Chicago, ILNCT06283979Now EnrollingIRB Ready

Pressure Ulcer, Stage IV Clinical Trial in Chicago, IL

Access cutting-edge pressure ulcer, stage iv treatment through this clinical trial at a research site in Chicago. Study-provided care at no cost to qualified participants.

Sponsored by Biocomposites Ltd

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Expert Care in Chicago

Access pressure ulcer, stage iv specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pressure ulcer, stage iv treatment provided free

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Check if you qualify for this pressure ulcer, stage iv clinical trial in Chicago, IL

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Why Participate?

  • No-Cost Study Care

  • Local to Chicago

    Convenient for IL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Chicago site if eligible
  4. 4Begin participation

About This Pressure Ulcer, Stage IV Study in Chicago

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.

Sponsor: Biocomposites Ltd

Who Can Participate

Inclusion 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT06283979) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pressure Ulcer, Stage IV Treatment Options in Chicago, IL

If you're searching for pressure ulcer, stage iv treatment options in Chicago, IL, this clinical trial (NCT06283979) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pressure ulcer, stage iv specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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Secure · Expert Care · Chicago, IL