Outcomes of Chopart Amputation in a Tertiary Referral Diabetic Foot Clinic: Data From a Consecutive Series of 83 Hospitalized Patients.

The purpose of the present retrospective study was to evaluate the outcomes (ie, ulcer recurrence, major amputation, death) in diabetic patients undergoing Chopart amputation because of deep infection or gangrene extending to the midfoot. From 2009 to 2011, 83 patients, aged 71.4 ± 9.3 years, underwent a midtarsal amputation and were followed up until December 31, 2012 (mean follow-up 2.8 ± 0.8 years). Of the 83 patients, 26 were female, 61 required insulin, 47 had renal insufficiency, 19 underwent hemodialysis, 65 had hypertension, 34 had a history of cardiac disease, and 4 had a history of stroke. Chopart amputation was performed in 38 patients (45.8%) with gangrene, 31 (37.4%) with abscess, and 14 (16.9%) with osteomyelitis. Urgent surgery was performed in 56 patients (67.5%). Effective revascularization was performed in 64 patients (77.1%) patients. Of the 83 patients, 47 had healed at a mean period of 164.7 (range 11 to 698) days. Ulcer recurrence developed in 15 patients (31.9%). A major amputation was necessary in 23 patients (27.7%), with an annual incidence of 13.0%. None of the included variables on logistic regression analysis was significantly associated with proximal amputation. Of the 83 patients, 38 (45.8%) died, with an annual incidence of 25.8%. On logistic regression analysis, age (odds ratio [OR] 1.11, 95% confidence interval [CI] 1.01 to 1.16), history of stroke (OR 9.94, 95% CI 3.16 to 31.24), and urgent surgery (OR 2.60, 95% CI 1.14 to 5.93) were associated with mortality. Chopart amputation represents the last chance to avoid major amputation for diabetic patients with serious foot complications. Our success rate was great enough to consider Chopart amputation a viable option for limb salvage in this high-risk population.

Severity of demographic and clinical characteristics, revascularization feasibility, major amputation, and mortality rate in diabetic patients admitted to a tertiary diabetic foot center for critical limb ischemia: comparison of 2 cohorts recruited at a 10-year distance.

BACKGROUND: To compare demographic and clinical characteristics, revascularization, major amputation, and mortality among patients admitted to a diabetic foot center because of critical limb ischemia (CLI) during 1999-2003 (cohort 1) and 2009 (cohort 2). METHODS: During 1999-2003, 564 diabetic patients with CLI (cohort 1) were admitted to our center, and 344 patients (360 affected limbs) were admitted during 2009 (cohort 2). Data on demographic and clinical characteristics, revascularization by peripheral angioplasty (PTA) or bypass graft (BPG), major amputation, and mortality were recorded. RESULTS: Patients belonging to cohort 2 were older than patients of cohort 1 (P = 0.001). In cohort 2, there were more subjects requiring insulin (P = 0.008) and duration of diabetes was longer (P = 0.001); moreover, there were more patients requiring dialysis (P = 0.001), patients with history of stroke (P = 0.004), or foot ulcer (P = 0.001). No significant difference between the 2 groups was found concerning gender, metabolic control, hypertension, lipid values, neuropathy, and retinopathy. Occlusion was more frequent than stenosis in the posterior tibial (P < 0.001) and peroneal (P = 0.016) arteries. However, the revascularization rate did not differ (P = 0.318) between the 2 groups. Restenosis after PTA was not significantly different (P = 0.627), whereas BPG failure was significantly more frequent (P = 0.010) in cohort 2 (2009). Major amputation (P = 0.222) and mortality rate (P = 0.727) did not differ between the 2 groups. CONCLUSIONS: The severity of either foot lesions or patients comorbidities should be concomitantly assessed and taken into proper consideration when evaluating changes in the amputation rate among different studies or in different temporal settings.

Influence of osteomyelitis location in the foot of diabetic patients with transtibial amputation.

BACKGROUND: To evaluate the prevalence of osteomyelitis in different areas of the foot and the possible correlation between localization and outcome of major amputation. METHODS: From January 2008 to December 2010, a total of 350 diabetic patients were admitted to our diabetic foot unit for the surgical treatment of osteomyelitis. Osteomyelitis was diagnosed when both the probe-to-bone maneuver and plain radiography were positive. In all of these patients, osteomyelitis was confirmed by histological examination. RESULTS: Osteomyelitis was localized to the forefoot in 300 (85.7%) patients, to the midfoot in 27 (7.7%) patients, and to the hindfoot in the remaining 23 (6.75) patients. On average, foot lesions had developed 6.6 ± 5.6 months before admission to our unit. Transtibial amputation was performed in 1 (0.33%) patient with forefoot osteomyelitis, in 5 (18.5%) patients with midfoot osteomyelitis, and in 12 (52.2%) patients with osteomyelitis of the heel (χ(2) = 128.4, P < .001). Multivariate analysis showed the independent role that osteomyelitis in the heel region had in major amputation outcome (odds ratio 15.3; P < .001; confidence interval, 17.4-5336.0), dialysis treatment (odds ratio 6.3; P = .012; confidence interval, 2.5-1667.2), and leukocyte count greater than 10(3) mm(3) (odds ratio 2.25; P = .036; confidence interval, 1.1-76.6). CONCLUSIONS: We found a higher rate of transtibial amputation when osteomyelitis involved the heel instead of the midfoot or forefoot in diabetic patients. LEVEL OF EVIDENCE: Level III, retrospective comparative series.

Prognostic difference between soft tissue abscess and osteomyelitis of the foot in patients with diabetes: data from a consecutive series of 452 hospitalized patients.

From January 2008 to December 2010, 452 patients with diabetes were admitted to our diabetic foot unit because of deep soft tissue abscess (group A: n = 210) or chronic osteomyelitis (group B: n = 242). Patients from group A underwent emergency debridement in the operating room. Patients from group B underwent elective surgery. Twenty-six (5.8%) major amputations were performed: of these, 18 (8.57%) were performed in patients from group A and 8 (3.31%) were performed in patients from group B (p = .024). Multivariate analysis showed the independent role on amputation outcome of the abscess (odds ratio, 2.64; p = .029; confidence interval [CI] 1.11 to 6.28), dialysis treatment (odds ratio, 3.17; p = .039, CI 1.06-9.51), and C-reactive protein > 0.5 mg/dL (odds ratio, 3.75; p = .022, CI 1.21-11.64). In group A, 43 (22.6%) patients healed only with drainage, and 147 (70.0%) minor amputations were performed: 53 (36.1%) at the level of the forefoot and 94 (63.9%) at the level of the midfoot. In group B, 234 (96.7%) minor amputations were performed, 208 (88.9%) at the forefoot and 26 (11.1%) at the midfoot level (p < .001). Fourteen postoperative complications occurred in patients from group A and 2 in patients from group B (p < .001). In group A, 3 patients died during hospitalization, 1 from septic shock and 2 from sudden death. None of the group B patients died. This study demonstrates that the severity of a foot soft tissue abscess is not comparable with that of a chronic osteomyelitis not only because of a higher rate of major amputation, but also because of a much more proximal level of minor amputation.

Feasibility and effectiveness of internal pedal amputation of phalanx or metatarsal head in diabetic patients with forefoot osteomyelitis.

From January 2007 to December 2009, 207 diabetic patients were consecutively admitted to our foot center because of osteomyelitis of a phalanx or metatarsal head. The removal of infected bone was performed by internal bone resection in 110 patients (group A) and amputation in 97 patients (46.9%; group B). Dehiscence occurred in 15 patients (13.6%) patients in group A and 10 patients (10.3%) in group B (p = 0.464). A total of 206 patients (99.5%) were followed up from January 1, 2007 to December 31, 2011. Ulcer relapse occurred in 12 patients (12.4%) in group A and 18 patients (16.4%) in group B (p = .437). A contralateral ulcer occurred in 10 group A patients (10.3%) and 14 group B patients (12.7%; p = .667). The results of the present study have demonstrated that bone resection with preservation of the soft tissue envelope is feasible in approximately one half of diabetic patients with forefoot osteomyelitis and does not result in any risk of major dehiscence or ulcer recurrence compared with ray or toe amputation.

Photodynamic Topical Antimicrobial Therapy for Infected Diabetic Foot Ulcers in Patients With Diabetes: A Case Series.

