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 of the Forefoot. — BLADE-VG2  

Diabetic Foot Osteomyelitis Clinical Trial

Official title: 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 of the Forefoot

Status Recruiting

Clinical Trial 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) of the forefoot.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Osteomyelitis
• Osteomyelitis

• NCT number: NCT05539963
• Study type: Interventional
• Source: Biocomposites Ltd
• Contact: Keira Watts, Clinical Project Manager
• Phone: +44 (0) 1782 338 580
• Email: clinicaltrials@biocomposites.com
• Status: Recruiting
• Phase: Phase 2
• Start date: January 23, 2023
• Completion date: June 30, 2025