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.

Osteomyelitis Clinical Trial

— BLADE OPU2  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283979
• Other study ID #: 199723
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: Biocomposites Ltd
• Contact: Keira Watts, Clinical Project Manager
• Phone: +44 (0) 1782 338 580
• Email: clinicaltrials[@]biocomposites.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The trial is an open-label, multi-center, randomized (1:1), controlled phase 2 trial in patients diagnosed with stage IV pressure ulcers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteomyelitis
• Pressure Ulcer
• Pressure Ulcer, Stage IV
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biocomposites Ltd	MCRA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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