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: 10027
Conditions
Interventions
Trade Name: various
Product Name: amoxicillin trihydrate
Pharmaceutical Form: Capsule, hard
CAS Number: 61336-70-7
Other descriptive nam
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Time to healing of foot ulceration Reduction of the area of ulcer as indicated by serial tracings Percentage of patients who develop clinical signs of infection over a follow up period of 20 weeks Number of hospital admissions during the 20 weeks related to the foot ulcer Number of amputations during the 20 weeks Adverse effects of antibiotic treatment Rate of change of score in quality of life from baseline up to last treatment visit, healing or early termination using the SF-36 Rate of change of score in quality of life from baseline and up to last treatment visit, healing or early termination using the EQ-5D ; Primary end point(s): percentage of patients whose clinically non-infected foot ulcer will heal over a follow up period of 20 weeks, comparing those patients receiving antibiotics to those patients not receiving antibiotics. ;Timepoint(s) of evaluation of this end point: 20 weeks treatment;Main Objective: to determine whether there is a difference between active treatment with antibiotics and standard treatment alone | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Time to healing of foot ulceration 2) Absolute and relative ulcer area regression based on planimetry tracing 3) The percentage of patients in each group who will develop clinical signs of infection over period of 20 weeks 4) Number of hospital admissions up to week 20 5) Number of amputations up to week 20 6) Adverse effects of antibiotic treatment 7) Rate of change of score in quality of life from baseline up to last treatment visit, 8) A health economic evaluation to estimate the cost effectiveness of antibiotic treatment compared with standard treatment alone ; Timepoint(s) of evaluation of this end point: 1) healing of foot ulceration 2) healing of foot ulceration 3) 20 weeks 4) week 20 5) week 20 6) Adverse effects of antibiotic treatment 7) last treatment visit, 8) A health economic evaluation to estimate the cost effectiveness of antibiotic treatment compared with standard treatment alone | — |
Countries
United Kingdom
Contacts
Public ContactDiabetic Foot Clinic
King's College Hospital
Outcome results
None listed