Nitinol stents with polymer-free paclitaxel coating for stenosis of failing infrainguinal bypass grafts.

AIM: This study was designed to investigate the immediate and one-year outcomes of polymer-free paclitaxel coated drug-eluting stent (DES) implantation in a consecutive series of patients presenting with stenosis of infrainguinal bypass grafts. METHODS: Between January 2011 and January 2012, 11 patients with failing infrainguinal bypass grafts were treated in two institutions. Clinical status and Duplex scan parameters were recorded at baseline and over a follow-up period of one year. RESULTS: DES implantation was successfully performed in all patients. Ten patients received a single stent and one patient received two stents. At one year, one patient showed total bypass graft occlusion (9%). In all the remaining patients, Duplex scan examination documented patency of the treated grafts. CONCLUSION: DES implantation in failing infrainguinal bypass grafts can be safely performed and provides satisfactory clinical outcomes. The patency rate of 91% favourably compares with those obtained with other endovascular treatments such as plain balloon or cutting balloon angioplasty.

Bailout directional atherectomy for side branch salvage following subintimal recanalization of infragenicular arteries.

A 64-year old diabetic male presenting with critical limb ischemia was treated with percutaneous angioplasty for occlusion of the infragenicular popliteal artery and crural vessels. Directional atherectomy was uncommonly used in the false lumen created by following subintimal angioplasty of the infrapopliteal vessels for re-access into the true lumen. The positive clinical and angiographic results indicate that atherectomy can be considered a useful tool for rescue interventions to reopen large side branches unintentionally occluded during subintimal angioplasty.

Kaposi's sarcoma misdiagnosed as a diabetic plantar foot ulcer.

In this report, the authors describe the case of a patient with Kaposi's sarcoma that was initially misdiagnosed as a plantar ulcer. The ulcer typically appeared as a neuropathic foot ulceration located on the plantar aspect of the first metatarsal head. There was hyperkeratosis on the plantar surfaces of the other metatarsal heads. However, the lesion had mushrooming granulation tissue, without undermined perilesional edges. A wound biopsy revealed the presence of Kaposi's sarcoma. The presence of cancerous lesions on the plantar aspect of the foot is an infrequent event in diabetic patients. However, given the malignant nature of some skin cancers careful clinical examination and biopsy of the wound are advisable.

Angioplasty for diabetic patients with failing bypass graft or residual critical ischemia after bypass graft.

OBJECTIVE: To evaluate the efficacy of peripheral angioplasty (PTA) in the treatment of diabetic patients with previous peripheral bypass graft and recurrent critical limb ischemia (CLI). METHODS: Between January and December 2006, 293 diabetic patients presenting with critical limb ischemia (CLI) according to the TASC 2000 criteria were admitted to our footcare centre. Among these patients, 32 of them had previously undergone bypass grafting: femoropopliteal in 26 patients, femoroposterior tibial in 3 patients, femoroperoneal in the remaining 3. All these patients underwent angiography and, whenever possible, a concomitant PTA procedure. RESULTS: Six patients presented with stenosis at the distal anastomosis, 2 with stenosis at the proximal anastomosis and in 5 patients both the distal and proximal anastomosis were stenosed. In 12 patients the graft was completely occluded. In 7 patients the graft appeared patent but all the infrapopliteal arteries were occluded. The average time interval between bypass and subsequent hospital admission because of CLI was 6.3+/-4.2 months for patients with patent grafts and 20.5+/-12.0 months for those with failing grafts (p=0.004). A successful PTA was performed in 25 patients (78.1%). In all patients with patent grafts, PTA recanalized one infrapopliteal artery. Recanalization of the graft was obtained in all 13 patients with non-occluded graft. Recanalization of superficial femoral artery occlusion by means of PTA was obtained in 5 out of the 12 patients in whom the graft was completely occluded. Five patients underwent major amputation within 30 days and 3 further patients during the follow-up period. Patients were followed up until December 31 2007, with a mean follow-up of 1.89+/-0.27 years. Restenosis occurred in 7 (28.0%) of the 25 patients in whom a successful PTA was performed. In 5 of these 7 patients, PTA was repeated successfully. In 2 patients in whom a further PTA was not feasible a major amputation was performed. At the end of the follow-up period the cumulative primary patency rate was 72%, the assisted patency rate was 92%. CONCLUSIONS: PTA is an effective method for revascularizing secondary obstructions in patients with graft failure (and no possibility of a redo graft). PTA also is effective in at least one subgenicular artery in patients with diabetes with inadequate run-off after femoropopliteal bypass grafting.

