MedTrace Logo

Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study

NCT06262854 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-16

No results posted yet for this study

Summary

This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.

Conditions

  • Diabete Mellitus
  • Foot Ulcer
  • Osteomyelitis - Foot
  • Surgical Procedure, Unspecified

Interventions

DEVICE

Calcium-sulphate granules with tobramicina+vancomicina

Local calcium-sulphate antibiotics deliver for the treatment of diabetic foot osteomyelitis

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-01
Completion
2025-05-31
FDA Device
Yes

More Related Trials

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 NCT06262854 on ClinicalTrials.gov