Comparing outcomes of oral versus intravenous antibiotic therapy for the treatment of the diabetic foot wound complicated by osteomyelitis
- Conditions
- Diabetic foot osteomyelitisInfection - Other infectious diseasesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12612000833864
- Lead Sponsor
- Southern Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 7
18 years or older; currently treated patient at Southern Health; Diagnosis of Type I or Type II diabetes mellitus; Diabetic foot osteomyelitis confirmed on MRI, Plain X-ray and clinical signs and symptoms; adequate macrovascular blood supply; adequate debridement of infected tissue; known pathogen(s); suitable for oral and intravenous antibiotic therapy; two weeks or less of IV antibiotic therapy for diabetic foot osteomyelitis at baseline.
Females that are pregnant or breastfeeding; sepsis at presentation; positive blood culture within 14 days of presentation; inadequate macrovascular supply; amputation of infected limb planned/performed; pathogen unknown; known pathogens resistant to appropriate oral and/or IV antibiotics included in treatement strategy; more than 14 days of IV antibiotic therapy prior to baseline; allergy or other absolute contraindication to the oral and/or IV antibiotics listed in treatment strategy; implant or prosthetic device in infected limb; has another condition that requires treatment with antibiotics for greater than one week prior to baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resolution of osteomyelitis as evaluated by the absence of infection and the infection severity grading following examination of clinical signs and symptoms. <br>Criteria for determining presence of infection will be based on the current recommendations from the Infectious Diseases Society of America and the current consensus document from the International Working Group on the Diabetic Foot.<br>Grading of infection severity is based on Infectious Diseases Society of America - International Working Group on the Diabetic Foot validated criteria.[4 weeks post treatment];Resolution of osteomyelitis as evaluated by plain X-ray[4 weeks post treatment]
- Secondary Outcome Measures
Name Time Method Percent reduction in wound size[Baseline, Week 1 - 6 (treatment period), Week 10 (4 weeks post treatment), Week 14 (8 weeks post treatment) and Week 18 (12 weeks post treatment)];The clinical utility of using the EuroQol 5D (EQ-5D) for quality of life assessment[Baseline, Week 4, Week 18 (12 weeks post treatment)];Reaching 30 minimum number of participants in a 6 month period[Monitored continuously throughout the study];Completion of study in at least 90% of all recruited participants[Monitored continuously throughout the study];Analysis of costs of oral antibiotic therapy compared to costs of intravenous therapy[At completion of study]