Renin-Angiotensin-Aldosterone System Inhibitors, Statins, and Beta-Blockers in Diabetic Patients With Critical Limb Ischemia and Foot Lesions.

Medical therapy for secondary prevention is known to be under-used in patients with peripheral artery disease (PAD). Few data are available on the subgroup with critical limb ischemia (CLI). Prescription of cardiovascular preventive therapies was recorded at discharge in a large, prospective cohort of patients admitted for treatment of CLI and foot lesions, stratified for coronary artery disease (CAD) diagnosis. All patients were followed up for at least 1 year. The primary endpoint was major adverse cardiovascular events (MACE). 618 patients were observed for a median follow-up of 981 days. Renin-angiotensin-aldosterone system (RAAS) inhibitors, statins, beta-blockers, and antithrombotic drugs were prescribed in 52%, 80%, 51%, and 99% of patients, respectively. However, only 43% of patients received optimal medical therapy (OMT), defined as the combination of RAAS inhibitor plus statin plus at least one antithrombotic drug. It was observed that the prescription of OMT was not affected by the presence of a CAD diagnosis. On the other hand, it was noticed that the renal function affected the prescription of OMT. OMT was independently associated with MACE (HR 0.688, 95%CI 0.475-0.995, P = .047) and, after propensity matching, also with all-cause mortality (HR 0.626, 95%CI 0.409-0.958, P = .031). Beta-blockers prescription was not associated with any outcome. In conclusion, patients with critical limb ischemia are under-treated with cardiovascular preventive therapies, irrespective of a CAD diagnosis. This has consequences on their prognosis.

High-Sensitivity Cardiac Troponin Predicts Major Cardiovascular Events in Diabetic Patients With Critical Limb Ischemia and Foot Lesions.

Background: Diabetic patients with critical limb ischemia (CLI) and foot lesions show a poor prognosis. Optimal risk stratification to guide tailored intervention is still uncertain. The aim of the present study was to assess the prognostic role of high-sensitivity cardiac troponin T (hs-TnT) in such a high-risk population. Methods and Results: Clinical, laboratory, and interventional data, as well as the SPINACH score, were collected. Hs-TnT was measured at hospital admission. All patients were followed up for at least 1 year. The primary endpoint was the cumulative occurrence of major cardiovascular events (MACEs, all-cause death, myocardial infarction, or stroke). The secondary endpoint was all-cause mortality. Overall, 618 patients were included and followed for a median of 981 (557-1,325) days. Diagnosis of coronary artery disease (CAD) was established in 270 (43.7%) patients. Median hs-TnT at admission was 31 (20-59) ng/L, with 525 (85%) patients over the upper reference limit. Hs-TnT values were significantly higher in patients with established CAD (39 vs. 29 ng/L, p < 0.01). Hs-TnT was an independent predictor of MACE (HR 2.440, 95% CI 1.706-3.489, p < 0.001). The best cut-offs were 40 ng/L (AUC 0.711) for patients with established CAD and 25 ng/L (AUC 0.725) for those without. Hs-TnT emerged also as an independent predictor of all-cause mortality. The addition of hs-TnT improved prognostic value of the SPINACH score. Conclusions: Hs-TnT is a powerful biomarker for prognostic stratification of diabetic CLI patients with foot lesions. This is confirmed independently to CAD diagnosis and permits the identification of higher risk patients requiring tailored intervention.

Surgical OFF-LOADING of the diabetic foot.

