Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8619
Study information
Scientific title
A multicentre non-randomised interventional trial of diabetic footwear in the prevention of foot ulceration
Acronym
DRN 475
Study hypothesis
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
North West 8 Research Ethics committee - Greater Manchester East, 05/07/2010, ref: 10/H1013/32
Study design
Multicentre non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Foot pressure after wearing the footwear for 5 minutes under laboratory conditions
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2010
Overall trial end date
01/08/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 100; UK sample size: 100
Participant 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
Recruitment start date
01/06/2010
Recruitment end date
01/08/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Salford
Salford
M6 6PU
United Kingdom
Sponsor information
Organisation
Salford Royal NHS Foundation Trust (UK)
Sponsor details
c/o Dr Rachel Georgiou
NHS Salford Research and Development
Clinical Sciences Building
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
European Union (EU) (Belgium) - Seventh Framework Programme (FP7)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary