None listed
Conditions
Brief summary
Diabetic foot bone infection (osteomyelitis) is among the most common causes of leg amputation and prolonged hospitalization among Australians. Early and prompt diagnosis and treatment of osteomyelitis is crucial to reducing hospital admissions and limb amputations. Currently the tests that are used to confirm osteomyelitis are either costly (MRI, bone scan), not readily available at the time of immediate need (MRI) or ineffective (x-ray) in differentiating foot osteomyelitis from soft tissue foot infections (cellulitis). To date no simple laboratory test shown to reliably differentiate the 2 common form of diabetic foot infections –cellulitis and osteomyelitis. Procalcitonin, a cheap, simple blood test for detecting and monitoring infections in other conditions is thought to be a useful test for diabetic foot infections. Blood level of procalcitonin has been reported to be markedly elevated in bone infections and lower levels in cellulitis. This study is designed to determine the role of procalcitonin in correctly distinguishing diabetic foot cellulitis from osteomyelitis and to assess levels that will be used to monitor response to treatment of both conditions.
Interventions
Diabetic foot cellulitis will be confirmed histologically through tissue biopsy/debridement (group 1 = 25). Serum procalcitonin levels will be determined using a commercially available enzyme-linked fluorescent assay and will be compared with the histology report as a diagnostic marker at onset of the study and at week 6 and 12 to monitor response to the usual care. Subjects will receive the treatment fortnightly comprising the following as usual care: After debridement, atraumatic dressing and
Diabetic foot cellulitis will be confirmed histologically through tissue biopsy/debridement (group 1 = 25). Serum procalcitonin levels will be determined using a commercially available enzyme-linked fluorescent assay and will be compared with the histology report as a diagnostic marker at onset of the study and at week 6 and 12 to monitor response to the usual care. Subjects will receive the treatment fortnightly comprising the following as usual care: After debridement, atraumatic dressing and nonadherent absorbent pad will be applied. Antibiotics will be administered based on microscopy, culture, and sensitivity results following deep wound swab and blood cultures. No additional treatment will be offered apart from the usual care.
Sponsors
James Cook University
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients meeting the following inclusion criteria will be eligible to enter the study: 1. Subjects with diabetic foot ulcer 2. Aged 18 years or over 3. Exclusion of other etiologies of foot ulcer.
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study: 1. Clinical infection at the studied ulcer site (bacterial and fungal) 2. Planned surgical intervention for the diabetic foot ulcer 3. Clinically significant lower-extremity ischemia (as defined by an ankle/brachial index of <0.65) 4. Significant medical conditions that would impair wound healing will also be excluded from the study. These conditions include hepatic, respiratory or cardiac failures, aplastic anemia, scleroderma and malignancy, treatment with immunosuppressive agents or steroids, myocardial infarcts, stroke, major surgery within 6 months of the study, or usage of tobacco 5. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis-related ulcers, calciphylaxis or dystrophic calcinosis cutis) 6. Active malignancy other than basal cell carcinoma as well as subjects with cancerous or pre-cancerous lesions in the ulcer area 7. Pregnancy 8. Inability to comply with study protocol
Outcome results
None listed