A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

NCT06283979 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 199723
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

Conditions

Pressure Ulcer, Stage IV; Osteomyelitis

Keywords

between-group effect size; surgical debridement; ulcer bursectomy; systemic antibiotics

Outcome Measures

Primary Outcomes (1)

• Individual patient success and findings at the 8 week follow-up visit

  An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.

  8 week

Study Arms (2)

Interventional STIMULAN VG

EXPERIMENTAL

Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity. Flap/primary closure. Peri-operative antibiotics.

Combination Product: STIMULAN VG; Procedure: Standard of Care

Standard of Care (SoC)

ACTIVE COMPARATOR

Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.

Procedure: Standard of Care

Interventions

STIMULAN VG COMBINATION_PRODUCT

Insertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.

Interventional STIMULAN VG

Standard of Care PROCEDURE

Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.

Interventional STIMULAN VG; Standard of Care (SoC)

Eligibility Criteria

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

In order to be eligible to participate in this study, subjects must meet all of the following criteria: 1. Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure. 2. Operative candidate for flap surgery or primary closure. 3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan. 4. Adults ≥ 18 years in age at the time of treatment. 5. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures. 6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures. Subjects who meet any of the following criteria will be excluded from participating in this study: 1. Reasons contributing to pressure ulcer cannot be addressed. 2. Severe immunological compromised patients as determined by the clinician. 3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement. 4. Patients presenting with head pressure ulcers. 5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety/recovery or ability to follow the trial procedures. 6. Current smoker. 7. Diabetic patient with Hba1C level above 9. 8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin). 9. Concurrent involvement in a study of another investigational product. 10. Pregnant or planning to become pregnant during study period. 11. Flexion contractures where patient cannot passively get full extension. 12. Uncontrolled muscle spasms. 13. Unable to comply with bedrest restriction or offloading requirements 14. Unable to provide consent. 15. Fecal or urinary incontinence with contamination of the wound. 16. Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg \* 17. Investigator considers the participant to be clinically malnourished. 18. Any conditions with known hypercalcemia (\> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism). 19. Investigator believes trial participation may compromise safety of the participant or trial results. * Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Biocomposites Ltd: lead
• MCRA: collaborator

Study Sites (9)

Advanced Foot Care, LLC

Phoenix, Arizona, 85032, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Missouri Orthopaedic Institute

Columbia, Missouri, 65201, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

RECRUITING

NYU Langone Hospital - Long Island Clinical Research Center

Mineola, New York, 11501, United States

RECRUITING

University of Pittsburgh, McGowan Institute for Regenerative Medicine

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer; Osteomyelitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Keira Watts, Clinical Research Director

CONTACT

+44 (0) 1782 338 580; clinicaltrials@biocomposites.com

Daniel Roberts

CONTACT

droberts@mcra.com

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: February 21, 2024
• First Posted: February 28, 2024
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)