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 of the Forefoot.

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the safety and between-group effect size of Stimulan-VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO) of the forefoot.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocomposites Ltd
• Collaborator: Parexel
• Treatments: Anti-Bacterial Agents

Criteria

Inclusion Criteria:

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

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

3. Participant who requires surgical debridement, but not to the extent that it requires amputation of the toe, metatarsal or ray

4. Participant who has confirmed presence of diabetic foot osteomyelitis (DFO) of the forefoot as evidenced by at least 3 out of 5 of the following:

1. Positive PTB (probe-to-bone) test

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

3. Plain X-ray highly suggestive of or most compatible with osteomyelitis

4. Ulcer present for greater than 30 days

5. Substantially elevated serum marker for inflammation

5. Participant is male or female

6. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance in from enrollment up to Week 52.

Exclusion Criteria:

1. Diabetic foot ulcer on the tip of toes or in any location other than the forefoot (proximal to the metatarsal neck)

2. Acute amputation site (< 30 days post-operatively)

3. Ulcers present for more than 12 months duration

4. Significant peripheral arterial disease: Ankle brachial index ≤ 0.7 mm Hg OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg

5. Any significant immunocompromising disease

6. Evidence of systemic infection/sepsis associated with osteomyelitis of the forefoot

7. Malignancy that might affect trial interpretation of outcomes or the participant's ability to complete the trial

8. Any other type of infection that would require ongoing systemic antibiotic therapy during trial enrollment

9. History of muscular disorders, such as myasthenia gravis or parkinsonism

10. Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia

11. Antibiotics to manage acute diabetic foot ulcer (DFU) infection within 24 hours prior to screening

12. Antibiotic therapy exceeding 10 days duration within two weeks prior to the washout period

13. Immunologically suppressed or has received systemic administration of corticosteroids at a dose of >10 mg prednisone (or corticosteroid equivalent) for more than 14 consecutive days within the 90 days prior to informed consent

14. Participant has a positive real-time reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has clinical signs and symptoms consistent with SARS-CoV-2 infection, or positive SARS-CoV-2 test result, had severe course of COVID-19 (extracorporeal membrane oxygenation [ECMO], mechanically ventilated).

15. Current or recent history (within the last 2 years) of active substance abuse

16. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (vancomycin), or aminoglycoside antibiotics (gentamicin)

17. Ulcers larger than 3.5 cm in diameter

18. Hemoglobin A1c (HbA1c) > 12%

19. DFI defined as severe (grade 4) by the Infectious Diseases Society of America (IDSA) /International Working Group on the Diabetic Foot criteria.

20. Moderate to severe reduction in renal function, defined as estimated glomerular filtration rate (eGFR) of < 44.0 ml/min/1.73 m2 and creatinine ≥ 3.0 mg/dL