Outcomes of non-infected diabetic foot ulcers with/without antibiotics
Research type
Research Study
Full title
A prospective single blind randomised controlled study to compare the outcomes of patients with diabetes and clinically non-infected ischaemic and neuropathic foot ulcers treated with and without oral antibiotics
IRAS ID
47364
Sponsor organisation
King's College Hospital NHS Foundation Trust
Eudract number
2010-022518-16
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
In patients with diabetes, foot ulcers which appear initially clean and clinically uninfected can become very quickly infected and this can lead to delayed healing and the development of diabetic infective gangrene and amputation. Thus the overall objective of this study is to investigate whether antibiotic treatment of clinically clean diabetic foot ulcers in patients with diabetes can reduce the incidence of infection in these foot ulcers and thus accelerate healing of the ulcers and reduce the number of amputations.The study will recruit 166 patients: 83 patients will receive standard foot ulcer treatment with antibiotics (anbtibiotic group) and 83 patients will receive standard foot ulcer treatment without antibiotics(control group). Patients will be seen weekly. Their feet will be examined for clinical signs of infection. These signs include redness, swelling, pain, discharge from ulcer, malodour and the presence of pus. The percentage of patients whose ulcers heal will be compared between both groups. In addition, the percentage of patients who develop infection will also be compared. It is expected that fewer patients will develop infection if treated with antibiotics and their ulcers will heal faster. The benefit to health care is that fewer patients will need hospital admission and amputation.
REC name
London - City & East Research Ethics Committee
REC reference
11/LO/0281
Date of REC Opinion
13 Jul 2011
REC opinion
Further Information Favourable Opinion