[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection

Inclusion Criteria:

1. Male and female patients >/= 18 years on the day of signing consent.

2. A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c>6.5% or
receipt of antidiabetic medication at time of enrollment.

3. Ability to provide informed consent

4. An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and
sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with
PEDIS grade 4 infections may be included if they are sufficiently stable.

5. For females of childbearing potential, a negative urine pregnancy test on the day of
dosing.

6. For females of childbearing potential, a willingness to use 2 methods of
contraception for 30 days after receiving [124I]FIAU.

7. Ability to return for all study assessments.

8. Clinically euthyroid, or on stable thyroid replacement therapy.

Exclusion Criteria:

1. Patients who ar unable to comply with study requirements.

2. Indication, in the opinion of the principal Investigator for urgent surgery that
would preclude the time needed for PET-CT scanning, or clinical instability that
precludes PET-CT scanning.

3. History of an inherited mitochondrial disorder (eg. Leber's hereditary neuropathy,
neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic
gastrointestinal encephalopathy [MNGIE], myocolonic epilepsy with ragged red fibers
[MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and
stroke-like syndrome [MELAS])

4. Alanine aminotransferase (ALT)>5x Upper Limit of Normal (ULN) OR aspartate
aminotransferase (AST) >5x ULN.

5. Body mass that exceeds the rating of the CT table.

6. Hypersensitivity to iodine.

7. Pregnant or breast-feeding.

8. Any condition that would put the patient at unreasonable risk in the opinion of the
Investigator.