When is a technically successful peripheral angioplasty effective in preventing above-the-ankle amputation in diabetic patients with critical limb ischaemia?

AIM: To determine parameters predictive of avoidance of major (above-the-ankle) amputation after a technically successful peripheral angioplasty (PTA) in patients with diabetes with critical limb ischaemia. METHODS: From January 1999 to December 2003, 420 consecutive patients with diabetes admitted to hospital because of critical limb ischaemia underwent peripheral angiography and concomitant technically successful PTA. Transcutaneous oxygen tension (TcPO(2)) was measured before and after PTA. Major amputation at 30 days was recorded. RESULTS: After PTA, the iliac-femoral-popliteal axis was patent in all patients. In 67 patients, all three crural arteries were patent, in 143 patients 2 crural arteries were patent, and in 186 patients one crural artery was patent (104 peroneal, 62 anterior tibial, 20 posterior tibial). In 24 patients, all three crural arteries were occluded. Twenty-two major amputations were performed. Of these, 15 were performed in the 24 patients with occlusion of all the infrapopliteal arteries. Seven of the 186 patients in whom only the peroneal artery was patent required amputation. In patients not requiring amputation, TcPO(2) increased from 15.5 +/- 11.9 to 45.0 +/- 12.0 mmHg (P = 0.000), while in those requiring amputation, TcPO(2) increased from 9.6 +/- 7.7 to 18.6 +/- 8.1 mmHg (P < 0.082). Multivariate analysis indicated an independent role of occlusion of infrapopliteal arteries after PTA (OR 8.20 for every crural obstructed artery, P = 0.022, CI 1.35-49.6) and TcPO(2) after PTA (OR 0.80 for increase of 1 mmHg, P < 0.001, CI 0.74-0.88). CONCLUSIONS: In patients with diabetes, PTA is effective in avoiding major amputation, provided recanalization occurs in at least one tibial artery down to the foot. In a few patients, re-canalization of the peroneal artery alone is not sufficient to avoid major amputation.

Predictive values of transcutaneous oxygen tension for above-the-ankle amputation in diabetic patients with critical limb ischemia.

OBJECTIVE: To assess the values of transcutaneous oxygen tension (TcPO2) capable of predicting above-the-ankle amputation in diabetic patients diagnosed for critical limb ischemia (CLI) according to the criteria of the TransAtlantic Inter-Society Consensus. DESIGN: Retrospective study. METHODS: From January 1999 to December 2003, 564 diabetic patients were consecutively hospitalized for CLI in one limb. Revascularization with angioplasty or bypass graft was performed when possible and, if not possible, prostanoid therapy was used. In patients in whom therapies did not relieve the rest pain or the gangrene was extended above the Chopart joint, an above-the-ankle-amputation was performed. After treatment TcPO2 values were evaluated in all patients at the dorsum of the foot. RESULTS: Fifty-five (9.8%) patients underwent an above-the-ankle amputation: 22 of 420 patients who underwent angioplasty, 17 of 117 patients who underwent bypass (14.5%) and 16 of 27 patients in whom revascularization was not possible. Post-treatment TcPO2, measured by a receiver operating characteristic (ROC) curve, showed a value 34 mmHg as the best threshold for determining the need for revascularization, with an area under the curve of 0.89 (95%CI 0.85-0.94). Using logistic regression analysis the probability of above-the-ankle amputation for this threshold is 9.7% and reduces to 3% for TcPO2 > 40 mmHg. CONCLUSION: TcPO2 levels<34 mmHg indicate the need for revascularization, while for values >or= 34 < 40 mmHg this need appears less pressing, although there remains a considerable probability of amputation. TcPO2 levels greater than 40 mmHg suggest that revascularization is dependent on the severity of tissue loss and possible morbidity caused by the procedure.

Early and five-year amputation and survival rate of diabetic patients with critical limb ischemia: data of a cohort study of 564 patients.

OBJECTIVE: To evaluate the early and late major amputation and survival rates and related risk factors in diabetic patients with critical limb ischemia (CLI). DESIGN: Retrospective study. METHODS: Revascularization feasibility, major amputation, survival rate and related risk factors were recorded in 564 diabetic patients consecutively hospitalized for CLI from 1999 to 2003 and followed until June 2005. RESULTS: Peripheral angioplasty (PTA) was carried out in 420 (74.5%), bypass graft (BPG) in 117 (20.7%) patients. In 27 (4.8%) patients both PTA and BPG were not possible. Twenty-three above-the-ankle amputations (4.1%) were performed at 30 days: 6 in PTA patients, 3 in BPG patients, 14 in non revascularized patients. In the follow-up of 558 patients (98.9%), 62 repeated PTAs and 9 new BPGs, 32 new major amputations (16 in PTA patients, 14 in BPG patients and 2 in non-revascularized patients) were performed. Major amputation was associated with absence of revascularization (OR 35.9, p < 0.001, CI 12.9-99.7), occlusion of each of the three crural arteries (OR 8.20, p = 0.022, CI 1.35-49.6), wound infection (OR 2.1, p = 0.004 CI 1.3-3.6), dialysis (OR 4.7, p = 0.001 CI 1.9-11.7) increase in TcPO2 after revascularization (OR 0.80, p < 0.001 CI 0.74-0.87). One hundred seventy three patients died during follow-up and this was associated with age (HR 1.05, p < 0.001 CI 1.03-1.07), history of cardiac disease (HR 2.16, p < 0.001 CI 1.53-3.06), dialysis (HR 3.52, p < 0.001 CI 2.08-5.97), absence of revascularization (HR 1.68, p < 0.001, CI 1.29-2.19) and impaired ejection fraction (HR 1.08, p < 0.001, CI 1.05-1.09). CONCLUSIONS: In diabetic patients with CLI the revascularization is feasible in most cases and allows a low rate of early major amputation. This rate is higher in the follow-up period. Major amputation is very high in patients where revascularization is not feasible while the high mortality rate is due to the serious comorbidities observed in these patients.

Screening for peripheral arterial disease by means of the ankle-brachial index in newly diagnosed Type 2 diabetic patients.

AIM: To evaluate the prevalence of peripheral arterial disease (PAD) with the ankle-brachial index (ABI) in newly diagnosed Type 2 diabetic subjects. METHODS: Between autumn 2002 and spring 2003, 2559 newly diagnosed Type 2 diabetic subjects (about 15% of the cases/year in Italy) were enrolled in 265 diabetology centres. Family history of diabetes, smoking, height, weight, waistline, fasting glycaemia, glycosylated haemoglobin, total and HDL-cholesterol and triglyceride values were collected. Claudication, cyanosis, cold foot, foot hair anomalies, skin thinning and femoral, popliteal, posterior tibial and dorsalis pedis pulses were assessed. The ABI was measured with a portable Doppler continuous-wave instrument. RESULTS: An ABI < 0.9 was found in 539 (21.1%) patients. Claudication was present in 187 (7.3%). Femoral pulse was absent in 218 (8.5%), popliteal in 316 (12.3%), tibial in 563 (22.0%) and dorsalis pedis in 578 (22.6%). Foot cyanosis was observed in 88 (3.4%), cold foot in 359 (13.9%), skin thinning in 468 (18.3%) and hair anomalies in 857 (33.5%). Multivariate analysis of the variables associated with ABI < 0.9 in the univariate analysis confirmed the independent role of age [relative risk (RR) 1.02, P < 0.001, confidence interval (CI) 1.01, 1.04], claudication (RR 4.53, P < 0.001, CI 2.97, 6.93), absence of tibial pulse (RR 3.45, P < or = 0.001. CI 2.54, 4.68) and pedis pulse (RR 1.96, P < or = 0.001, CI 1.4, 2.68). CONCLUSIONS: PAD, as represented by ABI < 0.9, is common in newly diagnosed Type 2 diabetic patients.

Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003.

OBJECTIVE: To evaluate the effectiveness of peripheral angioplasty (PTA) as the first-choice revascularisation procedure in diabetic patients with critical limb ischemia (CLI). DESIGN: Prospective study. METHODS: PTA was employed as first choice revascularisation in a consecutive series of diabetic patients hospitalized for CLI between January 1999 and December 2003. RESULTS: PTA was successful performed in 993 patients. Seventeen (1.7%) major amputations were carried out. One death and 33 non-fatal complications were observed. Mean follow-up was 26+/-15 months. Clinical restenosis was observed in 87 patients. The 5 years primary patency was 88%, 95% CI 86-91%. During follow-up 119 (12.0%) patients died at a rate of 6.7% per year. CONCLUSIONS: PTA as the first choice revascularisation procedure is feasible, safe and effective for limb salvage in a high percentage of diabetic patients. Clinical restenosis was an infrequent event and PTA could successfully be repeated in most cases.

[Antidiabetic therapy in diabetic patients with coronary heart disease]. / La terapia antidiabetica del diabetico coronaropatico.

The role of metabolic control following acute myocardial infarction, (AMI) is still subject of study to date. The only study performed in diabetic patients with an AMI is the DIGAMI which demonstrated that endovenous insulin therapy in the acute phase, followed by multiple subcutaneous administrations of insulin therapy in the follow-up, was able to obtain not only a better metabolic control in both the acute phase and in the follow-up, but also a better survival only in the follow-up. Even if this latter fact is disappointing, endovenous insulin infusion seems to be the best approach to effectively contrast the metabolic events secondary to hyperglycemia which accompany AMI. From the DIGAMI study derives the indication of multiple insulin injections in diabetic patients having survived an AMI, even if doubt still exists as to whether it is the insulin therapy in itself or rather the metabolic compensation obtained that is responsible for a better survival rate. There is no controversy regarding the use of multiple (3 but above all 4/day) subcutaneous rapid insulin administrations at meal time and retard insulin administrations at bed time. Over the last few years ultrarapid insulin has become available as well the newcomer glargine, a retard insulin, which presents a homogeneous 24 hour release pattern. These insulin forms, obtained by genetic engineering, allow for a 4 daily dose administration, ultrarapid at meal times and glargine once daily, which mimic a more physiological insulin secretion and as such probably render them more efficacious. When oral drugs are opted for, it is imperative to have acquaintance with their half-lives, bonding properties with K(+)(ATP) channels, the antioxidant and antithromobophylic properties. It is necessary to modulate their use considering the glycemic daily rhythm in diabetics (glycemia tending to be high in the early morning and low in the evening). In order to obtain an optimal metabolic control it is essential to have the patient perform a glycemia level self-assessment by means of portable measuring instruments which employ instantaneous reactive strips. Self-assessment is imperative for the prevention of hypoglycemic episodes considered particularly dangerous in diabetic patients with coronary heart disease, even if studies which have demonstrated and documented this danger do not exist.

Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects.

OBJECTIVE: To evaluate the feasibility, technical effectiveness and limb salvage potential of percutaneous transluminal angioplasty (PTA), particularly infrapopliteal, in diabetic subjects with ischaemic foot ulcer. DESIGN: Intervention study with PTA in consecutive series. SETTING: Six Diabetology Foot Centres and one Cardiovascular Catheterization Laboratory in Italy. SUBJECTS: Two hundred and twenty-one consecutive diabetic subjects hospitalized for ischaemic foot ulcer. INTERVENTION: Peripheral arterial occlusive disease (PAOD) was investigated by means of foot pulses assessment, ankle-brachial-index (ABI), transcutaneous oxygen tension (TcPO2) and duplex scanning. If non-invasive parameters suggested PAOD, angiography was performed and a PTA was carried out during the same session. MAIN OUTCOME MEASURES: PTA feasibility, improvement of ABI and TcPO2, limb salvage rate, clinical recurrence. RESULTS: On angiography, two patients had stenoses which were <50% of the vessel diameter. PTA was performed in 191 (85.3%) of the 219 subjects with stenoses >50%, even when longer than 10 cm and/or multiple/calcified. In 11 patients (5.8%) PTA was performed in the proximal axis exclusively, in 81 (42.4%) patients in the infrapopliteal axis exclusively and in 99 (51.8%) in both the femoropopliteal and infrapopliteal axis. Both ABI and TcPO2 improved significantly after PTA (P < 0.0001). Clinical recurrence occurred in 14 subjects: 10 of whom underwent a second successful PTA. Of the 191 patients who underwent PTA, 10 (5.2%) underwent an above-the-ankle amputation. CONCLUSIONS: PTA, including infrapopliteal, is feasible in most diabetic subjects with ischaemic foot ulcer and is effective for foot revascularization. Clinical recurrence was infrequent and the procedure could successfully be repeated in most cases. In subjects treated successfully with PTA the above-the-ankle amputation rate was low. PTA should be considered as the revascularization treatment of first choice in all diabetic subjects with foot ulcer and PAOD.

