Peripheral Arterial Occlusive DiseaseNCT03935776
Lifestyle Modification Programme for Patients With Peripheral Arterial Disease
A study testing Risk Factors Modification Programme and Standard Healthcare in people with Peripheral Arterial Occlusive Disease, run by Western Vascular Institute, Ireland at 1 site in Ireland.
Trial summary
This trial randomises patients with occlusive peripheral arterial disease, to be managed either by providing a 12-week structured lifestyle modification programme, or standard healthcare. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- Risk Factors Modification Programme and Standard Healthcare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2018to 1 Sep 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or more
- Provide written informed consent
- PAD: diagnosed by at least one of the following:
- Ankle-brachial index of less than 0.90 in at least one lower extremity(10)
- Toe brachial index of less than 0.609
- Evidence of arterial occlusive disease in one lower extremity detected by duplex ultrasonography, computed tomographic angiography, or magnetic resonance angiography(10)
Show all 20Show fewer
- Symptomatic PAD (Rutherford category 2 and above(11)
- Patients should have at least one of the following risk factors:
- Blood pressure > 140/80 mmHg
- Fasting Blood Sugar (FBS) >53 mmol/mol
- HbA1c >7%
- Total cholesterol >5 mmol/L
- LDL cholesterol >2.6 mmol/L
- Triglycerides >1.7 mmol/L
- HDL <1.0 mmol/L in men and <1.2 mmol/L in women
- Physical activity less 30 minutes for 5 days per week
- BMI 25>kg/m2
- Waist circumference >80 cm in women, and >94 cm in men.
- Current smoker or exposure to tobacco in any form
- Unhealthy diet, Mediterranean diet score less than 10 points
Who cannot join
- Rutherford category zero or one(11)
- Involvement in another clinical trial in the previous six months
- Legal incapacity
- Inadequate English language
- Significant cognitive impairment or mental illness
- Inadequate English language
Show all 11Show fewer
- Significant cognitive impairment or mental illness
- Refusal to participate in a certain part of the intervention
- Mental and physical inability to participate in the structured programme
- Pregnant (confirmed by β-human chorionic gonadotropion (HCG) analysis).
- Contraindication to anticoagulation and antiplatelet medications or any of the risk factors treatment.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Galway
Sherif Sultan, MD, +35391542534, sherif.sultan@hse.ie
Wael Tawfick, MD, +35391542535, wael.tawfick@hse.ie
About this study
Official title: The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme
This trial randomises patients with occlusive peripheral arterial disease, to be managed either by providing a 12-week structured lifestyle modification programme, or standard healthcare.
Read the detailed description
Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events.
Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease.
Because PAD represents a peripheral manifestation of atherosclerosis, most traditional and novel cardiovascular risk factors are strongly associated with this condition. Smoking, diabetes, hyperlipidaemia, hypertension, unhealthy diet, and physical inactivity were identified as significant modifiable risk factors that should be targeted for secondary prevention.
Atherosclerotic risk factor identification and modification plays an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. Because of the efficacy of these techniques, several expert committees have recommended their use in patients with PAD. Despite clear guidelines, several studies have shown that patients with PAD are routinely undertreated for these risk factors, which may contribute to high rates of morbidity and mortality.
Our trial will evaluate the impact of a 12-week, structured lifestyle and risk factor modification programme on medical and lifestyle risk factors modification, as well as on clinical vascular outcomes, among patients with peripheral arterial disease. We will compare these outcomes to that of standard healthcare traditionally provided to this high-risk patient group.
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- Risk Factors Modification Programme, Standard Healthcare
- Keywords
- Peripheral arterial disease, Risk factor modifications, Cardiovascular risk factors
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Factors Modification ProgrammeBehavioural
12- week supervised risk factor modification programme derived from the Euroaction study standards
Standard HealthcareBehavioural
Patients are advised to adjust lifestyle without the support of the structured supervised programme
| Study group | Role | What they receive |
|---|---|---|
| Risk Factors Modification Programme | Experimental | * Patients in the intervention arm will attend a 12-week intensive lifestyle programme.
* The intervention includes weekly exercise class and educational workshops, serial blood pressure, body mass index, glucose and lipid measurements.
* Weekly multidisciplinary team meetings and targeted and protocol pharmacotherapy to support lifestyle changes. Receives: Behavioral: Risk Factors Modification Programme |
| Standard Healthcare | Active comparator | The control group will receive information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan. Receives: Behavioral: Standard Healthcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle and medical risk factor modification
Achieving target Improvement in lifestyle risk factors. Target improvement will be considered if the patient achieves any one or more of the following:
- Smoking cessation
- Body mass index 20-25 (kg/m^2). BMI is calculated by dividing body weight in kilograms by the square of height in meters
- Glycosylated haemoglobin (HbA1c) less than 7%
- Total Cholesterol less than 5.0 mmol/L
Measured: at 12 weeks
Secondary outcomes (5)
Amputation free survival
if the patient underwent a major amputation and level of amputation
Measured: 1 year
Re-intervention or stenosis rate
Any re-intervention or stenosis among patients who already underwent vascular surgery
Measured: 1 year
Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
If the patient developed a major adverse cardiovascular event (MACE) or major adverse limb event (MALE)
Measured: 1 year
Revascularisation-free survival
if the patient underwent any revascularisation procedure
Measured: 1 year
Health related quality of life
assessed using the Dartmouth Cooperative Information Project (COOP) charts at enrolment and after one year.
