Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/08/2010
Date assigned
19/08/2010
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Preece

ORCID ID

Contact details

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

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

Foot ulceration is one of the most common complications to affect people with diabetes. If not detected early, this condition can lead to full or partial amputation of the foot. Given the potential severity of foot ulceration, most diabetic patients are prescribed therapeutic shoes, known as diabetic shoes, which are designed to reduce the risk of skin breakdown. This breakdown often results from localised regions of high pressure under the foot and therefore, diabetic shoes are normally designed to reduce pressure during walking. This reduction is typically achieved using one or more footwear modifications, such as a specially designed sole unit, known as a rocker sole.

A rocker shoe has a number of unique design features. Specifically, the heel of the shoe is raised, the sole at the front of the shoe curved upwards and the flexibility of the outsole reduced. The combined effect of these features is to reduce pressure under the forefoot and toes. Previous research has shown that optimal pressure reduction requires individual adjustment of some of the design parameters, such as degree of curvature. However, at present there is no systematic approach for determining the best design for a rocker shoe for an individual diabetic patient, other than for them to try on a very large number of different shoes.

In this project we will first investigate the effect of four separate footwear design parameters which characterise a rocker shoe. We will then 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. It is envisaged that this research will lead to a system which can be used in shops and clinics to prescribe shoes for diabetic patients.

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 controlled trial

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

http://www.srht.nhs.uk/

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

Publication citations

Additional files

Editorial Notes