Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
15/10/2014
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

Prof P G Wiles

ORCID ID

Contact details

Department of General Medicine
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0155184582

Study information

Scientific title

Acronym

Study hypothesis

Is the application of semi-rigid coated slippers using soft cast materials, safe and effective in healing ulcers in vulnerable, at risk, ischaemic feet in people with diabetes?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetic foot

Intervention

Slipper vs standard treatment

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Ulcer size and patient-focused outcomes

Secondary outcome measures

Patient satisfaction and quality of life

Overall trial start date

01/10/2006

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with diabetic ischaemic foot

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2006

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of General Medicine
Manchester
M8 5RB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Pennine Acute Hospitals NHS Trust (UK)

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