Peripheral Artery DiseasePULV-2011NCT01382056
Effects of Pulse Varieties on Blood Vessel Function in Peripheral Artery Disease
A study testing Mixed bean (higher amount) and Mixed beans (lower amount) in people with Peripheral Artery Disease, run by University of Manitoba at 1 site in Canada.
Trial summary
Consumption of a diet containing pulse crops provides flavonoid compounds that will improve vascular function and glycemic control in individuals with Peripheral Artery Disease. Read more about this study
- Who is it for?
- Ages 34 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Mixed bean (higher amount) and Mixed beans (lower amount)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Dec 2013
- 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 34 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Participants, Acute Phase:
- Healthy volunteers, male or female, >33 years of age, age matched with PAD participants ± 7 years;
- BMI 18-30;
- Glycated hemoglobin < 6.5%;
- Fasting serum total cholesterol < 4 mmol/L and triglycerides < 2.5 mmol/L;
- Blood pressure < 140/90 mm Hg;
Show all 15Show fewer
- Ankle-brachial Index (ABI) >0.9;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
- Inclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):
- Male or female, > 40 years of age;
- Documented Peripheral Artery Disease including those with claudication as defined by an ankle brachial Index of ≤ 0.90; or asymptomatic carotid stenosis of > 50% or confirmed by imaging; or having had a previous intervention for Peripheral Artery Disease or carotid disease;
- Stable medication profile with no changes required for the past 3 months;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
Who cannot join
- Healthy Participants, Acute Phase:
- Currently smoking, or smoking within the last 6 months;
- Clinically diagnosed disease affecting the heart, liver, kidneys, lungs, gastrointestinal, endocrine or blood/immune systems that requires medical treatment;
- Taking any prescribed medication with the exception of birth control and hormone (estrogen) replacement therapy;
- Pregnancy;
- Amputation of upper or lower extremity on both sides;
Show all 19Show fewer
- History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods.
- Exclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):
- Currently smoking, or smoking within the last 6 months;
- Type 1 diabetes;
- Renal failure requiring dialysis;
- Acute cardiovascular event or medical illness within the past 3 months precluding study participation;
- Hormone (estrogen) replacement therapy;
- Amputation of upper or lower extremity on both sides;
- History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods;
- Currently participating in or having participated in a food study within the last 3 months unless randomized to a control group and consumed no study foods;
- High pulse consumption (greater or equal to 2 servings per week);
- Inability to adhere to a regular diet;
- Additional intake of pulses other than the requirements outlined in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pulse Varieties on Blood Vessel Function in Individuals With Peripheral Artery Disease (PAD)
Consumption of a diet containing pulse crops provides flavonoid compounds that will improve vascular function and glycemic control in individuals with Peripheral Artery Disease.
Read the detailed description
This is a single site, randomized, controlled, food intervention study designed to explore the effects of pulse types and varieties on blood vessel function in individuals with Peripheral Artery Disease.
Phase One(Acute): To identify relative potency of pulse types (beans,peas, lentils,and chickpeas) for vascular activity in healthy participants and participants with Peripheral Artery Disease. Healthy participants (10) and participants with Peripheral Artery Disease (10) will be asked to consume (in random order) one test food per in-person visit over 5 visits scheduled a minimum of 6 days apart. Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.
Phase Two(Chronic): Chronic 8-week study using mixed beans (pinto, kidney, black, and navy) to determine improvements in vascular function, cardiovascular risk factors, and glycemic control in participants with Peripheral Artery Disease (N=75, 25/group). Participants will be randomly assigned to one of the following three groups: i) foods containing 0.6 cup mixed beans/day consumed 5 days per week (total amount is 3 cups mixed beans per week); or, ii) foods containing 0.3 cup mixed beans/day for 5 days per week); or, iii) pulse-free foods (control) consumed 5 days/week. A total of 3 in-person visits for screening, baseline and final will be required during the 8-week study schedule. Assessments of vascular function, cognitive function, food dietary intake and preferences, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed at baseline and at 8 weeks.
Phase Three(Follow-Up: An 8-week follow-up assessment with a subset of participants (n=10/group, 3 groups) with Peripheral Artery Disease will be done at 2, 4, and at 8 weeks. Assessments of vascular function, cognitive function, food dietary intake, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed. These assessments will enable us to determine the length of time the benefits of the pulse consumption are retained.
