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PubMed2002

Heparan sulfate in the treatment of intermittent claudication: results of a randomized, double-blind, placebo-controlled multicenter trial.

Peripheral arterial disease (PAD) is by far the most common cause of intermittent claudication. This disease can greatly reduce the affected individual's walking capacity and can seriously affect daily life activities. Few therapeutic options are aimed at improving walking capacity. This was a randomized, doubleblind, placebo-controlled, multicenter trial, performed in 24 Italian centers. Two hundred seventeen patients with intermittent claudication (stages IIa and IIb of Fontaine's PAD classification) were randomly assigned to heparan sulfate (40 mg orally twice a day) or placebo for 6 months. The primary end-point was an increase in pain-free walking distance [initial claudication distance (ICD)] during the 24 weeks of treatment. The pain-free and the absolute walking distance (ACD) were monitored by standardized treadmill test at baseline and at 4, 12 and 24 weeks. The change in initial claudication distance during treatment, expressed as integrated change over time, was significantly greater with heparan sulfate than with placebo (306 +/- 494 vs. 250 +/- 510 meters x months, p = 0.019). Significantly fewer treated patients worsened during treatment (decreased initial claudication distance) compared with controls (9.1% vs. 19.6%; p = 0.027). Functional recovery in the most severely affected subgroup of patients (stage IIb of Fontaine's classification) was more clearly detected and significantly greater among treated than among control patients (absolute increase in ICD: 70 +/- 113 vs. 58 +/- 172 meters, p = 0.028; integrated increase: 304 +/- 422 vs. 208 +/- 503 meters x months; p = 0.004). Heparan sulfate appeared to increase the walking capacity of patients with intermittent claudication to a significantly greater extent than did placebo. The treatment was well tolerated.

Aged↗
PubMed2002

Coagulation in diabetic and non-diabetic claudicants.

BACKGROUND: In order to compare hemostasis in diabetic and non-diabetic claudicants we evaluated endothelial (von Willebrand factor, vWF), rheologic (fibrinogen, hematocrit), coagulation system (thrombin-antithrombin complex, TAT) and platelet (platelet factor 4, PF4, aggregation on thrombin, collagen and ADP stimulation) parameters in both groups and healthy controls. METHODS: Twenty-five diabetic, 34 non-diabetic patients with claudication and 26 healthy individuals were enrolled into the study. RESULTS: The severity of lower limbs ischemia was similar in two groups of claudicants but coronary heart disease and cerebral ischemia were significantly more common in diabetic than in non-diabetic claudicants. vWF level was significantly higher in diabetic than non-diabetic claudicants and healthy controls (184+/-43%, 147+/-43%, and 103+/-42%, respectively). Fibrinogen was significantly higher in diabetic and non-diabetic claudicants compared to controls (4.2+/-1.7, and 3.9+/-1.1, versus 2.9+/-0.5 g/l) and TAT plasma concentration was much higher in diabetic compare to non-diabetic patients and controls (9.8+/-4.4, 1.7+/-1.1, and 1.3+/-0.6 microg, respectively). PF4 concentration was significantly higher in non-diabetic patients with PAOD (34+/-29 UI/ml) when compare to healthy controls (14+/-9 UI/ml), but diabetic PAOD patients with the disease showed lower PF4 concentration (26+/-30 UI/ml). Platelet aggregation with all used activators was similar in all groups likewise hematocrit values, and platelet count. CONCLUSIONS: Complicated DM is linked with significant endothelial perturbation when compared with healthy, but also with PAOD individuals; rheologic parameters are not different from those found in PAOD patients; coagulation system activation but not platelet hyperactivity is associated with DM complicated by PAOD when compared to both control groups.

Blood Coagulation↗
PubMed1991

[Blood and plasma viscosity versus claudication distance in patients with obliterative atherosclerosis of the lower limbs].