New ulceration, new major amputation, and survival rates in diabetic subjects hospitalized for foot ulceration from 1990 to 1993: a 6.5-year follow-up.

OBJECTIVE: To evaluate 1) the new ulceration, the new major amputation, and the survival rates of 115 diabetic subjects hospitalized for foot ulceration from 1990 to 1993, with an average follow-up of 6.5 years, and 2) the demographic and clinical characteristics associated with these events. RESEARCH DESIGN AND METHODS: A total of 115 subjects, 31 women and 84 men, were monitored until 31 December 1998. All subjects were provided with therapeutic shoes and received intense education. Data concerning new ulceration, new major amputation, and reamputation events and the date and cause of death were recorded for each patient. The prognostic factors for these events were then evaluated. RESULTS: The average follow-up was 78.3 +/- 15.3 months (range 60-106). During this time, 13 homolateral and 12 contralateral episodes of new ulceration occurred. At univariate analysis, none of the variables considered were significantly associated with the new ulceration. There were three major amputations: two of the limb previously healed and one of the contralateral limb. Of the 115 subjects, 51 (44.3%) died: 24 of the 31 women (77.4%) and 27 of the 84 men (32.1%). Ischemic cardiopathy was the most frequent cause of death (60.8%). Mortality concerned 20 of the 27 subjects (74.1%) undergoing major amputation from 1990 to 1993 and 31 of the 88 healed subjects (35.2%), with a significant difference (P < 0.0001). Multivariate analysis showed the independent role of the ankle-brachial index < or =0.5 (P = 0.005), age (P = 0.003), and female sex (P = 0.027). CONCLUSIONS: We believe that the use of therapeutic shoes and intense educational training, including the education of the family, have contributed to the low incidence of new ulceration and major amputation in our study population. The high frequency of ischemic cardiopathy as a cause of death should, perhaps, lead to a more aggressive diagnostic and therapeutic attitude toward this pathology in diabetic subjects admitted to hospitals for foot ulceration.

Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study.

OBJECTIVE: To evaluate and compare the rate of reduction of the surface area of neuropathic plantar ulcers in diabetic patients treated with nonremovable rigidity-differentiated fiberglass off-bearing casts or a cloth shoe with a rigid sole with unloading alkaform insoles. The secondary aim was to evaluate the side effects and degree of patient acceptance of treatment. RESEARCH DESIGN AND METHODS: Fifty diabetic patients with neuropathic plantar ulcers were consecutively enrolled and randomized to one of two treatment groups. Of the 50 patients, 24 were treated with a specialized cloth shoe with a rigid sole and an unloading alkaform insole (shoe group), and 26 patients were treated with a nonremovable off-bearing fiberglass cast (cast group). All patients in both study groups returned to the clinic for weekly control visits. Their ulcers were treated with a standard dressing. Tracings of the ulcer area using a transparent dressing were performed on the day of entry to the study and after 30 days of treatment. The presence of new ulcerations caused by the use of the pressure-relief apparatus was recorded. Patient acceptance of the treatment was measured using a visual analog scale. RESULTS: At the end of the treatment period, an 8.3% increase of the ulcer area was observed in two patients in the shoe group, whereas in the cast group, no patient presented an increase. The reduction of the ulcer area was statistically more rapid in the cast group (Mann-Whitney test, P = 0.0004). Furthermore, the number of ulcers completely healed at the 30-day time point was 13 (50%) in the cast group and 5 (20.8%) in the shoe group (P = 0.03). In both groups, no side effects were recorded. The average score +/- SD of patient acceptance was 91.15 +/- 9.9 in the shoe group and 88.33 +/- 17.3 (NS) in the cast group. CONCLUSIONS: Our study has shown a significant difference in the speed of the reduction of neuropathic plantar ulcers treated with a fiberglass cast compared with a specialized cloth shoe. The use of fiberglass material with variable rigidity has also shown two important results: the elimination of side effects including ulcers caused by the cast, and high patient acceptance. These data show that the use of off-bearing casts made with fiberglass bandages of variable rigidity is the elective treatment of neuropathic plantar ulcers.

