Femoropopliteal DiseaseNCT00798850
Trial of Nonsurgical Treatment of Intermittent Claudication Due to Femoro-popliteal Disease
A study testing Percutaneous Transluminal Angioplasty (PTA), Supervised Exercise Programme (SEP) and Combined Treatment in people with Femoropopliteal Disease and Intermittent Claudication, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoropopliteal Disease, Intermittent Claudication
- What is being tested?
- Percutaneous Transluminal Angioplasty (PTA), Supervised Exercise Programme (SEP) and Combined Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2002to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic unilateral Intermittent Claudication Femoro-popliteal lesion Angioplastiable lesion on duplex > 3 months on BMT
Who cannot join
- Critical ischaemia Incapacitating systemic disease Inability to tolerate treadmill testing Ischaemic changes on ECG during treadmill testing Ipsilateral surgery / PTA in previous 6 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary
Hull, East Riding Of Yorkshire, HU3 2JZ
About this study
Official title: Randomised Controlled Trial of Percutaneous Transluminal Angioplasty (PTA) Versus a Supervised Exercise Programme (SEP) in the Management of Intermittent Claudication (IC) Due to Femoro-popliteal Disease
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.
Read the detailed description
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 question work by different mechanisms. PTA increases the blood flow to the limb. Whereas, exercise works by a combination of factors including optimized structural and metabolic performance of skeletal muscle, improvement in rheological parameters, development of collaterals, improved walking technique and marked psychological benefit. Still the efficacy of any treatment modality in claudication is judged by improvements in the standard measures of lower limb ischaemia as suggested by the International Society of Cardiovascular Surgery (ISCVS). These are essentially segmental pressure measurements and walking distances.
The primary aim of any treatment for patients with peripheral vascular disease is to improve the quality of life (QoL) rather than prolong survival. Several studies have shown that the traditional measures of lower limb ischaemia bear little correlation to the patient's QoL and these therefore need to be assessed independently. Further, generic QoL measures on their own are not sensitive enough to detect minor changes in QoL and so disease-specific measures need to be included in the outcomes.
Evidence is accumulating that each episode of exercise to the onset of claudication pain followed by rest may be considered as a low-grade ischaemia-reperfusion injury (IRI). Repeated episodes of IRI may have a cumulative effect leading to vascular endothelial damage and progression of atherosclerosis. This may explain the excess cardiovascular mortality seen in these patients16. Most experimental work measuring the biochemical markers of IRI is done following an episode of acute exercise. Few studies have shown the effect of an exercise -training programme on the biochemical markers of IRI. We intend to investigate this as a secondary component to the trial.
Heat shock proteins (hsp) are ubiquitous proteins found in the cells of all organisms. They are mainly classified according to their molecular weight. In addition to being constitutively expressed heat shock proteins can be induced by a number of stressors including heat, ischaemia and oxidative stress. Members of the hsp70 family are the most extensively studied group of stress proteins and they have been implicated in the prevention of ischaemia-reperfusion induced apoptosis, necrosis and oxidative injury in a variety of cell types including the cardiac myocyte18. Studies have shown hsp and their antibodies in the serum of normal individuals. Anti-hsp70 antibody levels in serum have been shown to be higher in vascular patients (IC, critical ischaemia and aortic aneurysms). Heat shock proteins have been detected in atherosclerotic lesions in higher concentrations. It is postulated that hsp play a key role in the autoimmune pathogenesis of atherosclerosis. Levels of anti-hsp antibodies are elevated in patients with carotid and coronary atherosclerosis and this correlates with the degree of atherosclerosis. Measuring anti-hsp antibodies in patients with IC undergoing exercise over a period of time may provide further valuable evidence on the role of heat shock proteins in atherosclerosis.
The secondary outcome measures of cost effectiveness analysis will interest health planners and clinicians as the health service has limited resources and 'value for money' has become increasingly important.
