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 designMulticentre non-randomised interventional trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA multicentre non-randomised interventional trial of diabetic footwear in the prevention of foot ulceration
Study acronymDRN 475
Study objectivesThe 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) studiedTopic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot
InterventionThe 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 typeOther
Primary outcome measureFoot pressure after wearing the footwear for 5 minutes under laboratory conditions
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/06/2010
Completion date01/08/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 100; UK sample size: 100
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2010
Date of final enrolment01/08/2012

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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