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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

NCT05539963 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-06-24

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Biocomposites Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2025-06-20
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05539963 on ClinicalTrials.gov