The aim of the investigations was to show the influence of increased blood and plasma viscosity on the claudication distance in patients with obliterative atherosclerosis of lower limbs. The investigations were carried out in 53 patients: 41 men and 12 women (group I, age 45-67 years). The control group consisted of 100 healthy persons (group II) with similar range of age. The rheological studies of blood were carried out by low-shear 100 Contraves viscometer, the plasma viscosity--by means of capillary viscometer. Moreover, the total lipids, alpha, pre-beta, beta-lipoproteins, triglycerides, total cholesterol, free fatty acids, fibrinogen and hematocrit of the blood were determined. The blood for above mentioned estimations was collected before testing of the claudication distance. A significant increase of blood and plasma has been shown as well as an increase of total lipids, fibrinogen, triglycerides, total cholesterol, free fatty acids. The alpha lipoproteins were significant decreased in patients with intermittent claudication compared to the controls. The claudication distance ranged 10-500 m (the mean: 143 +/- 119 m). The correlation between claudication distance and blood and plasma viscosity was significantly negative (r = -0.42, p less than 0.001 and r = -0.32, p less than 0.05 respectively). The obtained results indicated that an increase of blood and plasma viscosity in patients with obliterative atherosclerosis of lower limbs was correlated to the decrease of claudication distance.

Aged↗
PubMed1989

[The prognosis of intermittent claudication].

The purpose of this study is to obtain the informations about the fate of the limbs and lives of claudicants due to arteriosclerosis obliterans. Two hundred and seven lower limbs of 165 patients suffering from intermittent claudication were observed for an average period of about six years. Eighty-seven limbs of 69 patients were managed nonsurgically (Group A). Ninety-eight percent of limbs in Group A remained unchanged or improved, and no limb was amputated. One hundred and twenty limbs of 96 patients had arterial reconstructions (Group B). Although 75 percent of limbs in Group B had benefits by successful operations, 26 percent of them experienced graft failures, and 2.7 percent of them were amputated. Five year graft patency rates in the limbs with supra- and infra-inguinal reconstructions were 82.1 percent and 65.7 percent, respectively. Operative mortality rate was 2.1 percent, and mortality rate due to late complications was 3.3 percent. The prognosis of intermittent claudication with regular follow-up was relatively good, therefore, it is important to recognize that arterial reconstruction is not the only way to treat limbs with mild intermittent claudication. About 30 percent of claudicants died within 5 years, and 60 percent of them died from cardiac or cerebrovascular disease. The results suggested that much attention should be paid to the lives as well as the limbs of claudicants.

Aged↗
PubMed1987

A controlled trial of pentoxifylline (Trental 400) in intermittent claudication: clinical, haemostatic and rheological effects.

A formulation of pentoxifylline (Trental 400) has been claimed to increase claudication distance by improving red cell deformability and decreasing blood viscosity and platelet aggregation. In order to test this claim 30 stable claudicants recruited from one population took part in a double-blind randomised trial of placebo versus pentoxifylline. Both placebo and pentoxifylline treated patients improved subjectively and increased their claudication distance over the study period. Analysis of the blood results showed that the only apparent change was a tendency towards increased red cell filtration in the group treated with pentoxifylline; but no significant difference was found between claudicants and normal controls in the degree of red cell filterability nor did red cell filterability correlate with claudication distance. Pentoxifylline did not affect claudication distance or have any useful effect on blood flow properties, calling into question both its efficacy and suggested mode of action.

Adult↗
PubMed1994

[The effectiveness of standardized exercise training in intermittent claudication].

In stage II peripheral arterial occlusive disease (PAOD) physical training is generally the therapy of choice if no reopening procedures are indicated. The aim of this pilot study was to ascertain the increase in claudication distance due to the exclusive implementation of an intensive exercise programme under standardized conditions, for a planned double blind placebo controlled study regarding the efficacy of pharmacotherapy in addition to physical training. 23 in-patients (median age 62 years) with an absolute claudication distance on treadmill of between 50 m and 200 m (12% inclination, 3 km/h walking speed) participated 5 days a week in the following intensive standardized physical training programme: in the morning and afternoon supervised gymnastics for about 30 minutes, followed by 2 cycles of treadmill exercise each amounting to 66% of the absolute claudication distance. After a training programme of 4 weeks the mean initial claudication distance rose significantly from 83 m to 134 m (61%), as did the mean absolute claudication distance from 127 m to 222 m (75%). If an increase in claudication distance of at least 60% is taken as criterion of efficacy, 48% of the patients can be defined as responders. After completion of personal inquiries 62% of the patients were willing to participate in a similar training programme again.