- Conditions
- Peripheral Artery Disease
- Being tested
- control foods, Mixed bean (higher amount), Mixed beans (lower amount)
- Keywords
- Peripheral Artery Disease, Pulses, Beans, PAD
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control foodsOther
pulse-free control foods consumed daily, 5 days per week for 8 weeks
Mixed bean (higher amount)Other
0.6 cup of mixed beans consumed 5 days per week for 8 weeks
Mixed beans (lower amount)Other
0.3 cup of mixed beans consumed daily, 5 days per week for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mixed beans (higher amount) | Experimental | Participants may be randomized to foods containing 0.6 cup of mixed beans daily 5 times per week for 8 weeks Receives: Other: Mixed bean (higher amount) |
| Mixed beans (lower aomunt) | Experimental | Participants may be randomized to foods containing 0.3 cup of mixed beans daily, 5 times per week for 8 weeks. Receives: Other: Mixed beans (lower amount) |
| Control foods | Active comparator | pulse-free control foods consumed daily, 5 days per week for 8 weeks Receives: Other: control foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate individual pulse types and varieties in healthy participants and participants with Peripheral Artery Disease.
Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.
Measured: 5-week schedule
Secondary outcomes (3)
Evaluate the effects of mixed beans to determine improvements in vascular function
Ankle brachial index, blood vessel function and claudication onset/walking distance will be measured and compared at the pre/post consumption time points (time 0, Week 8) in participants receiving food items with the most potent pulse variety or the control food items, and in follow-up during the post consumption follow-up phase at Weeks 2,4, and 8. Results of blood samples will be assessed and compared at the same time points for lipids, glucose, insulin, glycated hemoglobin and select markers of vascular function.
Measured: 16 weeks
Analysis of dietary patterns and nutritional intake, compliance and tolerability before and after consumption of an 8-week diet of mixed beans
Dietary patterns and nutritional intake will be assessed at baseline and at Week 8. Participants will undergo an interview to assess compliance and tolerability at various time points (weeks 2, 5, and 8) throughout the 8-week feeding schedule.
Measured: 8 weeks
Evaluate the effects of mixed beans on cognitive function
Data from the cognitive assessments collected at time 0 and Week 8 of the feeding schedule, and in follow-up post consumption at Weeks 2, 4, and 8, will be analyzed according to the statistical guide and recommendations provided with these tests. The cognitive tests that will be administered are: Mini Mental State Examination, Hopkins Verbal Learning, Digit Symbol Similarities Test, and Digit Span.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Pulse Canada
- Responsible party
- Principal investigator, Dr. Peter Zahradka, University of Manitoba
- Investigators
- Peter C Zahradka, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382056
- Sponsor's protocol ID
- B2011:026
- Acronym
- PULV-2011
- Status last verified
- Feb 2014
- First submitted
- 22 Jun 2011
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dzau VJ, Braun-Dullaeus RC, Sedding DG. Vascular proliferation and atherosclerosis: new perspectives and therapeutic strategies. Nat Med. 2002 Nov;8(11):1249-56. doi: 10.1038/nm1102-1249. No abstract available.
PubMed 12411952Wilson PW, D'Agostino RB, Sullivan L, Parise H, Kannel WB. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002 Sep 9;162(16):1867-72. doi: 10.1001/archinte.162.16.1867.
PubMed 12196085Calkin AC, Allen TJ. Diabetes mellitus-associated atherosclerosis: mechanisms involved and potential for pharmacological invention. Am J Cardiovasc Drugs. 2006;6(1):15-40. doi: 10.2165/00129784-200606010-00003.
PubMed 16489846Juvenile Diabetes Research Foundation (2005) http://www jdrf org au/publications/factsheets/complications html
Li TY, Rana JS, Manson JE, Willett WC, Stampfer MJ, Colditz GA, Rexrode KM, Hu FB. Obesity as compared with physical activity in predicting risk of coronary heart disease in women. Circulation. 2006 Jan 31;113(4):499-506. doi: 10.1161/CIRCULATIONAHA.105.574087.
PubMed 16449729British Heart Foundation Statistics (2006) www heartstats org
Poels MM, van Oijen M, Mattace-Raso FU, Hofman A, Koudstaal PJ, Witteman JC, Breteler MM. Arterial stiffness, cognitive decline, and risk of dementia: the Rotterdam study. Stroke. 2007 Mar;38(3):888-92. doi: 10.1161/01.STR.0000257998.33768.87. Epub 2007 Feb 1.
PubMed 17272780Waldstein SR, Rice SC, Thayer JF, Najjar SS, Scuteri A, Zonderman AB. Pulse pressure and pulse wave velocity are related to cognitive decline in the Baltimore Longitudinal Study of Aging. Hypertension. 2008 Jan;51(1):99-104. doi: 10.1161/HYPERTENSIONAHA.107.093674. Epub 2007 Nov 19.
PubMed 18025297Houston DK, Stevens J, Cai J, Haines PS. Dairy, fruit, and vegetable intakes and functional limitations and disability in a biracial cohort: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 2005 Feb;81(2):515-22. doi: 10.1093/ajcn.81.2.515.