- Conditions
- Femoropopliteal Disease, Intermittent Claudication
- Being tested
- Percutaneous Transluminal Angioplasty (PTA), Supervised Exercise Programme (SEP), Combined Treatment
- Keywords
- Claudication, Vascular claudication, Peripheral Vascular Disease, Peripheral arterial disease, Peripheral arterial occlusive disease, Angioplasty, Femoral angioplasty, Superficial femoral artery, Femoral arterial disease, Exercise, Supervised exercise, Exercise therapy, Exercise programme, Infrainuginal, Quality of life, SF36, Questionnaire, VascuQol, Randomised, Randomised trial
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Transluminal Angioplasty (PTA)Procedure or surgery
PTA will be performed by a consultant interventional radiologist with no deviation from the standard protocol at Hull \& East Yorshire Yospitals NHS Trust.
Supervised Exercise Programme (SEP)Procedure or surgery
SEP: Conducted 3 times per week for 12 weeks.The session will be supervised by a physiotherapist and conducted in the cardiac gym.
Each session begins with gentle warming up exercises followed by an exercise circuit of 6 stations(2 minutes each).
- Station 1-Step-ups(20-cm high step,alternating leg after 10 step-ups)
- Station 2-Exercise bicycles
- Station 3-Knee extensions with weights(2kg beanbag)
- Station 4-Heel raises
- Station 5-Knee bends(Alternating legs after 10 bends)
- Station 6-Rest station(2Kg Biceps curls) Gentle walk for 2minutes in between the stations to recover.For first 6weeks patients complete one full circuit, followed by on extra station/week, thus by 12weeks patients will complete 2 full circuits.Finally patients perform a series of gentle stretching and cooling down exercises.
This exercise programme was designed to comply with suggested guidelines based on a meta-analysis assessing the effectiveness of SEP for claudicants.
Combined TreatmentProcedure or surgery
PTA will be performed according to routine protocol followed by enrollment of patient in SEP. SEP will commence in the week following PTA.
| Study group | Role | What they receive |
|---|---|---|
| PTA | Active comparator | Not described Receives: Procedure: Percutaneous Transluminal Angioplasty (PTA) |
| SEP | Active comparator | Not described Receives: Procedure: Supervised Exercise Programme (SEP) |
| PTA+SEP | Active comparator | Not described Receives: Procedure: Combined Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD)
Measured: Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment
Ankle brachial pressure indices(ABPI) measured at rest and post exercise
Measured: Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment
Secondary outcomes (5)
Patient Reported Walking Distances (PRWD)
Measured: 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)
Measured: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment
Health economic analyses
Measured: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment
Markers of ischaemia reperfusion
Measured: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment
Heat-shock proteins
Measured: Pre-treatment, 1, 3, 6, 12, 36, & 60 months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startAug 2002
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Femoropopliteal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Peter T McCollum, FRCS, Principal investigator, Academic Vascular Surgery Unit, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798850
- Sponsor's protocol ID
- HEY- REF-2424
- Status last verified
- Jul 2019
- First submitted
- 25 Nov 2008
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Fowkes FG, Housley E, Cawood EH, Macintyre CC, Ruckley CV, Prescott RJ. Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. Int J Epidemiol. 1991 Jun;20(2):384-92. doi: 10.1093/ije/20.2.384.
PubMed 1917239Chetter IC, Spark JI, Dolan P, Scott DJ, Kester RC. Quality of life analysis in patients with lower limb ischaemia: suggestions for European standardisation. Eur J Vasc Endovasc Surg. 1997 Jun;13(6):597-604. doi: 10.1016/s1078-5884(97)80070-6.
PubMed 9236714van der Heijden FH, Eikelboom BC, Banga JD, Mali WP. Management of superficial femoral artery occlusive disease. Br J Surg. 1993 Aug;80(8):959-63. doi: 10.1002/bjs.1800800806.
