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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STIMULAN VG, Standard of Care.
- Who it may be relevant to
- Registry conditions: Pressure Ulcer, Stage IV, Osteomyelitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
Overview
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.
Detailed description
The trial is an open-label, multi-center, randomized (1:1), controlled phase 2 trial in patients diagnosed with stage IV pressure ulcers.
Interventions
- Combination product STIMULAN VG
Insertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure. - Procedure Standard of Care
Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Primary outcome measures
- Individual patient success and findings at the 8 week follow-up visit [Time frame: 8 week]
Eligibility criteria
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure.
- Operative candidate for flap surgery or primary closure.
- Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.
- Adults ≥ 18 years in age at the time of treatment.
- Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
- 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:
- Reasons contributing to pressure ulcer cannot be addressed.
- Severe immunological compromised patients as determined by the clinician.
- Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.
- Patients presenting with head pressure ulcers.
- 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.
- Current smoker.
- Diabetic patient with Hba1C level above 9.
- Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).
- Concurrent involvement in a study of another investigational product.
- Pregnant or planning to become pregnant during study period.
- Flexion contractures where patient cannot passively get full extension.
- Uncontrolled muscle spasms.
- Unable to comply with bedrest restriction or offloading requirements
- Unable to provide consent.
- Fecal or urinary incontinence with contamination of the wound.
- 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 \*
- Investigator considers the participant to be clinically malnourished.
- Any conditions with known hypercalcemia (> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Advanced Foot Care, LLC — Phoenix
- Northwestern University Feinberg School of Medicine — Chicago
- Henry Ford Hospital — Detroit
- University of Mississippi Medical Center — Jackson
- Missouri Orthopaedic Institute — Columbia
- University of Nebraska Medical Center — Omaha
- Rutgers New Jersey Medical School — Newark
- NYU Langone Hospital - Long Island Clinical Research Center — Mineola
- … and 1 more center
Identifiers
NCT: NCT06283979 · 199723