STIMULAN VG for Bed Sores

(BLADE OPU2 Trial)

Overseen By Keira Watts, Clinical Research Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biocomposites Ltd

Must not be taking: Recreational drugs, Narcotics, Alcohol

Disqualifiers: Substance abuse, Smoking, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with severe stage IV pressure ulcers and bone infection (osteomyelitis) confirmed by MRI or CT scan. Candidates must need surgery involving excision, bony debridement, and flap coverage, and be able to follow the study's procedures. Exclusion criteria are not specified.

Inclusion Criteria

I am mentally and physically capable of following the study's requirements.

Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures

I am eligible for surgery to repair my wound with skin flaps or direct closure.

Exclusion Criteria

I cannot follow bedrest or specific movement restrictions.

Severe immunologically compromised patients as determined by the clinician

Diabetic patient with Hba1C level above 9

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ulcer bursectomy, debridement, and receive either STIMULAN VG insertion or standard of care with peri-operative antibiotics

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on wound closure and healing

8 weeks

2 visits (in-person)

Treatment Details

Interventions

• STIMULAN VG

Trial Overview The trial compares STIMULAN VG combined with systemic antibiotics and surgical debridement against standard care which includes only systemic antibiotics and surgical debridement. The goal is to see if STIMULAN VG improves treatment outcomes for osteomyelitis in patients with stage IV pressure ulcers.

Participant Groups

Group I: Interventional STIMULAN VG Experimental Treatment 2 Interventions

Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity. Flap/primary closure. Peri-operative antibiotics.

Group II: Standard of Care (SoC) Active Control 1 Intervention

Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.

Who Is Running the Clinical Trial?

Biocomposites Ltd

Lead Sponsor

Trials

6

Recruited

270+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+