The COOP charts measure six core aspects of functional status: physical fitness, feelings, daily activities, social activities, change in health, pain, and overall health. The instrument consists of six charts, referring to the above mentioned aspects of functioning. Each chart consists of a simple title, a question referring to the status of the patient and an ordinal five-point response scale illustrated with a simple drawing.
Each item is rated on this five-point ordinal scale ranging from 1 (no limitation at all) to 5 (severely limited); for 'change in health' score 1 means 'much better' and score 5 'much worse'. The designers do not advocate summing the responses to gain a single index figure of health status.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Jun 2018
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Occlusive 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
- Model description
- This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Vascular Institute, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael Tawfick, MB BcH,MRCSI, Principal investigator, Western Vascular Institute, IrelandSherif Sultan, MB BcH,MRCSI, Principal investigator, Western Vascular Institute, IrelandMarah Elfghi, MB BcH, MSc, Study director, Western Vascular Institute, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935776
- Sponsor's protocol ID
- WVI-PAD
- Status last verified
- Aug 2021
- First submitted
- 15 Feb 2019
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality
Publications
Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
PubMed 23915883Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, Powe NR, Siscovick D. Ankle-arm index as a predictor of cardiovascular disease and mortality in the Cardiovascular Health Study. The Cardiovascular Health Study Group. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):538-45. doi: 10.1161/01.atv.19.3.538.
PubMed 10073955Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
PubMed 11560536Becker GJ, McClenny TE, Kovacs ME, Raabe RD, Katzen BT. The importance of increasing public and physician awareness of peripheral arterial disease. J Vasc Interv Radiol. 2002 Jan;13(1):7-11. doi: 10.1016/s1051-0443(07)60002-5. No abstract available.
PubMed 11788688Criqui MH, Fronek A, Klauber MR, Barrett-Connor E, Gabriel S. The sensitivity, specificity, and predictive value of traditional clinical evaluation of peripheral arterial disease: results from noninvasive testing in a defined population. Circulation. 1985 Mar;71(3):516-22. doi: 10.1161/01.cir.71.3.516.
PubMed 3156007Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
PubMed 16549646Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
PubMed 17223489Shen C, Li W. [Interpretation and consideration of the Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities management of asymptomatic disease and claudication]. Zhonghua Wai Ke Za Zhi. 2016 Feb 1;54(2):81-3. doi: 10.3760/cma.j.issn.0529-5815.2016.02.001. Chinese.
PubMed 26876071Lu JT, Creager MA. The relationship of cigarette smoking to peripheral arterial disease. Rev Cardiovasc Med. 2004 Fall;5(4):189-93.
PubMed 15580157Mahe G, Kaladji A, Le Faucheur A, Jaquinandi V. Internal Iliac Artery Disease Management: Still Absent in the Update to TASC II (Inter-Society Consensus for the Management of Peripheral Arterial Disease). J Endovasc Ther. 2016 Feb;23(1):233-4. doi: 10.1177/1526602815621757. No abstract available.
PubMed 26763263Rutherford 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 9308598Elfghi M, Jordan F, Dunne D, Gibson I, Jones J, Flaherty G, Sultan S, Tawfick W. The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme-for a randomised controlled trial protocol. Trials. 2021 Feb 13;22(1):138. doi: 10.1186/s13063-021-05087-x.
PubMed 33581715
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme
- ClinicalTrials.gov ID
- NCT03935776
- Acronym / sponsor ID
- WVI-PAD
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Peripheral arterial disease, Risk factor modifications, Cardiovascular risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Western Vascular Institute, IrelandUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 2 May 2019 (actual)
- 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.
This trial randomises patients with occlusive peripheral arterial disease, to be managed either by providing a 12-week structured lifestyle modification programme, or standard healthcare.
Detailed description
Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events.
Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease.
Because PAD represents a peripheral manifestation of atherosclerosis, most traditional and novel cardiovascular risk factors are strongly associated with this condition. Smoking, diabetes, hyperlipidaemia, hypertension, unhealthy diet, and physical inactivity were identified as significant modifiable risk factors that should be targeted for secondary prevention.
Atherosclerotic risk factor identification and modification plays an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. Because of the efficacy of these techniques, several expert committees have recommended their use in patients with PAD. Despite clear guidelines, several studies have shown that patients with PAD are routinely undertreated for these risk factors, which may contribute to high rates of morbidity and mortality.