Diabetic foot ulcers (DFUs) are common, complex, costly complications, associated with frequent recurrences and increased morbidity and mortality. DFUs can be prevented and their healing can be mostly influenced by appropriately and aggressively managing any infection, but the role of antiseptic therapies in reducing healing time lacks sufficient evidence. Several therapeutic interventions have been developed based on the principles of photomedicine to overcome the issue of poor drug circulation in infected areas, with the aim of killing microbial agents while leaving the surrounding host cells unharmed. Such techniques use absorption of photons by specific chromophores. Among these, RLP068 is a tetracationic Zn(II) phthalocyanine derivative activated by exposure to red light, used as a topical treatment for superficial bacterial and fungal infections. The photoactivation of RLP068 results in the production of singlet oxygen and other reactive oxygen species, able to affect a range of cellular targets, including cell membrane and/or wall, cytoplasm, and cellular components, resulting in a rapid, broad range, bactericidal and fungicidal effect. The phase IIa study showed that photoactivated RPL068 is capable of inducing a dose-dependent reduction in total and pathogen microbial load in infected diabetic foot ulcers. In this article, a case series of 22 DFU treated with photoactivated RLP068 at 5 different centers in Italy is presented. Considering microbial agents reduction, ulcer healing facilitation, healing rate (9 DFUs out of 22), and amputation rate (only 1 case over 22), the decrease in the cost of DFU seems to be a point in favor of RLP068 and its cost-effectiveness.

New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System.

OBJECTIVE: To perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile. DESIGN: An early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone. SETTING: The Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen. PARTICIPANTS: Hypothetical patients with diabetic foot infection (DFI) grades I/IIB. INTERVENTIONS: The PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs. MAIN OUTCOMES: Days within which the clinical target was achieved and direct health costs for patients' management. RESULTS: Additional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7-28 days, ICERs varied from about 1€ to 70€ for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7-28 days, BI was 8,100,000€ to 700,000€, with saving less than 2,000,000€ with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process. CONCLUSION: The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system.

The use of a dermal substitute to preserve maximal foot length in diabetic foot wounds with tendon and bone exposure following urgent surgical debridement for acute infection.

In this study, we evaluated the utility of a dermal substitute for preserving maximal foot length after urgent surgical debridement. Patients referred to our Diabetic Foot Center with foot lesions were assessed for sensory-motor neuropathy, infection and critical limb ischaemia. The presence of acute foot infection indicated the need for immediate surgical debridement. The degree of amputation, if necessary, was based on the amount of apparently non infected vital tissue. When vital tendon/bone tissue remained exposed, the lesion was covered with a dermal substitute. From January to December 2008, 393 patients underwent surgical treatment for diabetic foot syndrome; 30 patients underwent immediate surgical debridement resulting in exposed tendon and/or bone tissues. An average of 4.4 +/- 2.1 days following surgical debridement, all 30 patients underwent dermal regeneration template grafting to cover-exposed healthy tendon and bone tissues, instead of achieving primary wound closure with a proximal amputation. After 21 days, a skin graft was performed. Complete wound healing occurred in 26 patients (86.7%). In these patients, the amputation level was significantly more distal (P < 0.003) with respect to that potentially required for immediate wound closure. The average healing time was 74.1 +/- 28.9 days. Four patients underwent a more proximal amputation. No patients underwent major amputation. The use of the dermal substitute for treating exposed tendon and bone tissues allowed timely wound healing and preserved maximal foot length. Continued follow-up will allow assessment of long-term relapse and complication rates. Such treatment could constitute part of the comprehensive management of diabetic wounds.

The benefits of antimicrobial photodynamic therapy with RLP068 in the management of diabetic foot ulcers.

This article is the first part of a literature review concerning diabetic foot ulcers and the use of antimicrobial photodynamic therapy (PDT). Diabetic foot ulcers are associated with high morbidity, mortality, and healthcare costs. Natural healing is often delayed by microbial infection or colonisation, which might lead to serious complications, such as amputation. Furthermore, antibiotic treatment could have limited success because of the development of bacterial resistance and severely limited drug delivery to the ulcer due to vascular damage. PDT has antimicrobial effects and has been used to reduce the total and pathogenic microbial load in diabetic ulcers without inducing bacterial resistance. It is safe and can be used to improve outcomes. A clinical trial demonstrated that PDT with RLP068 reduced the microbial load of diabetic ulcers in 62 patients. This article reports previously published evidence and presents four, unpublished, clinical cases treated in the real-life setting.

Incidence of critical limb ischemia and amputation outcome in contralateral limb in diabetic patients hospitalized for unilateral critical limb ischemia during 1999-2003 and followed-up until 2005.

