SSHOES Diabetic Footwear
| ISRCTN | ISRCTN14432407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14432407 |
| Protocol serial number | 8619 |
| Sponsor | Salford Royal NHS Foundation Trust (UK) |
| Funder | European Union (EU) (Belgium) - Seventh Framework Programme (FP7) |
- 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
Scientific
University of Salford
Brian Blatchford Building
Salford
M6 6PU
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre non-randomised interventional trial |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
Foot pressure after wearing the footwear for 5 minutes under laboratory conditions |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Salford
Salford
M6 6PU
United Kingdom
M6 6PU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/03/2017: No publications found in PubMed, verifying study status with principal investigator
