Clinical Trial: Trial of Nonsurgical Treatment of Intermittent Claudication Due to Femoro-popliteal Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomised Controlled Trial of Percutaneous Transluminal Angioplasty (PTA) Versus a Supervised Exercise Programme (SEP) in the Management of Intermittent Claudication (IC)

Brief Summary: Intermittent Claudication (IC)is a common condition characterised by pain in the muscles of the legs on exertion caused by "hardening of the arteries" and a reduced blood supply. The investigators know that the vast majority of people suffering from this condition remain stable and do not deteriorate, and thus in general the viability of legs is not at risk. The main aim of treatment, therefore, is to try and improve walking thus reducing the impact this problem has on patients life style. There are many methods of management of intermittent claudication, but the investigators do not know which produces the best results. This study aims to compare the short and medium term outcomes of exercise programmes, percutaneous transluminal angioplasty and a combination of the two treatments for patients with intermittent claudication.

Detailed Summary:

Intermittent claudication (IC) is a common problem in the UK's elderly population with a prevalence of 5 -10%. Intermittent claudication infers significant quality of life limitations, however, it is a disease which generally runs a benign course with >80% of patients remaining stable. Yet the annual mortality rate in claudicants approaches 5%, three times that of age and sex matched population, due to the high prevalence of co-morbidity. IC is under-recognised as a risk factor for coronary and cerebrovascular events. Sixty percent of claudicants die from coronary heart disease and 10% of them die from stroke. Treating the patient with claudication, therefore, is likely to pay high dividends in terms of reducing deaths from myocardial infarction and stroke. The most appropriate management of IC, therefore remains a topic for debate but potentially beneficial therapies include: supervised exercise programmes (SEP); & percutaneous transluminal angioplasty (PTA).

A recent Cochrane review of PTA versus non-surgical management for intermittent claudication highlighted only two appropriate studies. More recently the results of a randomized control trial from Sweden have been published. This emphasizes the dearth of reliable scientific data in this area. It is believed that aorta-iliac atherosclerosis is often a solitary disease as opposed to femoro-popliteal disease which is often a manifestation of more generalized atherosclerosis. Further, the 5-year PTA patency rates for aorta-iliac disease are much better than those for femoro-popliteal PTA. Therefore, PTA is a well-established treatment modality for aorta-iliac disease but its role in femoro-popliteal disease is debatable11. This trial aims to prove the most effective treatment modality for claudication due to femoro-popliteal disease.

The two treatment modalities in
Sponsor: University of Hull

Current Primary Outcome:

  • Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) [ Time Frame: Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment ]
  • Ankle brachial pressure indices(ABPI) measured at rest and post exercise [ Time Frame: Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient Reported Walking Distances (PRWD) [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ]
  • Clinical outcomes(PTA patency,re-intervention rates, fatal&non-fatal events,amputation,mortality and ISCVS outcome) [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ]
  • Health economic analyses [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ]
  • Markers of ischaemia reperfusion [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment ]
  • Heat-shock proteins [ Time Frame: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment. ]


Original Secondary Outcome: Same as current

Information By: University of Hull

Dates:
Date Received: November 25, 2008
Date Started: August 2002
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2015