Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/06/2004
Date assigned
14/06/2004
Last edited
10/12/2009
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 William Jeffcoate

ORCID ID

Contact details

FUTU
David Evans Research Centre
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 8405859
wjeffcoate@futu.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/74/03

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration.

Plain English Summary can be found at: http://www.hta.ac.uk/1357
Protocol available at: http://www.ncchta.org/protocols/200100740003.pdf
The trial is also listed on Nottingham Foot Ulcer Trials Unit website: http://www.futu.co.uk/research01.htm

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Diabetic Foot Ulcers

Intervention

Non-adherent (NA), Aquacel and Inadine dressings

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/06/2003

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients selected from those attending or newly referred to established expert multidisciplinary clinics for the management of diabetic foot ulcers in Blackburn, Hull, Ipswich, Newport, Nottingham and King's College Hospital, London

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

300

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/06/2003

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

FUTU
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19922726

Publication citations

  1. Results

    Jeffcoate WJ, Price PE, Phillips CJ, Game FL, Mudge E, Davies S, Amery CM, Edmonds ME, Gibby OM, Johnson AB, Jones GR, Masson E, Patmore JE, Price D, Rayman G, Harding KG, Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes., Health Technol Assess, 2009, 13, 54, 1-86, iii-iv, doi: 10.3310/hta13540.

Additional files

Editorial Notes