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document
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 .
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Intervention_Pharmacological
Heparan sulfate
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Intervention_Pharmacological
heparan sulfate ( 40 mg orally twice a day )
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Intervention_Control
placebo
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Intervention_Pharmacological
heparan sulfate
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Outcome_Physical
walking capacity
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Outcome_Pain
pain-free walking distance
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Outcome_Other
claudication distance ( ICD ) ]
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Outcome_Pain
pain-free and the absolute walking distance ( ACD )
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Outcome_Other
initial claudication distance
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Outcome_Physical
Functional recovery
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Outcome_Physical
walking capacity
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Participant_Condition
intermittent claudication
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Participant_Condition
intermittent claudication ( stages IIa and IIb of Fontaine 's PAD classification )