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.
Recruiting
Phase 2Interventional Study
Pressure Ulcer, Stage IVOsteomyelitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Biocomposites Ltd · Industry
Who this trial is looking for
This trial is looking for adults with severe pressure ulcers that need surgical treatment. Participants will receive either a new treatment with STIMULAN VG and antibiotics or standard care with antibiotics alone.
Are You a Good Fit for This Trial?
You may be able to join if
I have a Stage IV pressure ulcer that needs surgery.
I am an adult aged 18 or older.
I can follow the treatment plan and attend scheduled visits.
I can provide my consent or have someone authorized to do so.
You may not be able to join if
I have conditions that cannot be treated to improve my pressure ulcer.
I have a severe immune system problem.
I have widespread pelvic osteomyelitis.
I currently smoke.
I have active substance abuse issues.
I have diabetes with an Hba1C level above 9.
I cannot stay in bed or follow offloading rules.
I have fecal or urinary incontinence that contaminates my wound.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility Criteria
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. Pr…
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
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