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

NCT05539963 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 254915
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 10

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).

Conditions

Diabetic Foot Osteomyelitis

Keywords

feasibility; between-group effect size; surgical debridement; systemic antibiotic

Outcome Measures

Primary Outcomes (3)

• Number of participants with confirmed absence of clinical signs of osteomyelitis or surgical infection at the index site

  Confirmed absence of clinical signs of osteomyelitis or surgical site infection at the index site will be evidenced by Negative Probe to Bone Test (PTB), absence of draining sinus presumed to be from underlying bone and MRI scan at Week 24.

  Week 24

• Number of participants with no clinical need for further antibiotic therapy for infection at the index site

  Need for further antibiotic therapy for infection at the index site will be assessed at Week 24.

  Week 24

• Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site

  Need for further additional surgical procedure or debridement to treat infection at the index site will be assessed at Week 24.

  Week 24

Secondary Outcomes (10)

• Ulcer healing per the University of Texas (UT) Staging System for Diabetic Foot Ulcers

  Week 12

• Number of participants with occurrence of reinfection at the index site

  Week 52

• Number of participants with no clinical need for further antibiotic therapy for infection at the index site

  Week 52

• Number of participants with no clinical need for further additional surgical procedure or debridement to treat infection at the index site

  Week 52

• Relative change from baseline in Cardiff Wound Impact Schedule (CWIS) quality of life assessment

  Week 24

Study Arms (2)

STIMULAN VG

EXPERIMENTAL

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; Drug: Systemic Antibiotics

Standard of Care

ACTIVE COMPARATOR

Participants will receive Systemic antibiotics for 4-6 weeks following the debridement surgery.

Drug: Systemic Antibiotics

Interventions

STIMULAN VG DRUG

Participants will receive STIMULAN VG via implantation during debridement surgery on Day 1.

STIMULAN VG

Systemic Antibiotics DRUG

Participants will receive Antibiotics per site-specific requirements.

STIMULAN VG; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the trial only if all of the following criteria apply:
• 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)
• Participant who requires surgical debridement OR Participant requiring amputation and/or resection where residual osteomyelitis remains that necessitates further surgical debridement
• 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
• Subject or legal authorized representative able to provide, voluntary, signed and dated informed consent prior to any study related procedures

You may not qualify if:

• Participants are excluded from the trial if any of the following criteria apply:
• 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)
• 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:
• Ankle brachial index ≤ 0.7 mm Hg OR
• toe pressure ≤ 40 mm Hg OR
• transcutaneous oximetry ≤ 40 mm Hg
• Hemoglobin A1c (HbA1c) \> 12%
• Contra-indication or inability to undergo an MRI scan
• Malignancy that might affect trial interpretation of outcomes or the participant's ability to complete the trial
• 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)
• Any conditions with known hypercalcemia (\> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism)

Sponsors & Collaborators

• Biocomposites Ltd: lead
• MCRA: collaborator

Study Sites (10)

Titan Clinical Research

Mesa, Arizona, 85202, United States

Location

Axsendo Clinical Research

Phoenix, Arizona, 85024, United States

Location

Perseverance Research Center, LLC

Scottsdale, Arizona, 85253, United States

Location

Advanced Footcare LLC

Scottsdale, Arizona, 85260, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72405, United States

Location

Viable Clinical Research

Henderson, Nevada, 89014, United States

Location

Equitable Health Partners - NJ

Mountainside, New Jersey, 07092, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

UNC School Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Seaside Clinical Research Institute

Wilmington, North Carolina, 28412, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: January 23, 2023
• Primary Completion: June 20, 2025
• Study Completion: December 30, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)