Diabetic foot ulcer treatment is a challenge for the healthcare world. Widespread infection and the presence of critical ischemia (especially with end-stage renal disease) can lead to major amputation rather than amenable to conservative treatment. Surgical strategies of the diabetic foot have been changing over the past 10 years and are now focused on reconstructive treatment and limb salvage. These goals were achieved, thanks to an evolution of distal revascularization techniques and a distinct approach, which integrates various methods focused on limb salvage. Podoplastic techniques of the diabetic foot are focused on infection clearance, the surgical treatment of corrective deformities, soft tissue coverage and limb ischemia correction along with the management of diabetes and the comorbidities that compromise tissue repair processes. The reconstructive techniques used in diabetic foot treatment owe their effectiveness in part to the results of technological improvements such as the circular external fixator as a tool for stabilization and surgical site protection. In the last decade, many studies have shown that circular external fixation should be considered as the most useful method to protect the reconstructive surgical site in limb salvage of the diabetic foot. The objective of this review is to highlight the role of surgical offloading using circular external fixation as an adjunct to the podoplastic diabetic foot reconstruction procedures.

Use of Integra Dermal Regeneration Template for Limb Salvage in Diabetic Patients With No-Option Critical Limb Ischemia.

We have analyzed in a retrospective study of consecutive diabetic patients affected by no-option critical limb ischemia (CLI) the efficacy of the dermal substitute Integra Dermal Regeneration Template for treatment of complicated foot lesions. The primary end point was limb salvage and 1-year amputation-free survival. The secondary end point was healing time of surgical site. Between October 2014 and October 2017, 1024 patients with diabetic foot ulcer (DFU) and CLI were admitted. In 84 patients (8.2%), there was a failure in distal revascularization with a persistent CLI after the procedure. Despite the persistent CLI, a group of 26 patients of this cohort obtained complete wound healing. Among them, 13 patients were treated with surgical debridement or open amputations and application of dermal substitute Integra Dermal Regeneration Template and the other 13 patients were treated without any dermal substitute. The Integra group healed within a mean time of 83.5 days, and the control group healed within a mean of 139 days (P = .028). No major amputation was carried out at 1-year follow-up in the Integra group versus 15% in the control group. A conservative foot surgery or an approach with minor amputation in diabetic patients with no-option CLI may achieve limb salvage. The use of Integra Dermal Regeneration Template in patients with DFU and no-option CLI may be a useful option in a limb salvage program.

Limb salvage in diabetic patients with no-option critical limb ischemia: outcomes of a specialized center experience.

Objective: To describe the characteristics, the management and the outcome of a consecutive series of patients with diabetic foot lesions (DF) and no-option critical limb ischemia (CLI) treated with a multidimensional, interdisciplinary approach in a dedicated center. Research Design and Methods: The prospective database of the Diabetic Foot Unit of the Maria Cecilia Hospital (Cotignola, Italy) collects medical history, risk factors, chemistry values, angiographic data, characteristic of foot lesions, medical and surgical therapies of all patients admitted with a diagnosis of DF and CLI. All patients were followed-up for at least 1 year and/or total recovery. The primary endpoint was 1-year amputation-free survival (AFS), secondary endpoints were limb salvage and survival. Results: Between October 2014 and October 2017, 1024 patients with DF and CLI were admitted to the center. Eighty-four of them (8.2%) fulfilled the criteria for no-option CLI. At 1 year, AFS, limb salvage, and survival rates were 34%, 34%, and 83%, respectively. Lesions located proximal to the Lisfranc joint were associated with major amputation (HR 2.1 [1.2-3.6]). One-year survival of patients treated with minor procedures was significantly higher compared to patients treated with major amputation (96% vs 76%, log-rank p = 0.019). Major amputation was independently associated with mortality (HR 7.83 [1.02-59.89]). Conclusions: The application of dedicated and standardized strategies permitted limb salvage in one-third of patients with no-option CLI. Patients with stable lesions limited to the forefoot and without ischaemic pain had a greater probability to successfully receive conservative treatments. Limb salvage was associated with subsequent higher one-year survival.

Combination of Open Subtotal Calcanectomy and Stabilization With External Fixation as Limb Salvage Procedure in Hindfoot-Infected Diabetic Foot Ulcers.

