Randomised controlled trial of the use of three dressing regimens in the management of chronic ulcers of the foot in diabetes.

ISRCTN ISRCTN52817488
DOI https://doi.org/10.1186/ISRCTN52817488
Secondary identifying numbers N0116140783
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
14/03/2014
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 ME Edmonds
Scientific

Diabetic Foot Clinic
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Phone +44 (0)20 7346 3223

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, Metabolic, Endocrine: Diabetic foot
InterventionThe 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/2003
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2003
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Diabetic Foot Clinic
London
SE5 9RS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

NHS R&D support funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan