A trial to see if antibiotics can prevent infection in people with diabetes with foot ulcers

Phase 1

• Conditions: foot ulcers with no clinical signs of infection in patients with diabetes.; MedDRA version: 14.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2010-022518-16-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-11
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 166

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.
The most appropriate antibiotic and alternative IMP (section 3.2) are
contraindicated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified