Comparing STIMULAN VG to standard care for treating severe pressure ulcers with infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and effectiveness of STIMULAN VG combined with surgical debridement and systemic antibiotics against standard care, which includes debridement and antibiotics alone, for patients with stage IV pressure ulcers complicated by osteomyelitis. It is an open-label, multi-center, randomized controlled phase II trial, enrolling adults who require surgical intervention for their ulcers. The study aims to determine the between-group effect size and tolerability of the new treatment approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Advanced Foot Care, LLC
  Phoenix, Arizona, United States Recruiting
• Northwestern University Feinberg School of Medicine
  Chicago, Illinois, United States Recruiting
• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting
• University of Mississippi Medical Center
  Jackson, Mississippi, United States Recruiting
• Missouri Orthopaedic Institute
  Columbia, Missouri, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Keira Watts, Clinical Research Director
• Email: clinicaltrials@biocomposites.com
• Phone: +44 (0) 1782 338 580

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.