PubMed 8402088Leng GC, Lee AJ, Fowkes FG, Whiteman M, Dunbar J, Housley E, Ruckley CV. Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol. 1996 Dec;25(6):1172-81. doi: 10.1093/ije/25.6.1172.
PubMed 9027521Smith GD, Shipley MJ, Rose G. Intermittent claudication, heart disease risk factors, and mortality. The Whitehall Study. Circulation. 1990 Dec;82(6):1925-31. doi: 10.1161/01.cir.82.6.1925.
PubMed 2242518Davies A. The practical management of claudication. BMJ. 2000 Oct 14;321(7266):911-2. doi: 10.1136/bmj.321.7266.911. No abstract available.
PubMed 11030662Phillips MJ, Cowan AR, Johnson CD. Intermittent claudication should not be treated by surgery. Ann R Coll Surg Engl. 1997 Jul;79(4):264-7.
PubMed 9244069Fowkes FG, Gillespie IN. Angioplasty (versus non surgical management) for intermittent claudication. Cochrane Database Syst Rev. 2000;(2):CD000017. doi: 10.1002/14651858.CD000017.
PubMed 10796469Gelin J, Jivegard L, Taft C, Karlsson J, Sullivan M, Dahllof AG, Sandstrom R, Arfvidsson B, Lundholm K. Treatment efficacy of intermittent claudication by surgical intervention, supervised physical exercise training compared to no treatment in unselected randomised patients I: one year results of functional and physiological improvements. Eur J Vasc Endovasc Surg. 2001 Aug;22(2):107-13. doi: 10.1053/ejvs.2001.1413.
PubMed 11472042Chetter IC, Spark JI, Kent PJ, Berridge DC, Scott DJ, Kester RC. Percutaneous transluminal angioplasty for intermittent claudication: evidence on which to base the medicine. Eur J Vasc Endovasc Surg. 1998 Dec;16(6):477-84. doi: 10.1016/s1078-5884(98)80237-2.
PubMed 9894486Ernst E. Exercise: the best therapy for intermittent claudication? Br J Hosp Med. 1992 Sep 16-Oct 6;48(6):303-4, 307.
PubMed 1422544Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
PubMed 9308598Barletta G, Perna S, Sabba C, Catalano A, O'Boyle C, Brevetti G. Quality of life in patients with intermittent claudication: relationship with laboratory exercise performance. Vasc Med. 1996;1(1):3-7. doi: 10.1177/1358863X9600100102.
PubMed 9546911Garratt AM, Ruta DA, Abdalla MI, Buckingham JK, Russell IT. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? BMJ. 1993 May 29;306(6890):1440-4. doi: 10.1136/bmj.306.6890.1440.
PubMed 8518640Tisi PV, Hulse M, Chulakadabba A, Gosling P, Shearman CP. Exercise training for intermittent claudication: does it adversely affect biochemical markers of the exercise-induced inflammatory response? Eur J Vasc Endovasc Surg. 1997 Nov;14(5):344-50. doi: 10.1016/s1078-5884(97)80283-3.
PubMed 9413374
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Percutaneous Transluminal Angioplasty (PTA) Versus a Supervised Exercise Programme (SEP) in the Management of Intermittent Claudication (IC) Due to Femoro-popliteal Disease
- ClinicalTrials.gov ID
- NCT00798850
- Acronym / sponsor ID
- HEY- REF-2424
- Conditions
- Femoropopliteal Disease, Intermittent Claudication
- Keywords
- Claudication, Vascular claudication, Peripheral Vascular Disease, Peripheral arterial disease, Peripheral arterial occlusive disease, Angioplasty, Femoral angioplasty, Superficial femoral artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Aug 2002
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 question work by different mechanisms. PTA increases the blood flow to the limb. Whereas, exercise works by a combination of factors including optimized structural and metabolic performance of skeletal muscle, improvement in rheological parameters, development of collaterals, improved walking technique and marked psychological benefit. Still the efficacy of any treatment modality in claudication is judged by improvements in the standard measures of lower limb ischaemia as suggested by the International Society of Cardiovascular Surgery (ISCVS). These are essentially segmental pressure measurements and walking distances.