We studied the incidence of critical limb ischemia (CLI) and amputation outcome of the contralateral limb in 533 diabetic patients hospitalized in our diabetic foot centre because of CLI from 1999 to 2003 and followed-up until 2005. The cumulative incidence rate during the 6-year period reached 49.8% (CI confidence interval=40.6-59.6). All patients underwent arteriography and in 181 (98.4%) the revascularization was performed without different feasibility (p=0.077) compared to that (95.3%) in the initial patients. The severity of lesion evaluated with Wagner grade was lower (chi(2)=33.5, p<0.001) and also the frequency of midfoot and above-the-ankle amputations was lower (p<0.001 and p=0.022, respectively) in contralateral patients. There was no evidence from the logistic analysis to support the association between any of the investigated variables and incidence of CLI in the contralateral limb. Over a 6-year period, almost 50% of the diabetic patients with unilateral CLI developed a CLI in the contralateral limb: however, both severity of foot lesion and amputation level was significantly lower. This fact can be due to prompt therapeutic interventions, made possible thanks to an increased patient awareness acquired by training during the treatment of the unilateral limb.

Effectiveness of combined therapy with angiotensin-converting enzyme inhibitors and statins in reducing mortality in diabetic patients with critical limb ischemia: an observational study.

AIMS: To investigate the effect of combined treatment with angiotensin-converting enzyme inhibitors (ACE) and statins on mortality in diabetic patients with critical limb ischemia (CLI). METHODS: Prospective observational study of 553 consecutive diabetic patients admitted because of CLI followed for a mean of 2.2 years. All patients underwent peripheral revascularization and antithrombotic therapy was prescribed or continued and therapy with statin and ACE was recorded. Mortality from any cause was assessed and Kaplan-Meier analyses were performed to compare the relationship between survival and recorded variables. RESULTS: One hundred thirty-nine patients did not have therapy with statin or an ACE, 78 had therapy with statin without ACE, 164 had therapy with ACE without statin and 172 patients had therapy with both statin and ACE. One hundred thirty-six patients died, 45/139 with neither statin nor ACE, 40/164 with ACE only, 26/78 with statin only, and 25/172 with both statin and ACE. Multivariate analysis confirmed the independent role of age, history of stroke, renal insufficiency and dialysis. Combined treatment with ACE and statin appeared to have a protective role. CONCLUSIONS: In patients with diabetes and CLI mortality after two years is high. Life expectancy was better in patients receiving combined therapy with ACE and statin but not with therapy with only a statin or an ACE.

Revascularization by angioplasty of type D femoropopliteal and long infrapopliteal lesion in diabetic patients with critical limb ischemia: are TASC II recommendations suitable? A population-based cohort study.

Feasibility of revascularization of type D femoropopliteal and long infrapopliteal lesions by angioplasty (peripheral translumenal angioplasty [PTA]) in diabetic patients with critical limb ischemia (CLI) according to the TransAtlantic Inter-Society Consensus (TASC) II recommendations was studied. A total of 292 diabetic patients were admitted for CLI; 308 limbs underwent a PTA. Out of 211 femoropopliteal lesions treated with PTA, 44 were TASC II type A, 45 type B, 48 type C, and 76 type D lesions. In 44 of the 76 patients with type D lesions revascularized by PTA, no artery was patent down to the foot before the PTA. In 172 limbs with all infrapopliteal arteries occluded, revascularization was carried out down to the foot in 167 limbs. Follow-up was 3.1 ± 0.3 years. A first episode of restenosis occurred in 66/308 limbs with an incidence/year of 7.9. PTA procedures were successfully repeated in 57/66 restenosis episodes: secondary patency was 97.1%. The incidence/year of type D femoropopliteal lesions was 5.4, the incidence/year in others was 5.0, without statistically significant differences: P = .417. The only variable found significantly associated with restenosis occurrence on logistic analysis was the presence of lesions in both femoropopliteal and infrapopliteal axes. A total of 26/308 above-the-ankle amputations were performed, with an incidence/year of 2.5. Multivariate analysis showed the independent role of only crural artery occlusion after PTA. These data show that the choice to refer to angioplasty diabetic patients with type D and/or long infrapopliteal lesions without good run-off at the foot and/or high surgical risk allowed high revascularization feasibility, with an optimal amputation outcome.

Mortality after major amputation in diabetic patients with critical limb ischemia who did and did not undergo previous peripheral revascularization Data of a cohort study of 564 consecutive diabetic patients.

