A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis

Inclusion Criteria:

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

1. Participant must be ≥18 years of age inclusive, at the time of signing the informedconsent

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

3. Participant who has confirmed presence of DFO (to include all bones below the ankleincluding the talus and calcaneum) as evidenced by at least 3 out of 5 of thefollowing:

4. Positive PTB test

5. Presence of draining sinus presumed to be from underlying bone

6. Plain X-ray or MRI scan highly suggestive of or most compatible withosteomyelitis

7. Ulcer present for greater than 30 days

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

9. Participant who requires surgical debridement OR Participant requiring amputationand/or resection where residual osteomyelitis remains that necessitates furthersurgical debridement

10. 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

11. Subject or legal authorized representative able to provide, voluntary, signed anddated informed consent prior to any study related procedures

Exclusion criteria:

Participants are excluded from the trial if any of the following criteria apply:

1. Osteomyelitis in any location other than the foot (i.e. excluding any bones locatedproximal to the foot)

2. Osteomyelitis of the distal phalanx (toe tip) of the great toe or lesser toes

3. Charcot foot or other deformities where the investigator believes adequateoffloading is not possible

4. Severe diabetic foot infection (grade 4) in accordance to IDSA/IWGDF criteria (Appendix 6)

5. Moderate to severe reduction in renal function, defined as estimated glomerularfiltration rate (eGFR) of < 30.0 ml/min/1.73 m2 (Formula for calculating eGFR: 2021CKD-EPI Creatinine).

6. Significant peripheral arterial disease:

• Ankle brachial index ≤ 0.7 mm Hg OR

• toe pressure ≤ 40 mm Hg OR

• transcutaneous oximetry ≤ 40 mm Hg

7. Hemoglobin A1c (HbA1c) > 12%

8. Contra-indication or inability to undergo an MRI scan

9. Malignancy that might affect trial interpretation of outcomes or the participant'sability to complete the trial

10. Participant who is severely immunocompromised or has received high dosecorticosteroids (>10 mg prednisone (or corticosteroid equivalent) for more than 14consecutive days within the 90 days prior to informed consent)

11. Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant riskfor developing hypercalcemia (i.e., Hyperparathyroidism)

12. Patients with active COVID-19 will be excluded from enrollment until they are ableto undergo the surgical procedure

13. Current or recent history (within last 2 years) of active substance abuse (e.g.recreational drugs, narcotics, or alcohol) that, in the judgment of theinvestigator, may compromise the ability of the trial participant to adhere to thetrial conduct and procedures

14. Previous history of adverse incidents, allergy or contra indications (e.g. MyathesiaGravis) to any component of the investigational product, such as calcium sulfate,glycopeptide antibiotics (vancomycin), or aminoglycoside antibiotics (gentamicin)

15. Concurrent involvement in a trial of another investigational product

16. The Investigator believes trial participation may compromise safety of theparticipant or the results of the trial