Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 informed consent 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 ankle including the talus and calcaneum) as evidenced by at least 3 out of 5 of the following: 1. Positive PTB test 2. Presence of draining sinus presumed to be from underlying bone 3. Plain X-ray or MRI scan highly suggestive of or most compatible with osteomyelitis 4. Ulcer present for greater than 30 days 5. 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) 4. Participant who requires surgical debridement OR Participant requiring amputation and/or resection where residual osteomyelitis remains that necessitates further surgical debridement 5. 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 6. Subject or legal authorized representative able to provide, voluntary, signed and dated 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 located proximal 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 adequate offloading 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 glomerular filtration rate (eGFR) of < 30.0 ml/min/1.73 m2 (Formula for calculating eGFR: 2021 CKD-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's ability to complete the trial 10. Participant who is severely immunocompromised or has received high dose corticosteroids (>10 mg prednisone (or corticosteroid equivalent) for more than 14 consecutive days within the 90 days prior to informed consent) 11. Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism) 12. Patients with active COVID-19 will be excluded from enrollment until they are able to 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 the investigator, may compromise the ability of the trial participant to adhere to the trial conduct and procedures 14. Previous history of adverse incidents, allergy or contra indications (e.g. Myathesia Gravis) 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 the participant or the results of the trial

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
STIMULAN VG
Participants will receive STIMULAN VG on Day 1 following surgical debridement. Systemic antibiotics for 3 days ± 2 days following the debridement surgery.
  • Drug: STIMULAN VG
    Participants will receive STIMULAN VG via implantation during debridement surgery on Day 1.
  • Drug: Systemic Antibiotics
    Participants will receive Antibiotics per site-specific requirements.
Active Comparator
Standard of Care
Participants will receive Systemic antibiotics for 4-6 weeks following the debridement surgery.
  • Drug: Systemic Antibiotics
    Participants will receive Antibiotics per site-specific requirements.

Recruiting Locations

Titan Clinical Research
Mesa, Arizona 85202
Contact:
602-471-5245

Axsendo Clinical Research
Phoenix, Arizona 85024
Contact:
Ryleigh Alfonso
602-730-9500
ryleigh.alfonso@axsendoclinical.com

Perseverance Research Center, LLC
Scottsdale, Arizona 85253
Contact:
480-471-6132

Advanced Footcare LLC
Scottsdale, Arizona 85260
Contact:
Kanchan Verandani
419-208-4421
kverandani892@gmail.com

NEA Baptist Clinic
Jonesboro, Arkansas 72405
Contact:
870-936-8465

Viable Clinical Research
Henderson, Nevada 89014
Contact:
702-544-9034

Equitable Health Partners - NJ
Mountainside, New Jersey 07092
Contact:
856-906-8185

Mount Sinai West
New York, New York 10019
Contact:
212-523-8195

UNC School Medicine
Chapel Hill, North Carolina 27599
Contact:
Kari Walls
984-974-3777
kawalls@email.unc.edu

Seaside Clinical Research Institute
Wilmington, North Carolina 28412
Contact:
Dr Hoff
910-408-5746

More Details

NCT ID
NCT05539963
Status
Recruiting
Sponsor
Biocomposites Ltd

Study Contact

Keira Watts, Clinical Project Manager
+44 (0) 1782 338 580
clinicaltrials@biocomposites.com

Detailed Description

This trial is an open-label, multi-center, randomized, controlled feasibility trial. All participants will undergo surgical debridement and receive either STIMULAN VG and an abbreviated course of systemic antibiotic therapy (3 days ±2 days) or a full course (4-6 weeks) of systemic antibiotic therapy. The total duration of study is Approximately 55 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.