Efficacy and safety of a bio ‐absorbable antibiotic delivery in calcium sulphate granules for the treatment of osteomyelitis in patients with diabetic foot: A randomized, double blinded, controlled clinical study The BIG D‐ FOOT study
- prematurely terminated
- Prematurely terminated after the first 20 cases because of significant superiority of the active treatment arm
Authors' conclusion
This is the first RCT in patients with DFO showing that the use of antibiotic-impregnated calcium-sulphate granules is economically sustainable and has the potential of improving the prognosis of DFO.
Study context
- Population
- Adults with diabetes and Texas 3 grade ulcers complicated by osteomyelitis with deep tissue infection, treated with surgical proceduresterminated early
- Participants
- 20 adults
- Comparison
- Local calcium-sulphate bio-absorbable antibiotic delivery (tobramycin or vancomycin) vs placebo after surgery for diabetic foot osteomyelitis (DFO)
- Primary endpoint
- Percentage of infective complications:
- Dehiscence
- Infection
- DFO recurrence
- New DFO in adjacent sites
- Follow-up
- 12 weeks
Methodological detailsdouble-blind, placebo-controlled, parallel series
- Double-blind
- Placebo-controlled
- Parallel series
Primary result
As reported in the abstract
Post-surgical infective complications (composite)
Wounds achieving the primary composite end-point (all wounds)
5 of 20
25%
Further findings
- No between-group differences in overall costs
Original publication
Efficacy and safety of a bio ‐absorbable antibiotic delivery in calcium sulphate granules for the treatment of osteomyelitis in patients with diabetic foot: A randomized, double blinded, controlled clinical study The BIG D‐ FOOT study. Diabetes Obes Metab. Published 19 February 2025. doi:10.
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