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)

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: Not yet recruiting
• Conditions: Osteomyelitis; Pressure Ulcer, Stage IV
• Intervention / Treatment: Combination product: STIMULAN VG; Procedure: Standard of Care

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

Contacts and Locations

• Study Contact: Name: Keira Watts, Clinical Project Manager; Phone Number: +44 (0) 1782 338 580; Email: clinicaltrials@biocomposites.com
• Study Contact Backup: Name: Nicole Villagomez; Phone Number: (202) 552-5800; Email: nvillagomez@mcra.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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 ulcers requiring treatment of excision, bony debridement and flap coverage.
2. Operative candidate for flap surgery.
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.

Exclusion Criteria:

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. Patients receiving primary closure
3. Severe immunological compromised patients as determined by the clinician.
4. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.
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.
14. Unable to provide consent.
15. Fecal or urinary incontinence with contamination of the wound.
16. Unable to achieve wheelchair and cushion offloading of pressure wound prior to surgery - as demonstrated by pressure mapping.
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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 closure. Peri-operative antibiotics.	Combination product: STIMULAN VG; Insertion of STIMULAN VG into the ulcer cavity prior to flap closure.; Procedure: Standard of Care; Standard of Care. Ulcer bursectomy, debridement and flap closure. Peri-operative antibiotics.
Active Comparator: Standard of Care (SoC); Ulcer bursectomy, debridement and flap closure. Peri-operative antibiotics.	Procedure: Standard of Care; Standard of Care. Ulcer bursectomy, debridement and flap 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	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

• Sponsor: Biocomposites Ltd
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

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 (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: systemic antibiotics; between-group effect size; surgical debridement; ulcer bursectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Skin Ulcer; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Ulcer; Pressure Ulcer; Osteomyelitis
• 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