EUCTR2010-022518-16-GB
Active, not recruiting
Phase 1
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 - Outcomes of non-infected diabetic foot ulcers with/without antibiotics
Drugsvarious
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- King's College Hospital NHS Foundation Trust
- Enrollment
- 166
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female age between 18\-85 years inclusive
- •Has been diagnosed with Type 1 or Type 2 diabetes
- •Must be able to speak and understand English and be able to provide meaningful written informed consent.
- •Present with one or more diabetic foot ulcer/s on or below malleoli with no clinical signs of infection as indicated by the Infectious Disease Society of America/International Working Group on the Diabetic Foot Guideline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 166
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 166
Exclusion Criteria
- •Patients should not have been taking antibiotics for at least one week prior to entry into the study
- •Female patients who are pregnant or breast feeding.
- •Any known intolerance or allergy or reported adverse reaction to any antibiotics with the exception of penicillin allergies.
- •Known osteomyelitis, as indicated by it being possible to probe to bone at the base of the ulcer.
- •Ulceration caused primarily by a disease other than diabetes.
- •Any other serious disease likely to compromise the outcome of the trial.
- •Evidence of critical renal disease (creatinine \>300µmol/L).
- •Patients taking immunosuppressants or any other preparation which may interfere with healing.
- •Participation in another clinical trial in the previous 28 days
- •Patients with foot ulcers which have clinical signs of infection.
Outcomes
Primary Outcomes
Not specified
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