Clinical trial NCT05539963: 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
Official title: A Multi-center, Randomized, Controlled Feasibility Trial of STIMULAN VG and Debridement With an Abbreviated Course of Systemic Antibiotics to Debridement and a Full Course of Systemic Antibiotics for the Treatment of Diabetic Foot Osteomyelitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Foot Osteomyelitis
Keywords: feasibility
between-group effect size
surgical debridement
systemic antibiotic
Lead sponsor: Biocomposites Ltd
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2022-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site
timeFrame: Week 24
measure: Number of participants with no clinical need for further antibiotic therapy for infection at the index site
timeFrame: Week 24
measure: Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site
timeFrame: Week 24
Secondary outcomes:
measure: Ulcer healing per the University of Texas (UT) Staging System for Diabetic Foot Ulcers
timeFrame: Week 12
measure: Number of participants with occurrence of reinfection at the index site
timeFrame: Week 52
measure: Number of participants with no clinical need for further antibiotic therapy for infection at the index site
timeFrame: Week 52
measure: Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site
timeFrame: Week 52
measure: Relative change from baseline in Cardiff Wound Impact Schedule (CWIS) quality of life assessment
timeFrame: Week 24
measure: Number of participants with adverse events
timeFrame: Week 52
measure: Number of participants discontinuing therapy prematurely due to a treatment related event
timeFrame: Week 52
measure: Number of hospitalizations/re-hospitalizations as a result of treatment for osteomyelitis or ulceration at the index site
timeFrame: Week 52
measure: Number of participants undergoing amputation at the index site
timeFrame: Week 52
measure: Number of systemic antibiotic free days since trial surgery
timeFrame: Week 52
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Titan Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Axsendo Clinical Research
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Advanced Footcare LLC
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Henderson
country: United States
facility: Viable Clinical Research
state: Nevada
city: Mountainside
country: United States
facility: Equitable Health Partners - NJ
state: New Jersey
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: Chapel Hill
country: United States
facility: UNC School Medicine
state: North Carolina
city: Wilmington
country: United States
facility: Seaside Clinical Research Institute
state: North Carolina
Study officials:
References: