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. (BLADE OPU2)

May 1, 2026 updated by: Biocomposites Ltd

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Advanced Foot Care, LLC
        • Principal Investigator:
          • Jaminelli Banks, DPM
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Principal Investigator:
          • Robert Galiano, MD
        • Contact:
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ian Hoppe, MD
    • Missouri
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Jersey
      • Newark, New Jersey, United States, 07103
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital - Long Island Clinical Research Center
        • Principal Investigator:
          • Scott Gorenstein, MD
        • Contact:
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Recruiting
        • University of Pittsburgh, McGowan Institute for Regenerative Medicine
        • Contact:
          • Urmila Gnyawali
          • Phone Number: 412-624-5500
          • Email: usg2@pitt.edu
        • Contact:
        • Principal Investigator:
          • Sashwati Roy, PhD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional STIMULAN VG

Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity.

Flap/primary closure. Peri-operative antibiotics.
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.
Active Comparator: Standard of Care (SoC)
Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Procedure: Standard of Care
Standard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual patient success and findings at the 8 week follow-up visit
Time Frame: 8 week
An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocomposites Ltd

Collaborators

MCRA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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