6 months...

BACKGROUND: Cell therapy was proposed as a procedure of indirect revascularization for patients with critical ischaemia of lower extremities for whom endovascular and surgical revascularization is impossible. We present herein a review of the state of the art of studies in the field of cell therapy of this cohort of patients. BASIC PROVISIONS: Cell therapy has proved safe, however, the results of studies of efficacy are relatively ambiguous and unconvincing. The number of patients in separately taken clinical trials is minimal...

Peripheral arterial disease (PAD) confers an elevated risk of major amputation and delayed wound healing in diabetic patients with foot ulcers. The major international vascular societies recently developed evidence-based guidelines for the assessment and management of patients with chronic limb-threatening ischaemia (CLTI). CLTI represents the cohort of diabetic and non-diabetic patients who have PAD which is of sufficient severity to delay wound healing and increase amputation risk. Diabetic patients with CLTI are more likely to present with tissue loss, infection and have less favourable anatomy for revascularization than those without diabetes...

AIM: To assess the impact of autologous cell therapy on critical limb ischaemia in people with diabetes and diabetic kidney disease. METHODS: A total of 59 people with diabetes (type 1 or type 2) and critical limb ischaemia, persisting after standard revascularization, were treated with cell therapy in our foot clinic over 7 years; this group comprised 17 people with and 42 without severe diabetic kidney disease. The control group had the same inclusion criteria, but was treated conservatively and comprised 21 people with and 23 without severe diabetic kidney disease...

BACKGROUND: Bypass surgery (BS) remains the gold standard revascularization strategy in patients with chronic limb-threatening ischemia (CLTI) owing to infrainguinal disease. The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-1 trial showed that, in patients with CLTI who survived for 2 years or more, BS resulted in better clinical outcomes. Despite this finding, there has been an increasing trend toward an endovascular-first approach to infrainguinal CLTI. Our aim was to investigate whether changes in practice have impacted the clinical outcomes of BS in our unit 10 years after BASIL-1...

BACKGROUND: Chronic limb-threatening ischemia (CLTI), defined as ischemic rest pain or tissue loss secondary to arterial insufficiency, is caused by multilevel arterial disease with frequent, severe infrageniculate disease. The rise in CLTI is in part the result of increasing worldwide prevalence of diabetes, renal insufficiency, and advanced aging of the population. The aim of this study was to compare a bypass-first with an endovascular-first revascularization strategy in patients with CLTI due to infrageniculate arterial disease...

OBJECTIVES: We aimed to assess the outcome of endovascular revascularization in Diabetic patients with Fontaine stage IV chronic ischaemia, at our Diabetic Foot Clinic. Primary outcomes were ulcer healing, major amputation and limb salvage. METHODS: Retrospective single center analysis of patients treated between January 2009 and May 2015. Time-dependent event rates were estimated by the Kaplan-Meier method. The differences between groups were evaluated with the chi-square test...

Diabetic foot ulcers (DFUs) are one of the most common indications for hyperbaric oxygen treatment (HBOT). The role of HBOT in DFUs is often debated. Recent evidence based guidelines, while recommending its use, urge further studies to identify the patient subgroups most likely to benefit from HBOT. A recent study in Diabetes Care aimed to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with chronic DFUs. In this study, patients with Wagner grade 2-4 diabetic foot lesions were randomly assigned to have HBOT (30 sessions/90 min/244 kPa) or sham treatment (30 sessions/90 min/air/125 kPa)...

OBJECTIVES: It is difficult to establish which patients suffering from critical lower limb ischaemia will benefit from revascularization. Risk scores can provide objectivity in decision making. The aim was to design a new risk score (ERICVA) and compare its predictive power with the PREVENT III and Finnvasc scores. METHODS: An observational retrospective study of patients who underwent revascularization (open or endovascular) in Valladolid's University Hospital between 2005 and 2010 was designed...