BACKGROUND: To evaluate the survival after major lower limb amputation, at a level either below (BKA) or above (AKA) the knee, in diabetic patients admitted to hospital because of critical limb ischemia (CLI). METHODS: From January 1999 to December 2003, 564 diabetic patients were consecutively admitted to our Foot Center because of CLI and followed up until December 2005. A revascularization procedure was performed in 537 patients (95.2%): in 420 with peripheral angioplasty, in 117 with peripheral bypass graft. Neither endoluminal nor surgical revascularization was practicable in 27 (4.8%) patients. RESULTS: Major amputation was performed in a total of 55 (9.8%) patients. Among the clinical and demographic variables evaluated, age was significantly lower (67.3+/-10.1 vs. 76.7+/-10.4, P<.001), duration of diabetes was higher (17.1+/-11.1 vs. 13.4+/-10.0, P=.013), and current smoking was more frequent (38.5% vs. 25.0%, P<.001) in revascularized amputees. The amputation free median time for revascularized patients was 5.11 months, and for nonrevascularized patients, 0.33 months. The log-rank test for equality of survivor function without amputation between amputees with or without revascularization was 31.76 (P<.001). Among the 55 amputees, 11 (28.2%) out of the 39 revascularized patients and 13 (81.2%) out of the 16 nonrevascularized patients died. The log-rank test for equality of survivor function was 6.83 (P=.009). The Cox model performed to evaluate the association between the recorded variables and the mortality showed a significant hazard ratio only with age (hazard ratio for 1 year 1.11, P=.003, confidence interval 1.04-1.19). CONCLUSIONS: Our data suggest that the revascularization allows to postpone the major amputation, and that the survival of revascularized amputees is better than that of nonrevascularized amputated patients. All these data offer further encouragement to revascularize all diabetic patients with CLI.

Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of a removable cast walker compared with that of a nonremovable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer. RESEARCH DESIGN AND METHODS: Forty-five adult diabetic patients with nonischemic, noninfected neuropathic plantar ulcer were randomly assigned for treatment with a nonremovable fiberglass off-bearing cast (total contact cast [TCC] group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment. RESULTS: A total of 48 patients were screened; however, 2 patients in the TCC group and 1 patient in the Stabil-D group did not complete the study and were considered dropouts. There were no significant differences in demographic and clinic characteristics of the 45 patients completing the study. Ulcer surface decreased from 1.41 to 0.21 cm(2) (P < 0.001) in the TCC group and from 2.18 to 0.45 cm(2) (P < 0.001) in the Stabil-D group, with no significant differences between groups (P = 0.722). Seventeen patients (73.9%) in the TCC group and 16 patients (72.7%) in the Stabil-D group achieved healing (P = 0.794). Average healing time was 35.3 +/- 3.1 and 39.7 +/- 4.2 days in the TCC and Stabil-D group, respectively (P = 0.708). CONCLUSIONS: The Stabil-D cast walker, although removable, was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate. The easier use of Stabil-D may help increase the use of off-loading devices in the management of plantar neuropathic diabetic foot ulcers.

Evaluation of feasibility of ankle pressure and foot oximetry values for the detection of critical limb ischemia in diabetic patients.

A total of 261 diabetic patients were admitted because of rest pain and/or foot ulcer in 1 limb. Ankle pressure (AP) and transcutaneous oxygen tension (TcPO(2)) were measured, and digital subtraction arteriography was performed. Transcutaneous oxygen tension was <30 mm Hg in 213 patients and >or=30<50 mm Hg in 48 patients. Ankle pressure could not be measured in 109 patients. In 50 patients, AP was <70 mm Hg and in 102 patients, it was >or=70 mm Hg. Arteriography showed evidence of stenoses >50% of vessel lumen diameter in all patients. Major amputation was performed in 16 patients; AP was <70 mm Hg in 4 patients and >or=70 mm Hg in 6. It was not practicable in the remaining 6 patients. Transcutaneous oxygen tension was <30 mm Hg in 15 patients and >or=30 mm Hg in 1 patient. For diagnosis of critical limb ischemia (CLI) in diabetic patients presenting with rest pain or foot ulcer, measurement of TcPO( 2) is essential not only when AP is not measurable but also when this value is >or=70 mm Hg.

The use of a dermal substitute (integra) to preserve maximal foot length in a diabetic foot wound with bone and tendon exposure following urgent surgical debridement for an acute infection.