PubMed 15699243Bazzano LA, Serdula MK, Liu S. Dietary intake of fruits and vegetables and risk of cardiovascular disease. Curr Atheroscler Rep. 2003 Nov;5(6):492-9. doi: 10.1007/s11883-003-0040-z.
PubMed 14525683Hu FB, Willett WC. Optimal diets for prevention of coronary heart disease. JAMA. 2002 Nov 27;288(20):2569-78. doi: 10.1001/jama.288.20.2569.
PubMed 12444864Anderson JW, Major AW. Pulses and lipaemia, short- and long-term effect: potential in the prevention of cardiovascular disease. Br J Nutr. 2002 Dec;88 Suppl 3:S263-71. doi: 10.1079/BJN2002716.
PubMed 12498626Castro IA, Barroso LP, Sinnecker P. Functional foods for coronary heart disease risk reduction: a meta-analysis using a multivariate approach. Am J Clin Nutr. 2005 Jul;82(1):32-40. doi: 10.1093/ajcn.82.1.32.
PubMed 16002797Rowland I. Optimal nutrition: fibre and phytochemicals. Proc Nutr Soc. 1999 May;58(2):415-9. doi: 10.1017/s0029665199000543.
PubMed 10466185Gylling H, Miettinen TA. The effect of plant stanol- and sterol-enriched foods on lipid metabolism, serum lipids and coronary heart disease. Ann Clin Biochem. 2005 Jul;42(Pt 4):254-63. doi: 10.1258/0004563054255605.
PubMed 15989725
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulse Varieties on Blood Vessel Function in Individuals With Peripheral Artery Disease (PAD)
- ClinicalTrials.gov ID
- NCT01382056
- Acronym / sponsor ID
- PULV-2011 / B2011:026
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, Pulses, Beans, PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Pulse Canada
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jun 2011 (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.
Consumption of a diet containing pulse crops provides flavonoid compounds that will improve vascular function and glycemic control in individuals with Peripheral Artery Disease.
Detailed description
This is a single site, randomized, controlled, food intervention study designed to explore the effects of pulse types and varieties on blood vessel function in individuals with Peripheral Artery Disease.
Phase One(Acute): To identify relative potency of pulse types (beans,peas, lentils,and chickpeas) for vascular activity in healthy participants and participants with Peripheral Artery Disease. Healthy participants (10) and participants with Peripheral Artery Disease (10) will be asked to consume (in random order) one test food per in-person visit over 5 visits scheduled a minimum of 6 days apart. Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.
Phase Two(Chronic): Chronic 8-week study using mixed beans (pinto, kidney, black, and navy) to determine improvements in vascular function, cardiovascular risk factors, and glycemic control in participants with Peripheral Artery Disease (N=75, 25/group). Participants will be randomly assigned to one of the following three groups: i) foods containing 0.6 cup mixed beans/day consumed 5 days per week (total amount is 3 cups mixed beans per week); or, ii) foods containing 0.3 cup mixed beans/day for 5 days per week); or, iii) pulse-free foods (control) consumed 5 days/week. A total of 3 in-person visits for screening, baseline and final will be required during the 8-week study schedule. Assessments of vascular function, cognitive function, food dietary intake and preferences, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed at baseline and at 8 weeks.
Phase Three(Follow-Up: An 8-week follow-up assessment with a subset of participants (n=10/group, 3 groups) with Peripheral Artery Disease will be done at 2, 4, and at 8 weeks. Assessments of vascular function, cognitive function, food dietary intake, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed. These assessments will enable us to determine the length of time the benefits of the pulse consumption are retained.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mixed beans (higher amount) | Experimental | Other: Mixed bean (higher amount)Participants may be randomized to foods containing 0.6 cup of mixed beans daily 5 times per week for 8 weeks |
| Mixed beans (lower aomunt) | Experimental | Other: Mixed beans (lower amount)Participants may be randomized to foods containing 0.3 cup of mixed beans daily, 5 times per week for 8 weeks. |
| Control foods | Active comparator | Other: control foodspulse-free control foods consumed daily, 5 days per week for 8 weeks |
Who may qualify
- Ages
- 34 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy volunteers, male or female, >33 years of age, age matched with PAD participants ± 7 years;
- BMI 18-30;
- Glycated hemoglobin < 6.5%;
- Fasting serum total cholesterol < 4 mmol/L and triglycerides < 2.5 mmol/L;
- Blood pressure < 140/90 mm Hg;
Key exclusion criteria (19 listed)
- Currently smoking, or smoking within the last 6 months;
- Clinically diagnosed disease affecting the heart, liver, kidneys, lungs, gastrointestinal, endocrine or blood/immune systems that requires medical treatment;
- Taking any prescribed medication with the exception of birth control and hormone (estrogen) replacement therapy;
- Pregnancy;
- Amputation of upper or lower extremity on both sides;
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 |
|---|---|---|
| control foodspulse-free control foods consumed daily, 5 days per week for 8 weeks | Other | Control foods |
| Mixed bean (higher amount)0.6 cup of mixed beans consumed 5 days per week for 8 weeks | Other | Mixed beans (higher amount) |
| Mixed beans (lower amount)0.3 cup of mixed beans consumed daily, 5 days per week for 5 weeks | Other | Mixed beans (lower aomunt) |
Primary outcome
Evaluate individual pulse types and varieties in healthy participants and participants with Peripheral Artery Disease.