Our trial will evaluate the impact of a 12-week, structured lifestyle and risk factor modification programme on medical and lifestyle risk factors modification, as well as on clinical vascular outcomes, among patients with peripheral arterial disease. We will compare these outcomes to that of standard healthcare traditionally provided to this high-risk patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Risk Factors Modification Programme | Experimental | Behavioral: Risk Factors Modification Programme* Patients in the intervention arm will attend a 12-week intensive lifestyle programme. * The intervention includes weekly exercise class and educational workshops, serial blood pressure, body mass index, glucose and lipid measurements. * Weekly multidisciplinary team meetings and targeted and protocol pharmacotherapy to support lifestyle changes. |
| Standard Healthcare | Active comparator | Behavioral: Standard HealthcareThe control group will receive information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Aged 18 years or more
- Provide written informed consent
- PAD: diagnosed by at least one of the following:
- Symptomatic PAD (Rutherford category 2 and above(11)
- Patients should have at least one of the following risk factors:
Key exclusion criteria (11 listed)
- Rutherford category zero or one(11)
- Involvement in another clinical trial in the previous six months
- Legal incapacity
- Inadequate English language
- Significant cognitive impairment or mental illness
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 |
|---|---|---|
| Risk Factors Modification Programme12- week supervised risk factor modification programme derived from the Euroaction study standards | Behavioural | Risk Factors Modification Programme |
| Standard HealthcarePatients are advised to adjust lifestyle without the support of the structured supervised programme | Behavioural | Standard Healthcare |
Primary outcome
Lifestyle and medical risk factor modification
Time frame: at 12 weeks
Achieving target Improvement in lifestyle risk factors. Target improvement will be considered if the patient achieves any one or more of the following: 1. Smoking cessation 2. Body mass index 20-25 (kg/m^2). BMI is calculated by dividing body weight in kilograms by the square of height in meters 3. Glycosylated haemoglobin (HbA1c) less than 7% 4. Total Cholesterol less than 5.0 mmol/L
5 secondary outcomes
Amputation free survival
Time frame: 1 year
Re-intervention or stenosis rate
Time frame: 1 year
Freedom from major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
Time frame: 1 year
Revascularisation-free survival
Time frame: 1 year
Health related quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 23915883Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
- Background: PubMed 10073955Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, Powe NR, Siscovick D. Ankle-arm index as a predictor of cardiovascular disease and mortality in the Cardiovascular Health Study. The Cardiovascular Health Study Group. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):538-45. doi: 10.1161/01.atv.19.3.538.
- Background: PubMed 11560536Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
- Background: PubMed 11788688Becker GJ, McClenny TE, Kovacs ME, Raabe RD, Katzen BT. The importance of increasing public and physician awareness of peripheral arterial disease. J Vasc Interv Radiol. 2002 Jan;13(1):7-11. doi: 10.1016/s1051-0443(07)60002-5. No abstract available.
- Background: PubMed 3156007Criqui MH, Fronek A, Klauber MR, Barrett-Connor E, Gabriel S. The sensitivity, specificity, and predictive value of traditional clinical evaluation of peripheral arterial disease: results from noninvasive testing in a defined population. Circulation. 1985 Mar;71(3):516-22. doi: 10.1161/01.cir.71.3.516.
- Background: PubMed 16549646Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
- Background: PubMed 17223489Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
- Background: PubMed 26876071Shen C, Li W. [Interpretation and consideration of the Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities management of asymptomatic disease and claudication]. Zhonghua Wai Ke Za Zhi. 2016 Feb 1;54(2):81-3. doi: 10.3760/cma.j.issn.0529-5815.2016.02.001. Chinese.
- Background: PubMed 15580157Lu JT, Creager MA. The relationship of cigarette smoking to peripheral arterial disease. Rev Cardiovasc Med. 2004 Fall;5(4):189-93.
- Background: PubMed 26763263Mahe G, Kaladji A, Le Faucheur A, Jaquinandi V. Internal Iliac Artery Disease Management: Still Absent in the Update to TASC II (Inter-Society Consensus for the Management of Peripheral Arterial Disease). J Endovasc Ther. 2016 Feb;23(1):233-4. doi: 10.1177/1526602815621757. No abstract available.
- 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.
- Derived from this study: PubMed 33581715Elfghi M, Jordan F, Dunne D, Gibson I, Jones J, Flaherty G, Sultan S, Tawfick W. The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme-for a randomised controlled trial protocol. Trials. 2021 Feb 13;22(1):138. doi: 10.1186/s13063-021-05087-x.
- Individual participant dataSharing planned: Undecided. Individual patient data of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality
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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.
Wael Tawfick, MB BcH,MRCSI principal investigator
Western Vascular Institute, Ireland
Sherif Sultan, MB BcH,MRCSI principal investigator
Western Vascular Institute, Ireland
Marah Elfghi, MB BcH, MSc study director
Western Vascular Institute, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Factors Modification Programme and Standard Healthcare in people with Peripheral Arterial Occlusive Disease, run by Western Vascular Institute, Ireland at 1 site in Ireland.
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 20 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 4 Aug 2021. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wael Tawfick, MB BcH,MRCSI (+ 35391542535, wael.tawfick@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle and medical risk factor modification (time frame: at 12 weeks). 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 NCT03935776, which also lists 12 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 4 Aug 2021.