Angiographic evaluation of peripheral arterial occlusive disease and its role as a prognostic determinant for major amputation in diabetic subjects with foot ulcers.

OBJECTIVE: To evaluate in diabetic patients with foot ulcers the angiographic findings of peripheral occlusive arterial disease and their role as a prognostic determinant for major amputation. RESEARCH DESIGN AND METHODS: From 1993 to 1995, 104 diabetic inpatients with foot ulcers underwent arteriography on the ulcerated limb. Stenoses in the iliac trunk, the superficial femoral artery, the profunda femoral artery, the popliteal artery, the anterior tibial artery, the posterior tibial artery, and the peroneal artery were scored on the basis of vessel lumen reduction: 0 if stenoses involved a reduction in the vessel lumen of < 50%, 1 if stenoses involved 50 to < 75% reduction, 2 if stenoses involved 75 to < 100% reduction, and 3 if total occlusion was present. The sum of the points assigned to each of these arteries was called the angiographic score. RESULTS: Stenoses causing a vessel lumen reduction > or = 50% were detected in 103 patients (99%). Stenoses were also detected in subjects with palpable foot pulses, ankle-brachial indexes > or = 1, or transcutaneous oxygen tension > or = 50 mmHg. The risk of major amputation was increased significantly when total occlusion was present in the popliteal and infrapopliteal arteries (chi 2 for trend = 50.57, P < 0.001). No major amputation was carried out in patients with angiographic scores < 10; major amputation was carried out in all the patients with scores > 14. Multivariate analysis indicated a high angiographic score as an independent risk factor for major amputation (odds ratio 2.32, P = 0.001, CI 1.40-3.84). CONCLUSIONS: Angiography permits an exact detection of occlusive arterial disease in subjects with normal results for noninvasive vascular procedures. A score that has a relevant prognostic value for major amputation can be obtained from the evaluation of the extent and diffusion of the stenoses.

Change in major amputation rate in a center dedicated to diabetic foot care during the 1980s: prognostic determinants for major amputation.

From 1990 to 1993, 115 diabetic patients were consecutively hospitalized in our diabetologic unit for foot ulcer and 27 (23.5%) major amputations were carried out. The major amputation rate of this series of cases was compared with that occurring in diabetic subjects taken into our hospital for foot ulcer in two previous periods: 1979-1981 (17 major amputations in 42 inpatients or 40.5%) and 1986-1989 (26 major amputations in 78 inpatients or 33.3%). The comparison shows a progressive reduction in major amputation rate [Odds ratio 0.66, 95% confidence interval (CI) 0.46-0.96]. Univariate and multivariate analysis, carried out in the population of the 1990-1993 period, in order to detect the independent factors associated with major amputation show the following prognostic determinants of major amputation: Wagner grade (odds ratio 7.69, CI 1.58-37.53), prior stroke (odds ratio 35.05, CI 3.14-390.53), prior major amputation (odds ratio 3.49, CI 1.26-9.38), transcutaneous oxygen level (odds ratio 1.06, CI 1.01-1.12), and ankle-brachial blood pressure index (odds ratio 4.35, CI 1.58-12.05), while an independent protective role was attributed to hyperbaric oxygen treatment (odds ratio 0.15, CI 0.03-0.64). In accordance with other studies, we, therefore, conclude that a comprehensive protocol as well as a multidisciplinary approach in a dedicated center can assure a decrease in major amputation rate. The parameters of limb perfusion were the modifiable prognostic determinants most strongly predictive for amputation.

Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer. A randomized study.

OBJECTIVE: To evaluate the effectiveness of systemic hyperbaric oxygen therapy (s HBOT) in addition to a comprehensive protocol in decreasing major amputation rate in diabetic patients hospitalized for severe foot ulcer. RESEARCH DESIGN AND METHODS: From August 1993 to August 1995, 70 diabetic subjects were consecutively admitted into our diabetologic unit for foot ulcers. All the subjects underwent our diagnostic-therapeutic protocol and were randomized to undergo s-HBOT. Two subjects, one in the arm of the treated group and one in the arm of nontreated group, did not complete the protocol and were therefore excluded from the analysis of the results. Finally, 35 subjects received s-HBOT and another 33 did not. RESULTS: Of the treated group (mean session = 38.8 +/- 8), three subjects (8.6%) underwent major amputation: two below the knee and one above the knee. In the nontreated group, 11 subjects (33.3%) underwent major amputation: 7 below the knee and 4 above the knee. The difference is statistically significant (P = 0.016). The relative risk for the treated group was 0.26 (95% CI 0.08-0.84). The transcutaneous oxygen tension measured on the dorsum of the foot significantly increased in subjects treated with hyperbaric oxygen therapy: 14.0 +/- 11.8 mmHg in treated group, 5.0 +/- 5.4 mmHg in nontreated group (P = 0.0002). Multivariate analysis of major amputation on all the considered variables confirmed the protective role of s-HBOT (odds ratio 0.084, P = 0.033, 95% CI 0.008-0.821) and indicated as negative prognostic determinants low ankle-brachial index values (odds ratio 1.715, P = 0.013, 95% CI 1.121-2.626) and high Wagner grade (odds ratio 11.199, P = 0.022, 95% CI 1.406-89.146). CONCLUSIONS: s-HBOT, in conjunction with an aggressive multidisciplinary therapeutic protocol, is effective in decreasing major amputations in diabetic patients with severe prevalently ischemic foot ulcers.

Feasibility and effectiveness of peripheral percutaneous transluminal balloon angioplasty in diabetic subjects with foot ulcers.

OBJECTIVE: The aim of this study was to evaluate the feasibility and effectiveness of this vascular procedure in diabetic inpatients with foot ulcers. RESEARCH DESIGN AND METHODS: In 80 consecutive inpatient diabetic subjects with a foot ulcer, an angiographic study of the lower limbs was carried out to evaluate the necessity and possibility of performing vascular procedures. In 22 subjects, vascular procedure was not necessary; in 26 subjects, peripheral transluminal angioplasty was carried out; in 10 subjects, angioplasty was considered impossible and a peripheral bypass graft was performed; and in 22 subjects, no vascular procedure was considered possible. RESULTS: Of the 26 angioplasties, 8 were performed in iliac or femoral arteries and 18 were performed in the popliteal artery and its branches. The angioplasty was considered unsuccessful in 4 subjects and successful in 22. After angioplasty, on discharge, parameters of limb perfusion improved significantly: transcutaneous oxygen tension was 27.0 +/- 14 mm/Hg on admission and 44.6 +/- 14 mm/Hg on discharge (P < 0.001); ankle-brachial index was 0.61 +/- 0.23 on admission and 0.77 +/- 0.20 on discharge (P = 0.018). Of 22 subjects who underwent successful angioplasty, 21 ended the follow-up of 12 months: during this period, they showed no relapses in the salvaged limb, and their parameters of limb perfusion did not significantly vary. CONCLUSIONS: Angioplasty is feasible in a large percentage of diabetic subjects with peripheral occlusive arterial disease and foot ulcer and is often also practicable in the popliteal artery and its branches. In these subjects, angioplasty significantly improves the parameters of limb perfusion. Angioplasty is therefore an important therapeutic tool in ulcerated diabetic foot care.

Coronary angiography and aorto-coronary bypass surgery in type 2 diabetic patients.