Exercise Test↗
PubMed1997

Claudication distance is poorly estimated and inappropriately measured.

BACKGROUND: Claudication distance is the commonest measure of the disability caused by lower-limb occlusive arterial disease. The accuracy of claudication distance as a surrogate for handicap has been assessed. METHODS: Seventy patients who attended a specialist vascular clinic with intermittent claudication were studied prospectively. Patients were asked to estimate their claudication distance and maximum walking distance before undergoing both a patient-controlled corridor walk and a fixed-speed treadmill walk. RESULTS: The claudication distance reported by patients bore little relation to the distance recorded in the medical correspondence. There was no correlation between the estimated distance and the actual distance walked on either a patient-controlled corridor walk or a fixed-speed treadmill walk. Most patients were able to walk substantially further at their own speed on the corridor than on the treadmill at a slower speed. CONCLUSION: Claudication distance is spuriously estimated, inaccurately reported, falsely recorded, inappropriately measured and usually misinterpreted. It is of little value in judging the need for treatment. Objective measures of the handicap caused by the disability of reduced walking distance are required if rational management decisions are to be made.

Adult↗
PubMed1997

Repeated exercise induces release of soluble P-selectin in patients with intermittent claudication.

Controversy exists as to whether exercise in patients with intermittent claudication causes a harmful biochemical effect associated with an ischaemia-reperfusion injury of skeletal muscle. We report on exercise-induced changes in neutrophil activation, soluble P-selectin and von Willebrand factor in 34 patients with intermittent claudication and 12 matched controls. Von Willebrand factor (vWF) showed a cyclical pattern of response to exercise in control subjects (rising from 103 +/- 8 to 119 +/- 7 U/dl); claudicants did not show this pattern but had higher levels of vWF throughout (p <0.03). There was no consistent pattern of response in neutrophil hydrogen peroxide production to exercise in either claudicants or control subjects. Soluble P-selectin levels increased after exercise, but this only reached statistical significance after repeated exercise in claudicants (rising from 320 +/- 28 to 357 +/- 28 ng/ml). This rise in soluble P-selectin after exercise may indicate progressive platelet activation which may contribute to the excess cardiovascular mortality that claudicants are prone to.

Adult↗
PubMed1998

The effect of indirect calorimetry measurement on claudication pain in patients with peripheral arterial occlusive disease.

The effect of indirect calorimetry measurement on the duration to onset and maximal claudication pain and hemodynamic measures was evaluated. Fifteen male patients with peripheral arterial occlusive disease (PAOD) performed two graded exercise tests (GXTs) in random order, one with and the other without the use of indirect calorimetry measurement. During the tests the time to onset and maximal claudication pain was recorded. Before and after the tests, ankle/brachial systolic pressure index (ABI) was determined. The time to onset of claudication pain was shorter for the test with indirect calorimetry (4:49+/-3:50 vs 5:44+/-4:39 min:sec, p < 0.005). Time to maximal claudication pain was not significantly different between the two conditions (8:58+/-3:01 min:sec with indirect calorimetry, 9:39+/-3:36 min:sec, without). There were no significant differences in ABI between the two testing sessions at any time point. Results of this study suggest that indirect calorimetry measurement can be utilized without compromising maximal claudication pain time or hemodynamic measurements but that time to onset of claudication pain is hastened with indirect calorimetry measurement in patients with PAOD.

Aged↗
PubMed1988

Risk factors affecting the natural history of intermittent claudication.

To determine the prognostic significance of the level of arterial disease in claudicators, risk factors affecting the progression of intermittent claudication, including hemodynamic variables obtained from noninvasive vascular laboratory examinations, were assessed. We identified 378 patients with intermittent claudication by characteristic history and the presence of abnormal treadmill exercise examination results. Results of serial examinations were available for 195 of these patients, who had 310 claudicating limbs. Life-table analysis revealed that after eight years, 41% of these patients had progressed to critical ischemia, defined as rest pain or tissue loss, and 50% had died. Cox proportional hazards general linear regression analysis found that at a patient's first examination in the vascular laboratory, the ankle-brachial index and the decrease in ankle-brachial index after exercise were significantly associated with the subsequent development of critical ischemia. The level of disease at the initial examination in the vascular laboratory was not a significant risk factor for progression to critical ischemia and therefore should not be used as an indicator for or against operation in patients with intermittent claudication.

