Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics (KADFUT)
Recruitment status was Not yet recruiting
The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved outcomes This is a single centre study in which patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without clinical signs of infection will be invited to take part and will express their willingness to take part in the study by signing a consent form.
- All patients will be treated and followed up in the DFC at King's College Hospital. Patients will be randomised into two groups: an antibiotic group and a control group.
- The antibiotic group will receive standard treatment along with antibiotics.
- The control group will have standard treatment alone.
- Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks.
- Patients will be removed from the study if they develop clinical signs of infection or if their ulcer heals prior to 20 weeks but will be followed up via routine practice for eventual outcomes
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
|Official Title:||A Prospective Single Blind Randomised Controlled Study to Compare the Outcomes of Patients With Diabetes and Clinically Non-infected Neuro-ischaemic and Neuropathic Foot Ulcers Treated With and Without Oral Antibiotics.|
- Time to healing of foot ulceration in each group [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- • Percentage of patients who will develop clinical signs of infection over a follow up period of 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- • Percentage of patients in each group that are healed at 20 weeks. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Active Antibiotic Group
Patients in the antibiotic group will remain on antibiotics until their foot ulcer heals or up to 20 weeks
A variety of antibiotics may be used, according to microbiology results, for up to 20 weeks
|No Intervention: Non antibiotic group|
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01418456
|Contact: Maureen Bates, MSc||0044 20 3299 3223 ext firstname.lastname@example.org|
|Principal Investigator:||Prof Mike E Edmonds, FRCP||king's College Hospital, London|