Infected bone in the foot of persons with diabetes. Osteomyelitis of the diabetic foot
Conditions
Interventions
All subjects with suspected DFO will undergo plain X-rays, MRI and/or
FDG-PET/CT, deep wound tissue biopsy and percutaneous bone biopsy, before
initiation of empiric antibiotic therapy as part of st
the other half
(up to10) will undergo these procedures at 6 weeks after initiation of
antibiotic therapy. All subjects will be treated with guided antibiotic therapy
for 6 weeks.
Subjects will be
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Type 1 or 2 diabetes mellitus 2. Infected wound, that extends at least to the anatomical plane of the fascia, muscle, tendon or bone (IWGDF infection grade 3 of 4). 3. Osteomyelitis, defined as presence of such a wound with one of the following criteria: - Positive probe to bone test - Abnormalities on plain X-ray suggestive for osteomyelitis - Erythrocyte sedimentation rate >=70 mm/hr (with no other explanation for the elevated sedimentation rate than osteomyelitis) - Signs of osteomyelitis on MRI and/ or FDG-PET/CT scan - Positive culture, PCR, or histology of a bone biopsy 4 Able and willing to comply with the research protocol
Exclusion criteria
Exclusion criteria: - Likely to undergo complete surgical bone debridement or amputation. Subjects that (are likely to) undergo surgery within 72 hours after enrollment for other reasons, e.g. abscesses, compartment syndrome, partial bone resection) are not excluded. - Presence of uncorrectable critical limb ischemia. Subjects that (are likely to) undergo surgical or percutaneous revascularization are not excluded - Severely immunocompromised (as judged by the treating physician, e.g. neutropenia due to chemotherapy, hiv infection with CD4-count of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint The primary outcome measure will be remission of osteomyelitis at 12 months. Ulcer healing will be defined as complete epithelialization for more than 28 consecutive days. Remission of osteomyelitis is defined as complete wound healing at the original ulcer site, and absence of local or systemic signs of inflammation without relapse at the original site of osteomyelitis, and/or stabilization or improvement of radiologic abnormalities. A relapse is defined as recurrence of signs of inflammation and failure of initial therapy (the need to (re)start or prolongation of antibiotic therapy for the original infection location) after 6 weeks of systemic antibiotic therapy or to perform surgery to control the source of infection. Subjects in remission will not have undergone surgical bone debridement or amputation or broadening of spectrum of directed antibiotic therapy or antibiotic therapy targeted at the other diagnostic modality (bone or soft tissue sample) than which the subject was originally assigned to. An infection relapse is the presence of signs of inflammation at the original anatomical ulcer location with or without a new or persisting ulcer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints Secondary outcome measures will be assessed at the end of treatment, and at 6 and 12 months after enrolment by both the treating physician and an independent investigator. The individual assessments make it possible to compare their findings: - Ulcer healing, defined as complete epithelialization for more than 28 consecutive days. - Time to ulcer healing (in days). - Change in ulcer size. Recorded ulcer size will be length, width and depth. Depth will be measured in millimetres and in anatomical plane (e.g. skin or bone). Ulcer characteristics will be described using the infection classification of the International Working Group on the Diabetic Foot.[26] - Ulcer relapse: ulcer at same anatomical location as the index ulcer after initial ulcer healing - New ulcer: Ulcer at other anatomical site of the foot or on the contralateral foot. - Presence of signs of inflammation (defined as redness, warmth, swelling, pain, and purulent exudate, recorded by the treating physician) - Performed surgical interventions including minor amputation (distal to the malleoli), major amputation (proximal to the malleoli), incision and drainage (e.g. for abscesses) and bone debridement. - Adverse events (grade 3 or higher) of antimicrobial treatment. Adverse events of antimicrobial therapy will be recorded if these are noted in the subject*s medical records, and if these possible adverse effects led to dose adjustment or cessation of the antibiotic. Examples of adverse effects are: hepatotoxicity, acute kidney injury, skin rash, or Clostridium difficile associated diarrhoea. - Duration of antimicrobial treatment (in days). - Quality of life measured with validated questionnaires (PAID-NL, SF-36, USER-P). Short Form (SF-36) is a set of generic and easily administered quality-of-life measures in adults. Problem Areas In Diabetes (PAID-NL) is a 20-item measure of diabetes-related distress for use in adults with diabetes. | — |
Countries
Netherlands
Outcome results
None listed