Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study
BIG D-FOOT
Efficacy and Safety of aBIo- Absorbable Antibiotic Delivery in Calcium Sulphate Granules (Stimulan®) for the Treatment of Osteomyelitis in Patients With Diabetic FOOT: a Randomised, Double Blind, Controlled Clinical Study. The BIG D-FOOT Study
1 other identifier
interventional
50
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
February 16, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedFebruary 16, 2024
February 1, 2024
1 year
January 30, 2024
February 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The composite primary endpoint of this study will be the incidence osteomyelitis recurrence or new osteomyelitis in adjacent sites or tissue infection at the site of osteomyelitis.
Post-surgical infective complications
3 months
Secondary Outcomes (12)
Proportion of healed patients
3 months
Proportion of osteomyelitis recurrence
3 months
Proportion of post-surgical tissue infection
3 months
Proportion of wound recurrence
3 months
Proportion of patients undergoing major amputation
3 months
- +7 more secondary outcomes
Study Arms (2)
Calcium-sulphate granules with tobramicina+vancomicina
EXPERIMENTALCalcium-sulphate granules without antibioitcs
SHAM COMPARATORInterventions
Local calcium-sulphate antibiotics deliver for the treatment of diabetic foot osteomyelitis
Eligibility Criteria
You may qualify if:
- Type 1 or 2 diabetes
- Forefoot osteomyelitis
- Deep tissue infection
You may not qualify if:
- Pregnancy
- Severe cognitive impairment
- Creatinine clearance\< 30 ml/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Granules of calcium sulphate with and without antibiotics are identical and undistinguishable.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 16, 2024
Study Start
March 1, 2024
Primary Completion
March 1, 2025
Study Completion
May 31, 2025
Last Updated
February 16, 2024
Record last verified: 2024-02