The primary aim of any treatment for patients with peripheral vascular disease is to improve the quality of life (QoL) rather than prolong survival. Several studies have shown that the traditional measures of lower limb ischaemia bear little correlation to the patient's QoL and these therefore need to be assessed independently. Further, generic QoL measures on their own are not sensitive enough to detect minor changes in QoL and so disease-specific measures need to be included in the outcomes.
Evidence is accumulating that each episode of exercise to the onset of claudication pain followed by rest may be considered as a low-grade ischaemia-reperfusion injury (IRI). Repeated episodes of IRI may have a cumulative effect leading to vascular endothelial damage and progression of atherosclerosis. This may explain the excess cardiovascular mortality seen in these patients16. Most experimental work measuring the biochemical markers of IRI is done following an episode of acute exercise. Few studies have shown the effect of an exercise -training programme on the biochemical markers of IRI. We intend to investigate this as a secondary component to the trial.
Heat shock proteins (hsp) are ubiquitous proteins found in the cells of all organisms. They are mainly classified according to their molecular weight. In addition to being constitutively expressed heat shock proteins can be induced by a number of stressors including heat, ischaemia and oxidative stress. Members of the hsp70 family are the most extensively studied group of stress proteins and they have been implicated in the prevention of ischaemia-reperfusion induced apoptosis, necrosis and oxidative injury in a variety of cell types including the cardiac myocyte18. Studies have shown hsp and their antibodies in the serum of normal individuals. Anti-hsp70 antibody levels in serum have been shown to be higher in vascular patients (IC, critical ischaemia and aortic aneurysms). Heat shock proteins have been detected in atherosclerotic lesions in higher concentrations. It is postulated that hsp play a key role in the autoimmune pathogenesis of atherosclerosis. Levels of anti-hsp antibodies are elevated in patients with carotid and coronary atherosclerosis and this correlates with the degree of atherosclerosis. Measuring anti-hsp antibodies in patients with IC undergoing exercise over a period of time may provide further valuable evidence on the role of heat shock proteins in atherosclerosis.
The secondary outcome measures of cost effectiveness analysis will interest health planners and clinicians as the health service has limited resources and 'value for money' has become increasingly important.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PTA | Active comparator | Procedure: Percutaneous Transluminal Angioplasty (PTA) |
| SEP | Active comparator | Procedure: Supervised Exercise Programme (SEP) |
| PTA+SEP | Active comparator | Procedure: Combined Treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic unilateral Intermittent Claudication Femoro-popliteal lesion Angioplastiable lesion on duplex > 3 months on BMT
Key exclusion criteria (1 listed)
- Critical ischaemia Incapacitating systemic disease Inability to tolerate treadmill testing Ischaemic changes on ECG during treadmill testing Ipsilateral surgery / PTA in previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Transluminal Angioplasty (PTA)PTA will be performed by a consultant interventional radiologist with no deviation from the standard protocol at Hull \& East Yorshire Yospitals NHS Trust. | Procedure or surgery | PTA |
| Supervised Exercise Programme (SEP)SEP: Conducted 3 times per week for 12 weeks.The session will be supervised by a physiotherapist and conducted in the cardiac gym. Each session begins with gentle warming up exercises followed by an exercise circuit of 6 stations(2 minutes each). 1. Station 1-Step-ups(20-cm high step,alternating leg after 10 step-ups) 2. Station 2-Exercise bicycles 3. Station 3-Knee extensions with weights(2kg beanbag) 4. Station 4-Heel raises 5. Station 5-Knee bends(Alternating legs after 10 bends) 6. Station 6-Rest station(2Kg Biceps curls) Gentle walk for 2minutes in between the stations to recover.For first 6weeks patients complete one full circuit, followed by on extra station/week, thus by 12weeks patients will complete 2 full circuits.Finally patients perform a series of gentle stretching and cooling down exercises. This exercise programme was designed to comply with suggested guidelines based on a meta-analysis assessing the effectiveness of SEP for claudicants. | Procedure or surgery | SEP |
| Combined TreatmentPTA will be performed according to routine protocol followed by enrollment of patient in SEP. SEP will commence in the week following PTA. | Procedure or surgery | PTA+SEP |
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
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Background: PubMed 1917239Fowkes FG, Housley E, Cawood EH, Macintyre CC, Ruckley CV, Prescott RJ. Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. Int J Epidemiol. 1991 Jun;20(2):384-92. doi: 10.1093/ije/20.2.384.
