Peripheral Arterial DiseasePodPADNCT02901847
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
A study testing PAD tailored care in people with Peripheral Arterial Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- PAD tailored care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Nov 2017
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient between the ages of 50-90 years,
- Patient attending for podiatry treatment
- diagnosis of PAD or is showing signs of symptoms of PAD
- wishes to take part in the study.
Who cannot join
- Anyone unable to give informed consent due to lack of mental capacity.
- Anyone who would be unable to participate in increased activity due to other co-morbidities
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. The podiatry clinic will be delivered from the Move More centre (NCSEM) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. Primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with the programme will also be assessed.
- Conditions
- Peripheral Arterial Disease
- Being tested
- PAD tailored care
- 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.
PAD tailored careOther
PAD tailored care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | PAD tailored care Receives: Other: PAD tailored care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked before onset of intermittent claudication
Distance walked before onset of intermittent claudication
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901847
- Sponsor's protocol ID
- STH19410
- Acronym
- PodPAD
- Status last verified
- Feb 2019
- First submitted
- 12 Sep 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
- ClinicalTrials.gov ID
- NCT02901847
- Acronym / sponsor ID
- PodPAD / STH19410
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 15 Sep 2016 (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.
The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. The podiatry clinic will be delivered from the Move More centre (NCSEM) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. Primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with the programme will also be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: PAD tailored carePAD tailored care |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patient between the ages of 50-90 years,
- Patient attending for podiatry treatment
- diagnosis of PAD or is showing signs of symptoms of PAD
- wishes to take part in the study.
Key exclusion criteria (2 listed)
- Anyone unable to give informed consent due to lack of mental capacity.
- Anyone who would be unable to participate in increased activity due to other co-morbidities
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 |
|---|---|---|
| PAD tailored carePAD tailored care | Other | Intervention |
Primary outcome
Distance walked before onset of intermittent claudication
Time frame: 6 months
Distance walked before onset of intermittent claudication
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 Feb 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAD tailored care in people with Peripheral Arterial Disease, run by Sheffield Teaching Hospitals NHS Foundation 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 4 inclusion and 2 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 Feb 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?
Distance walked before onset of intermittent claudication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2019.