Adult↗
PubMed1998

The acute outcome of tibioperoneal vessel angioplasty in 417 cases with claudication and critical limb ischemia.

A non-randomized, consecutive series of 417 first procedure tibioperoneal vessel angioplasty (TPVA) cases were analyzed to determine if angioplasty were an alternative revascularization technique for critical limb ischemia (CLI) and claudicants patients. TPVA was performed on 312 patients (70% male; age 66 +/- 10 years) with success attained in 406/417 cases (96%) of 605/657 lesions (92%): [461/469 stenoses (98%) and 144/188 occlusions (77%) *(P < 0.05)]. Claudication and CLI patients had similar rates of success. In claudication patients clinical success was 130/133 (98%); lesion success was 197/208 (92%); stenosis was 148/151 (98%); and occlusion was 49/57 (86%). In CLI patients clinical success was 270/284 (95%); lesion success was 408/449 (91%); stenosis was 313/318 (98%); and occlusion was 95/131 (73%). We conclude that TPVA is an effective revascularization technique for obstructed tibioperoneal vessels, with excellent success in stenotic (98%) and reasonable results in occluded vessels (77%). These data demonstrate TPVA effectiveness in CLI patients and in carefully selected claudicants with appropriate indications (severe, lifestyle limiting claudication) and readily amenable anatomy, and TPVA for CLI patients appears to be an effective revascularization technique.

Acute Disease↗
PubMed2006

Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication.

BACKGROUND: Although exercise therapy is considered to be of significant benefit to people with leg pain (intermittent claudication), almost half of those affected do not undertake any exercise therapy. OBJECTIVES: To evaluate the effects of supervised versus non-supervised exercise therapy on the maximal walking time or distance for people with intermittent claudication. SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases Group searched their Specialized Register (last searched November 2005) and the Cochrane Central Register of Controlled Trials (CENTRAL) database in The Cochrane Library (last searched Issue 4, 2005). In addition, we handsearched the reference lists of relevant articles for additional trials. There was no restriction on language of publication. SELECTION CRITERIA: Randomized and controlled clinical trials comparing supervised exercise programs with non-supervised exercise programs for people with intermittent claudication. DATA COLLECTION AND ANALYSIS: Two authors (BB and EMW) independently selected trials and extracted data. One author (BB) assessed trial quality and this was confirmed by a second author (MP). For all continuous outcomes we extracted the number of participants, the mean differences, and the standard deviation. If data were available, the standardized mean difference was calculated using a fixed-effect model. MAIN RESULTS: We identified twenty-seven trials, of which 19 had to be excluded because the control group received no exercise therapy at all. The remaining eight trials involved a total of 319 male and female participants with intermittent claudication. The follow up ranged from 12 weeks to 12 months. In general, the supervised exercise regimens consisted of three exercise sessions per week. All trials used a treadmill walking test as one of the outcome measures. The overall quality of the included trials was good, though the trials were all small with respect to the number of participants, ranging from 20 to 59. Supervised exercise therapy showed statistically significant and clinically relevant differences in improvement of maximal treadmill walking distance compared with non-supervised exercise therapy regimens, with an overall effect size of 0.58 (95% confidence interval 0.31 to 0.85) at three months. This translates to a difference of approximately 150 meters increase in walking distance in favor of the supervised group. AUTHORS' CONCLUSIONS: Supervised exercise therapy is suggested to have clinically relevant benefits compared with non-supervised regimens, which is the main prescribed exercise therapy for people with intermittent claudication. However, the clinical relevance has not been demonstrated definitely and will require additional studies with a focus on the improvements in quality of life.

Directly Observed Therapy↗
PubMed1990

Effect of surgery on the systemic inflammatory response to intermittent claudication.