- Background: PubMed 9236714Chetter IC, Spark JI, Dolan P, Scott DJ, Kester RC. Quality of life analysis in patients with lower limb ischaemia: suggestions for European standardisation. Eur J Vasc Endovasc Surg. 1997 Jun;13(6):597-604. doi: 10.1016/s1078-5884(97)80070-6.
- Background: PubMed 8402088van der Heijden FH, Eikelboom BC, Banga JD, Mali WP. Management of superficial femoral artery occlusive disease. Br J Surg. 1993 Aug;80(8):959-63. doi: 10.1002/bjs.1800800806.
- Background: PubMed 9027521Leng GC, Lee AJ, Fowkes FG, Whiteman M, Dunbar J, Housley E, Ruckley CV. Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol. 1996 Dec;25(6):1172-81. doi: 10.1093/ije/25.6.1172.
- Background: PubMed 2242518Smith GD, Shipley MJ, Rose G. Intermittent claudication, heart disease risk factors, and mortality. The Whitehall Study. Circulation. 1990 Dec;82(6):1925-31. doi: 10.1161/01.cir.82.6.1925.
- Background: PubMed 11030662Davies A. The practical management of claudication. BMJ. 2000 Oct 14;321(7266):911-2. doi: 10.1136/bmj.321.7266.911. No abstract available.
- Background: PubMed 9244069Phillips MJ, Cowan AR, Johnson CD. Intermittent claudication should not be treated by surgery. Ann R Coll Surg Engl. 1997 Jul;79(4):264-7.
- Background: PubMed 10796469Fowkes FG, Gillespie IN. Angioplasty (versus non surgical management) for intermittent claudication. Cochrane Database Syst Rev. 2000;(2):CD000017. doi: 10.1002/14651858.CD000017.
- Background: PubMed 11472042Gelin J, Jivegard L, Taft C, Karlsson J, Sullivan M, Dahllof AG, Sandstrom R, Arfvidsson B, Lundholm K. Treatment efficacy of intermittent claudication by surgical intervention, supervised physical exercise training compared to no treatment in unselected randomised patients I: one year results of functional and physiological improvements. Eur J Vasc Endovasc Surg. 2001 Aug;22(2):107-13. doi: 10.1053/ejvs.2001.1413.
- Background: PubMed 9894486Chetter IC, Spark JI, Kent PJ, Berridge DC, Scott DJ, Kester RC. Percutaneous transluminal angioplasty for intermittent claudication: evidence on which to base the medicine. Eur J Vasc Endovasc Surg. 1998 Dec;16(6):477-84. doi: 10.1016/s1078-5884(98)80237-2.
- Background: PubMed 1422544Ernst E. Exercise: the best therapy for intermittent claudication? Br J Hosp Med. 1992 Sep 16-Oct 6;48(6):303-4, 307.
- Background: PubMed 9308598Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter T McCollum, FRCS principal investigator
Academic Vascular Surgery Unit, University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Transluminal Angioplasty (PTA), Supervised Exercise Programme (SEP) and Combined Treatment in people with Femoropopliteal Disease and Intermittent Claudication, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (time frame: Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00798850, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.