SSHOES Diabetic Footwear

ISRCTN	ISRCTN14432407
DOI	https://doi.org/10.1186/ISRCTN14432407
Secondary identifying numbers	8619

Submission date: 19/08/2010
Registration date: 19/08/2010
Last edited: 06/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Preece
Scientific

University of Salford
Brian Blatchford Building
Salford
M6 6PU
United Kingdom

Study information

Study design	Multicentre non-randomised interventional trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multicentre non-randomised interventional trial of diabetic footwear in the prevention of foot ulceration
Study acronym	DRN 475
Study objectives	The aim of this study is to investigate the effect of four separate footwear design parameters which characterise a rocker shoe in order to develop a system which allows the best design, i.e. the one which minimises pressure, to be predicted from a simple biomechanical assessment of barefoot walking.
Ethics approval(s)	North West 8 Research Ethics committee - Greater Manchester East, 05/07/2010, ref: 10/H1013/32
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot
Intervention	The aim is to measure in-shoe pressures in many different types of footwear in a lab for a range of patients. With this information, we want to develop a system for prescribing bespoke footwear (i.e., footwear which minimises pressure). Patients do not undergo any treatment. Study Entry: registration only
Intervention type	Other
Primary outcome measure	Foot pressure after wearing the footwear for 5 minutes under laboratory conditions
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/06/2010
Completion date	01/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 100; UK sample size: 100
Key inclusion criteria	1. Have been diagnosed with diabetes at least 6 months previously (diabetic cohort only) 2. Be between 18 and 65 years, either sex 3. Be able to the University of Salford three times 4. Be able to walk for 2 - 5 minutes barefoot and in different shoes over 1.5 - 2 hours 5. Be able to understand both written and spoken English
Key exclusion criteria	1. Currently suffering with any form of ulceration or other foot condition resulting from diabetes 2. Have a major foot deformity sufficient to limit activity 3. Suffering any disorder with affects balance or mobility and/or a history of falls
Date of first enrolment	01/06/2010
Date of final enrolment	01/08/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Salford

Salford
M6 6PU
United Kingdom

Sponsor information

Salford Royal NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Dr Rachel Georgiou
NHS Salford Research and Development
Clinical Sciences Building
Stott Lane
Salford
M6 8HD
England
United Kingdom

Website	http://www.srht.nhs.uk/
"ROR"	https://ror.org/019j78370

Funders

Funder type

Government

European Union (EU) (Belgium) - Seventh Framework Programme (FP7)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/03/2017: No publications found in PubMed, verifying study status with principal investigator