NCT02901847

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

September 12, 2016

Last Update Submit

February 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Distance walked before onset of intermittent claudication

    Distance walked before onset of intermittent claudication

    6 months

Study Arms (1)

Intervention

OTHER

PAD tailored care

Other: PAD tailored care

Interventions

PAD tailored care

Intervention

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations