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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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