The hypothesis that intermittent claudication initiates a systemic inflammatory response was investigated by studying the effect of exercise on markers of neutrophil activation and vascular permeability in 25 claudicants and 10 controls. Urinary albumin excretion, previously demonstrated to reflect vascular permeability, increased significantly after exercise in claudicants and was associated with decreased neutrophil filterability and increased serum lysozyme activity. No similar exercise-induced changes were seen in controls or in claudicants after successful arterial bypass surgery. These results suggest that intermittent claudication is associated with potentially deleterious systemic manifestations that are surgically reversible.

Aged↗
PubMed1994

Neutrophils may contribute to the morbidity and mortality of claudicants.

Peripheral arterial occlusive disease is a common cause of morbidity in middle-aged men; 5 per cent of those aged over 50 years suffer from intermittent claudication. While claudication itself is not fatal, claudicants have a mortality rate approximately three times that of non-claudicating men of the same age, mainly from cardiovascular disease. This review examines the evidence for involvement of the neutrophil in this increased mortality and describes the possible pathogenesis. It also discusses how treatment of claudication may modify neutrophil behaviour, reducing subsequent mortality and morbidity rates.

Aged↗
PubMed1997

Near infrared spectroscopy for noninvasive assessment of claudication.

The purpose of this study was to explore the application of near-infrared spectroscopy (NIRS) to the assessment of peripheral arterial occlusive disease (PAOD). Muscle blood flow, oxygen consumption, arterial inflow capacity, O2 resaturation, and recovery times were determined at rest, under ischemic and hyperemic conditions, and continuously during and after walking exercise in 11 claudicants and 15 nonclaudicants. Blood flow and oxygen consumption (VO2) at rest and blood flow following walking exercise did not differ significantly between claudicants and nonclaudicants. In contrast, VO2 after walking exercise was increased by a factor 4.1 in claudicants compared to a factor of 1.7 in nonclaudicants. The oxygen resaturation rate after arterial occlusion and the oxygen resaturation rate after walking exercise were significantly lower in claudicants. Claudicants showed a higher degree of hemoglobin deoxygenation during walking exercise than nonclaudicants. A high postexercise VO2 is correlated with a low ankle-branchial index (ABI). The resaturation rates and recovery times following walking exercise and arterial occlusion correlated significantly with ABI parameters. A significant negative correlation was found between hemoglobin deoxygenation during exercise and the ABI parameters. A high correlation was observed between the oxygenated hemoglobin (O2Hb) recovery time and the ABI recovery time after walking exercise. NIRS appears to be an effective noninvasive method for assessing the imbalance between oxygen demand and oxygen delivery in the leg muscles of PAOD patients at rest and during exercise.

Adult↗
PubMed2002

Pentoxifylline reverses oxidative mitochondrial defect in claudicating skeletal muscle.

OBJECTIVE: Previous morphologic studies and phosphorus nuclear magnetic resonance spectroscopy (31P MRS) have suggested a primary mitochondrial defect in claudicating skeletal muscle. We hypothesized that pentoxifylline may alleviate this defect. METHODS: The response of calf muscle bioenergetics to pentoxifylline was evaluated in 10 male, nondiabetic claudicants with 31P MRS and standard treadmill testing before and after 12 weeks of pentoxifylline therapy. Phosphocreatine (PCr) and adenosinodiphosphate (ADP) recovery rate constants, two very sensitive measures of oxidative mitochondrial function, were measured. RESULTS: Seven of the 10 subjects had abnormal baseline PCr (<0.015 s(-1)) and ADP (<0.024 s(-1)) recovery rate constants. These 7 had significant improvement in mitochondrial function with pentoxifylline; their PCr recovery rate constants increased from 0.009 +/- 0.002 to 0.013 +/- 0.002 s(-1) (P = 0.013) and their ADP recovery rate constants increased from 0.015 +/- 0.002 to 0.022 +/- 0.002 s(-1) (P = 0.004). The remaining 3 patients had normal baseline constants and demonstrated no improvement after pentoxifylline therapy. Baseline PCr and ADP recovery rate constants inversely correlated with their corresponding percentage of improvement after pentoxifylline (P < 0.05). In addition the percentage of improvement in the PCr and ADP recovery rate constants correlated with the percentage of improvement in initial claudication distance and maximum walking capacity (P < 0.05). CONCLUSIONS: Pentoxifylline improves the mitochondriopathy of claudicating muscle, producing the most improvement in limbs with the worse baseline mitochondrial function. These results point to a potential new mode of action for pentoxifylline in the treatment of claudication and identify a subgroup of patients with the best potential for improvement with treatment.

Aged↗
PubMed2002

Enhancing foot skin blood flux in peripheral vascular disease using intermittent pneumatic compression: controlled study on claudicants and grafted arteriopaths.

Intermittent pneumatic leg compression (IPC) increases arterial calf inflow and foot skin blood flux in normal subjects and claudicants. Our hypothesis was that IPC could enhance foot skin blood flux after infrainguinal grafting and thus promote distal perfusion in limbs with tissue loss. The aim of this study was to compare the effects of three IPC modes [applied to the foot (IPCfoot), the calf (IPCcalf), or both (IPCfoot+calf)] on foot skin perfusion in healthy individuals, claudicants, and patients after infrainguinal arterial revascularization performed for critical or subcritical limb ischemia. Altogether, 20 healthy limbs, 22 claudicating limbs, and 36 limbs of arteriopaths with prior successful autologous femoropopliteal and femorodistal (18 each) grafts were examined. Five-minute laser Doppler recordings were obtained from the pulp of the big toe in the sitting position, at rest, and during random applications of IPCfoot, IPCcalf, and IPCfoot+calf delivered at 120 mmHg for 4 seconds three times per minute. Foot skin blood flux increased using all IPC modes (p <0.001), with IPCfoot and IPCfoot+calf generating higher flux levels than IPCcalf (p <0.01) in all groups. Intergroup differences of flux with each of the three IPC modes were not significant. IPCfoot and IPCfoot+calf similarly (p > 0.14) produced a higher percentage flux increase than IPCcalf in all groups (p <0.004). Controls had a higher percentage flux increase with both IPCcalf and IPCfoot than did claudicants (p? 0.016). No differences were documented between normal and grafted limbs (p > 0.05). The percentage flux increase with IPCfoot+calf and IPCcalf was significantly higher in femorodistal grafts than in femoropopliteal ones (p ? 0.026). IPC enhances skin blood flux in limbs with infrainguinal bypass, claudication, and normal arteries, with IPCfoot and IPCfoot+calf being more effective than IPCcalf. Our findings suggest that IPC may be beneficial in limbs with impaired distal perfusion and thus may have clinical implications in the treatment of leg ulcers either prior to or after revascularization.

Aged↗
PubMed1999

Motor conduction alterations in patients with lumbar spinal stenosis following the onset of neurogenic claudication.

The pathogenesis of neurogenic claudication is thought to lie in relative ischemia of cauda equina roots during exercise. In this study we will evaluate the effect of the transient ischemia brought on by exercise on motor conduction in patients suffering from lumbar spinal stenosis (LSS). We will also evaluate the sensitivity of motor evoked potentials (MEPs) in detecting motor conduction abnormalities before and after the onset of neurogenic claudication. Thirty patients with LSS and 19 healthy volunteers were enrolled in the study. All LSS patients had a history of neurogenic claudication and the diagnosis was confirmed with a CT myelogram. Both groups underwent a complete electrophysiological evaluation of the lower extremities. The motor evoked potential latency time (MEPLT) and the peripheral motor conduction time (PMCT) were measured. The subjects were asked to walk on a flat surface until their symptoms were reproduced. A new set of electrophysiological tests was then performed. Exercise did not produce claudication in any of the control group subjects. Twenty-seven patients did have claudication. The pre-exercise MEPLT and nerve conduction studies in the control group fell within the normal range. In the patient group, 19 patients had increased baseline values for MEPLT to at least one muscle. There was a significant difference between the MEPLT and the PMCT values measured before and after exercise in the patients with signs of neurological deficit. This difference was not found to be significant in patients without neurological deficits (t-test P < 0. 05). It may be concluded that exercise increases the sensitivity of MEPs in detecting the roots under functional compression in LSS.

Adult↗