∙ Participants are eligible to be included in the trial only if all of the following criteria apply:

• Participant must be ≥18 years of age inclusive, at the time of signing the informed consent

• Participant has a current diagnosis and is being treated for diabetes mellitus, type 1 or type 2

• Participant who has confirmed presence of DFO (to include all bones below the ankle including the talus and calcaneum) as evidenced by at least 3 out of 5 of the following:

‣ Positive PTB test

⁃ Presence of draining sinus presumed to be from underlying bone

⁃ Plain X-ray or MRI scan highly suggestive of or most compatible with osteomyelitis

⁃ Ulcer present for greater than 30 days

⁃ Substantially elevated serum marker for inflammation (e.g. ESR \>70 mm/hr and C-reactive protein \>14mg/L or at least 40% higher than upper limits of normal value used at the investigational site)

• Participant who requires surgical debridement OR Participant requiring amputation and/or resection where residual osteomyelitis remains that necessitates further surgical debridement

• All genders are eligible to participate if they are not pregnant, not breastfeeding, are not of childbearing potential or they agree to follow contraceptive guidance

• Subject or legal authorized representative able to provide, voluntary, signed and dated informed consent prior to any study related procedures