In this report, the authors present the case of a 62-year-old female patient who was admitted to our hospital with an acute deep foot infection. The patient was taken immediately to the operating room where she underwent surgical debridement to completely remove all infected tissues; at the end of this first surgical step, all 5 metatarsal bones remained exposed dorsally. Once eradication of infection was completed, we had to decide whether to perform a transmetatarsal amputation at proximal levels, which would have allowed healing by first intention but would have left the patient with a smaller foot stump, or amputation at more distal levels followed by coverage of healthy tendon and bone tissues with a dermal regeneration template (Integra, Integra Life Sciences Corporation, Plainsboro, NJ), which would have preserved the foot stump length and allowed better walking. We opted for the second choice, and the use of a dermal template actually enabled our patient to maintain a considerable foot stump length, much longer than would have resulted from an amputation with immediate primary closure.

Long-term prognosis of diabetic patients with critical limb ischemia: a population-based cohort study.

OBJECTIVE: To evaluate the long-term prognosis of critical limb ischemia (CLI) in diabetic patients. RESEARCH DESIGN AND METHODS: A total of 564 consecutive diabetic patients were hospitalized for CLI from January 1999 to December 2003; 554 were followed until December 2007. RESULTS: The mean follow-up was 5.93 +/- 1.28 years. Peripheral angioplasty (PTA) was performed in 420 (74.5%) and bypass graft (BPG) in 117 (20.6%) patients. Neither PTA nor BPG were possible in 27 (4.9%) patients. Major amputations were performed in 74 (13.4%) patients: 34 (8.2%) in PTA, 24 (21.1%) in BPG, and 16 (59.2%) in a group that received no revascularization. Restenosis occurred in 94 patients, bypass failures in 36 patients, and recurrent ulcers in 71 patients. CLI was observed in the contralateral limb of 225 (39.9%) patients; of these, 15 (6.7%) required major amputations (rate in contralateral compared with initial limb, P = 0.007). At total of 276 (49.82%) patients died. The Cox model showed significant hazard ratios (HRs) for mortality with age (1.05 for 1 year [95% CI 1.03-1.07]), unfeasible revascularization (3.06 [1.40-6.70]), dialysis (3.00 [1.63-5.53]), cardiac disease history (1.37 [1.05-1.79]), and impaired ejection fraction (1.08 for 1% point [1.05-1.09]). CONCLUSIONS: Diabetic patients with CLI have high risks of amputation and death. In a dedicated diabetic foot center, the major amputation, ulcer recurrence, and major contralateral limb amputation rates were low. Coronary artery disease (CAD) is the leading cause of death, and in patients with CAD history the impaired ejection fraction is the major independent prognostic factor.

Advantages of myocardial revascularization after admission for critical limb ischemia in diabetic patients with coronary artery disease: data of a cohort of 564 consecutive patients.

AIM: To evaluate the survival benefit from myocardial revascularization in diabetic patients with critical limb ischemia and coronary artery disease (CAD) in a consecutive series of 564 diabetic patients hospitalized from 1999 to 2003 and followed up until December 2005. METHODS: Three hundred and thirteen patients had a history of CAD, 60 of them (19.2%) with previous myocardial revascularization. Sixty-one patients with an ejection fraction of 40% or less underwent subsequent myocardial revascularization. Five hundred and fifty-seven patients (98.8%) were followed up until December 2005, including 310 of the 313 patients with a history of CAD. RESULTS: One hundred and ten patients died because of CAD, 25 of the 251 patients without a history of CAD and 85 of the 313 patients with a history of CAD. Specifically, 74 (86.9%) of these 85 deaths occurred in the 192 patients without previous myocardial revascularization, nine (10.7%) in the 60 patients with previous myocardial revascularization, and two (2.4%) in the 61 patients in whom myocardial revascularization was performed after hospital admission for critical limb ischemia. The Cox model showed significant hazard ratio for mortality associated with age [hazard ratio 1.06 for 1 year, P = 0.003, confidence interval (CI) 1.02-1.09], history of CAD (hazard ratio 2.16, P < 0.001, CI 1.53-3.06), dialysis (hazard ratio 3.52, P < 0.001, CI 2.08-5.97), and impaired ejection fraction (hazard ratio 1.08 for one point percentage, P < 0.001, CI 1.05-1.09). Myocardial revascularization appeared to have a protective role: hazard ratio 0.29, P < 0.001, CI 0.33-0.93. CONCLUSION: Paying attention to CAD in diabetic patients during their hospitalization for critical limb ischemia is useful for a subsequent myocardial revascularization, and it may increase survival in these patients.