Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
14/03/2014
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 ME Edmonds

ORCID ID

Contact details

Diabetic Foot Clinic
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 7346 3223

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0116140783

Study information

Scientific title

Acronym

Study hypothesis

1. The primary objective is to test whether modern dressings are more clinical effective than traditional dressings in the treatment of diabetes related foot ulcers. The dressings to be compared will be: a simple, traditional non-adherent preparation (N-A), a widely used modern antiseptic preparation (Inadine), and a new hydrofibre preparation of higher unit cost (Aquacel). All three dressings are widely used in clinical practices in the UK.
2. To investigate changes in ulcer size, condition and reoccurrence during the study period associated with each dressing.
3. To determine the cost-effectiveness associated with each of the three dressings.
4. To assess the patients' mood, satisfaction and quality of life associated with each of the three dressings.
5. To investigate the patient and carer contribution to care in terms of involvement with self-care, and to gain qualitative insights into the patient experience with each of the dressing interventions.

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

Nutritional, Metabolic, Endocrine: Diabetic foot

Intervention

The dressings to be compared will be: a simple, traditional non-adherent preparation (N-A), a widely used modern antiseptic preparation (Inadine) and a new hydrofibre preparation of higher unit cost (Aquacel).

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

01/10/2003

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

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

01/10/2003

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetic Foot Clinic
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Kings College Hospital NHS Trust R&D Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D support funding

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