Diabetic and non-diabetic subjects with angina who underwent angiography and were subsequently treated surgically or medically and followed up for 5 years were analysed in order to assess coronary angiographic findings, efficacy of coronary artery bypass grafting and prognostic criteria in Type 2 diabetic patients with angina as compared to non-diabetic subjects. A total of 1853 of non-diabetic and 145 diabetic subjects underwent angiography, including respectively 857 and 68 who had surgery. Perioperative mortality, survival, reinfarction and asymptomaticity rates were measured. Multivariate analysis of risk factors and clinical features was performed. Diabetic patients had a higher frequency of multi-vessel stenoses (p < 0.001), a greater diffusion of stenoses (p < 0.005) and worse left ventricular motion (p < 0.005). No differences were found in perioperative infarction and mortality. Operated diabetic patients had a higher survival rate (p < 0.001) and a longer symptom-free period (p < 0.05) than unoperated diabetic patients. Operated diabetic patients had similar survival and more frequent recurrence of angina (p < 0.05) than operated non-diabetic patients. Survival rate was lower for unoperated diabetic patients than unoperated non-diabetic patients (p < 0.05). Recurrence of angina was similar. Multivariate analysis did not indicate diabetes as a factor affecting survival. It is concluded that surgery for Type 2 diabetic patients with coronary artery disease is a suitable therapeutic option conferring a reduction in mortality regardless of the presence of diabetes.

Manufactured shoes in the prevention of diabetic foot ulcers.

OBJECTIVE: To evaluate the efficacy of manufactured shoes specially designed for diabetic patients (Podiabetes by Buratto Italy) to prevent relapses of foot ulcerations. RESEARCH DESIGN AND METHODS: A prospective multicenter randomized follow-up study of patients with previous foot ulcerations was conducted. Patients were alternatively assigned to wear either their own shoes (control group, C; n = 36) or therapeutic shoes (Podiabetes group, P; n = 33). The number of ulcer relapses was recorded during 1-year follow-up. RESULTS: Both C and P groups had similar risk factors for foot ulceration (i.e., previous foot ulceration, mean vibratory perception threshold > 25 mV). After 1 year, the foot ulcer relapses were significantly lower in P than in C (27.7 vs. 58.3%; P = 0.009; odds ratio 0.26 [0.2-1.54]). In a multiple regression analysis, the use of therapeutic shoes was negatively associated with foot ulcer relapses (coefficient of variation = -0.315; 95% confidence interval = -0.54 to -0.08; P = 0.009). CONCLUSIONS: The use of specially designed shoes is effective in preventing relapses in diabetic patients with previous ulceration.

[Results of revascularization and amputation of the gangrenous diabetic foot. Importance of a multidisciplinary approach]. / Risultati della rivascolarizzazione ed amputazione nella gangrena diabetica del piede. Importanza dell'approccio multidisciplinare.

A total of 89 diabetic patients with foot lesions were treated using amputation during the past 5 years at Niguarda-Ca' Grande Hospital. All patients suffered from gangrene which in 76% of cases was classified as Wagner's stage IV. The lesion was infected in 67 patients. Emergency surgical cleansing was performed in order to drain abscesses and remove necrotic tissue, taking care not to damage healthy tissue. An accurate multidisciplinary study was performed in all cases which included neurological, oculistic and vascular assessment. 83% of patients presented retinopathy and 62.5% were nephropathic. Angiographic tests revealed the presence of distal vascular lesions in 90% of cases. A femoro-distal by-pass was used in 17 cases and the limb was salvaged in 13 patients; ileal-femoral PTA was performed in 10 cases and the limb was salvaged in 7 patients. Amputations were limited wherever possible to distal segments: toes (55 cases), transmetatarsal (12 case), leg (12 cases), thigh (5 cases), atypical resections or ample cleansing of the foot (5 cases). This approach allowed us to record: 1) a low operative mortality (1 case); 2) higher quality of life; 3) the possibility of reoperating on more proximal portions of the limb in the event of immediate or long-term failure. This was necessary in 19 cases which can be classified as follows: reamputation of toe (11 cases), transmetatarsal (4 cases), amputation of leg (4 cases).