Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioMed Valley Discoveries, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