Time frame: 5-week schedule
Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.
3 secondary outcomes
Evaluate the effects of mixed beans to determine improvements in vascular function
Time frame: 16 weeks
Analysis of dietary patterns and nutritional intake, compliance and tolerability before and after consumption of an 8-week diet of mixed beans
Time frame: 8 weeks
Evaluate the effects of mixed beans on cognitive function
Time frame: 16 weeks
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 12 Feb 2014.
- Background: PubMed 12411952Dzau VJ, Braun-Dullaeus RC, Sedding DG. Vascular proliferation and atherosclerosis: new perspectives and therapeutic strategies. Nat Med. 2002 Nov;8(11):1249-56. doi: 10.1038/nm1102-1249. No abstract available.
- Background: PubMed 12196085Wilson PW, D'Agostino RB, Sullivan L, Parise H, Kannel WB. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002 Sep 9;162(16):1867-72. doi: 10.1001/archinte.162.16.1867.
- Background: PubMed 16489846Calkin AC, Allen TJ. Diabetes mellitus-associated atherosclerosis: mechanisms involved and potential for pharmacological invention. Am J Cardiovasc Drugs. 2006;6(1):15-40. doi: 10.2165/00129784-200606010-00003.
- BackgroundJuvenile Diabetes Research Foundation (2005) http://www jdrf org au/publications/factsheets/complications html
- Background: PubMed 16449729Li TY, Rana JS, Manson JE, Willett WC, Stampfer MJ, Colditz GA, Rexrode KM, Hu FB. Obesity as compared with physical activity in predicting risk of coronary heart disease in women. Circulation. 2006 Jan 31;113(4):499-506. doi: 10.1161/CIRCULATIONAHA.105.574087.
- BackgroundBritish Heart Foundation Statistics (2006) www heartstats org
- Background: PubMed 17272780Poels MM, van Oijen M, Mattace-Raso FU, Hofman A, Koudstaal PJ, Witteman JC, Breteler MM. Arterial stiffness, cognitive decline, and risk of dementia: the Rotterdam study. Stroke. 2007 Mar;38(3):888-92. doi: 10.1161/01.STR.0000257998.33768.87. Epub 2007 Feb 1.
- Background: PubMed 18025297Waldstein SR, Rice SC, Thayer JF, Najjar SS, Scuteri A, Zonderman AB. Pulse pressure and pulse wave velocity are related to cognitive decline in the Baltimore Longitudinal Study of Aging. Hypertension. 2008 Jan;51(1):99-104. doi: 10.1161/HYPERTENSIONAHA.107.093674. Epub 2007 Nov 19.
- Background: PubMed 15699243Houston DK, Stevens J, Cai J, Haines PS. Dairy, fruit, and vegetable intakes and functional limitations and disability in a biracial cohort: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 2005 Feb;81(2):515-22. doi: 10.1093/ajcn.81.2.515.
- Background: PubMed 14525683Bazzano LA, Serdula MK, Liu S. Dietary intake of fruits and vegetables and risk of cardiovascular disease. Curr Atheroscler Rep. 2003 Nov;5(6):492-9. doi: 10.1007/s11883-003-0040-z.
- Background: PubMed 12444864Hu FB, Willett WC. Optimal diets for prevention of coronary heart disease. JAMA. 2002 Nov 27;288(20):2569-78. doi: 10.1001/jama.288.20.2569.
- Background: PubMed 12498626Anderson JW, Major AW. Pulses and lipaemia, short- and long-term effect: potential in the prevention of cardiovascular disease. Br J Nutr. 2002 Dec;88 Suppl 3:S263-71. doi: 10.1079/BJN2002716.
- Website for Canadian Centre for Agri-food Research in Health and MedicineLink provided by the sponsor.
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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 C Zahradka, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed bean (higher amount) and Mixed beans (lower amount) in people with Peripheral Artery Disease, run by University of Manitoba at 1 site in Canada.
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 15 inclusion and 19 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 12 Feb 2014. 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 Canada. 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?
Evaluate individual pulse types and varieties in healthy participants and participants with Peripheral Artery Disease. (time frame: 5-week schedule). 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 NCT01382056, which also lists 42 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 12 Feb 2014.