Diabetic hindfoot ulcers, complicated by osteomyelitis, are associated with a high risk of major amputation. Partial calcanectomy, preceded by an effective management of the infection and of the eventual peripheral artery disease, can be considered as valid therapeutic option. We have evaluated a therapeutic protocol for diabetic hindfoot ulcers complicated by osteomyelitis, which, besides an adequate surgical debridement, considers a reconstructive pathway assisted by the positioning of a circular external fixator. We made a prospective study of a cohort of diabetic patients affected by heel ulcer complicated by osteomyelitis. All patients underwent open partial calcanectomy associated with the positioning of a circular external frame specifically designed for hindfoot stabilization and offloading. A reconstructive procedure was implemented starting with the application of negative pressure wound therapy and coverage with dermal substitute and split thickness skin grafting. From November 2014 to November 2015, 18 consecutive patients were enrolled. Mean follow-up period was 212.3 ± 64.0 days. Healing was achieved in 18 (100%) patients. The mean healing time was 69.0 ± 64.0 days. No major amputation had to be performed during the follow-up. Open partial calcanectomy associated with external fixation and skin reconstruction was as efficient as limb salvage in patients with infected lesions of the hindfoot complicated by calcaneal osteomyelitis.

Extension and grading of osteomyelitis are not related to limb salvage in Charcot neuropathic osteoarthropathy: A cohort prospective study.

AIMS: Charcot neuropathic osteoarthropathy (CN) represents a complication for diabetic patients which involves a progressive alteration of the osteoarticular apparatus with high risk of amputation. The aim of the study was to assess whether the localization of CN and the extent or grading of the osteomyelitis have an influence on the rate of limb salvage and the time to recovery. METHODS: We treated a diabetic population affected by CN complicated by ulceration and widespread osteomyelitic involvement. All patients were treated surgically to eliminate infected tissues, stabilize and correct the bone deformities. Histopathological and microbiological analyses were carried out on the bone specimens. RESULTS: Thirty-three patients affected by CN complicated by large osteomyelitic involvement of midfoot and/or ankle were treated between January 2010 and May 2014. The mean follow-up was 409,35 ± 154,06 days. Thirty patients had complete recovery (90.91%) at the end of follow-up. No difference in limb salvage rate and time to recovery was observed when stratifying the population according to CN localization, extent and grading of osteomyelitis. CONCLUSIONS: In this cohort prospective study we observed a high percentage of limb salvage in patients affected by CN complicated by diffuse midfoot/hindfoot osteomyelitis. The localization of Charcot deformity and the extent/stage of osteomyelitis did not change the rate of limb salvage.

Conservative Surgical Treatment of Infected Ulceration of the First Metatarsophalangeal Joint With Osteomyelitis in Diabetic Patients.

Ulceration of the plantar aspect of the first metatarsophalangeal joint is a common localization in the diabetic foot. Conservative treatment of this lesion is a challenging problem, performed through the soft tissues and osseous debridement. The present study included a cohort of 28 patients affected by diabetes mellitus and a first ray lesion penetrating the bone. After surgical debridement with removal of the infected bone, we positioned antibiotic-loaded bone cement and stabilized the treated area with an external fixator. All patients with critical limb ischemia had their vascular disease treated before the procedure. The mean follow-up was 12.2 ± 6.9 months. Four patients developed a relapse of the ulceration after the procedure. In the postoperative period, 1 patient (3.57%) developed dehiscence of the surgical site and underwent a second procedure. In the follow-up period, 2 patients (7.14%) experienced bone cement dislocation. In 1 of these patients, a new ulceration was observed dorsally to the surgical site. The approach was surgical revision with bone cement replacement and stabilization with a new external fixator. In the other patient, given the absence of ulcerations, the cement was removed, and arthrodesis with internal stabilization using 2 cannulated screws was performed. One patient (3.57%), who had developed a relapse of ulceration after recurrent critical ischemia, underwent a percutaneous revascularization procedure and transmetatarsal amputation. During the follow-up period, no ulceration recurrences, transfer ulcerations, shoe fit problems, or gait abnormalities were detected in the other 24 patients. Our study presents the results of a technique requiring a 1-stage surgical approach to a relatively common problem, which is often difficult to solve.