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Compares treatment options for Pressure Ulcer, Stage IV
Official title 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.
ClinicalTrials.gov ID: NCT06283979
What this study is testing
What is STIMULAN VG?
STIMULAN VG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pressure ulcer, stage iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, people 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...
- Adults ≥ 18 years in age at the time of treatment.
See the full eligibility criteria
- In order to be eligible to participate in this study, people 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. people who meet any of the following criteria will be excluded...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Jackson, Mississippi, United States
- Columbia, Missouri, United States
- Omaha, Nebraska, United States
- Newark, New Jersey, United States
- Mineola, New York, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Chicago, Illinois, United States; Detroit, Michigan, United States; Jackson, Mississippi, United States; Columbia, Missouri, United States; Omaha, Nebraska, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.