A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and St… (NCT05539963) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States61 participantsStarted 2023-01-23
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. Osteomyelitis in any location other than the foot (i.e. excluding any bones located proximal to the foot)
✕. Osteomyelitis of the distal phalanx (toe tip) of the great toe or lesser toes
✕. Charcot foot or other deformities where the investigator believes adequate offloading is not possible
✕. Severe diabetic foot infection (grade 4) in accordance to IDSA/IWGDF criteria (Appendix 6)
What they're measuring
1
Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site
Timeframe: Week 24
2
Number of participants with no clinical need for further antibiotic therapy for infection at the index site
Timeframe: Week 24
3
Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site
✕. 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).
✕. Significant peripheral arterial disease:
✕. Hemoglobin A1c (HbA1c) \> 12%
✕. Contra-indication or inability to undergo an MRI scan