NCT05539963

A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis

A Multi-center, Randomized, Controlled Feasibility Trial of STIMULAN VG and Debridement With an Abbreviated Course of Systemic Antibiotics to Debridement and a Full Course of Systemic Antibiotics for the Treatment of Diabetic Foot Osteomyelitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Biocomposites Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the safety and between-group effect size of STIMULAN VG compared to SoC treatment in patients with diabetic foot osteomyelitis (DFO).

Detailed description

This trial is an open-label, multi-center, randomized, controlled feasibility trial. All participants will undergo surgical debridement and receive either STIMULAN VG and an abbreviated course of systemic antibiotic therapy (3 days ±2 days) or a full course (4-6 weeks) of systemic antibiotic therapy. The total duration of study is Approximately 55 weeks.

Conditions

• Diabetic Foot Osteomyelitis

Interventions

Type	Name	Description
DRUG	STIMULAN VG	Participants will receive STIMULAN VG via implantation during debridement surgery on Day 1.
DRUG	Systemic Antibiotics	Participants will receive Antibiotics per site-specific requirements.

Timeline

• Start date: 2023-01-23
• Primary completion: 2025-06-20
• Completion: 2025-12-30
• First posted: 2022-09-14
• Last updated: 2025-06-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study