NCT05539963View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

January 23, 2023

Primary Completion Date

June 20, 2025

Study Completion Date

December 30, 2025

Conditions
Diabetic Foot Osteomyelitis
Interventions
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.

Trial Locations (10)

10019

Mount Sinai West, New York

27599

UNC School Medicine, Chapel Hill

28412

Seaside Clinical Research Institute, Wilmington

72405

NEA Baptist Clinic, Jonesboro

85024

Axsendo Clinical Research, Phoenix

85202

Titan Clinical Research, Mesa

85253

Perseverance Research Center, LLC, Scottsdale

85260

Advanced Footcare LLC, Scottsdale

89014

Viable Clinical Research, Henderson

07092

Equitable Health Partners - NJ, Mountainside

Sponsors

Lead Sponsor

Biocomposites Ltd
All Listed Sponsors
collaborator

MCRA

INDUSTRY

lead

Biocomposites Ltd

INDUSTRY

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 | Biotech Hunter | Biotech Hunter