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Evaluation of toe pressure PPG measurement in diabetics with PAD

Short Study Title:
Evaluation of toe pressure PPG measurement in diabetics with PAD

Protocol No.
1

Description:
Evaluation of toe pressure PPG measurement as a method for assessing peripheral arterial disease improvement in diabetics with claudication following a 6 week exercise programme.

REC reference:
15/EE/0428

Sponsor(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

IRAS Project ID:
174255

Funder(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Geographical Scope:
Single Centre

Disease Area:
Peripheral arterial disease in patients with diabetes

Sample Size:
18

Study Type:
Observational

Study Design:
Non randomised

Estimated Closure Date:

Current Status:
Closed

Inclusion Criteria:
Participants who have signed up for the 6 week clinically supervised exercise programme offered within the Trust (both diabetic and non-diabetic).
Able and willing to undergo measurements at baseline and 6 weeks.
Able and willing to provide informed consent for the research.
Aged 18 years or older.

Exclusion Criteria:
Patients with any major issues that could significantly affect the results will be excluded. For example, patients with injuries or disorders that could skew their interpretation of claudication pain, e.g. sciatica.
Unable or unwilling to undertake the 6 week supervised exercise programme.
Unable or unwilling to undergo measurements at baseline and 6 weeks.
Unable or unwilling to provide written informed consent.
Aged under 18 years.

Chief Investigator:
Crispian Oates
Freeman Hospital
Newcastle

Key Co-Investigator(s):
Janine McNeill
Trainee vascular scientist
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
Dorset BH7 7DW

Location(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust