NCT06283979

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.

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Biocomposites Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pressure Ulcer, Stage IV
• Osteomyelitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-28
• Last updated: 2026-04-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study