Trial reportDiabetes, obesity & metabolism2025
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.
Trial report in Diabetes, obesity & metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- 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, obesity & metabolism · 2025Trial
- Limb Salvage Using Local Antibiotic Beads for Calcaneal Osteomyelitis With Multidrug-resistant Infection and Chronic Limb-threatening Ischemia.Plastic and reconstructive surgery. Global open · 2026Article
- Engineering Smart Scaffolds for Osteomyelitis: Integrating Nanotechnology, Drug Delivery, and Tissue Regeneration-A Narrative Review.Journal of functional biomaterials · 2026Review
- Osteomyelitis.Nature reviews. Disease primers · 2026Review
- Managing Bone Infections Beyond Systemic Antibiotics: A Scoping Review.Pathogens (Basel, Switzerland) · 2026Review
- Sculpting the Future of Bone: The Evolution of Absorbable Materials in Orthopedics.Advanced materials (Deerfield Beach, Fla.) · 2026Review
- Synergistic integration of biomaterials in orthopedic implantation for infection preventing and tissue engineering.Regenerative biomaterials · 2026Review
- Article
- Novel Treatments for Diabetic Foot Osteomyelitis: A Narrative Review.Microorganisms · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDiabetic foot osteomyelitis (DFO) is associated with a considerably high risk of incident major amputations, disability and mortality. To assess the effects of a local antibiotic delivery system on the incidence of post-surgical infective complications in patients with DFO.
methodsThis is a double-blind, placebo-controlled, parallel series, randomized controlled trial (RCT) aimed at verifying the efficacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (either with tobramycin or vancomycin) in patients with DFO treated with surgical procedures. The trial enrolled adult patients with diabetes and Texas 3 grade ulcers complicated by osteomyelitis and accompanied by deep tissues infection. The primary end-point was the percentage of infective complications (composite end-point of dehiscence, infection, DFO recurrence and new DFO in adjacent sites) at 12 weeks.
resultsThe study was prematurely terminated after the completion of the first 20 cases, because of the significant superiority of the active treatment arm. After 12 weeks of treatment, five of 20 wounds (25%) achieved the primary composite end-point. All post-surgical infective complications occurred in the placebo group, with a significant between-group difference (unadjusted p = 0.010). No between-group differences in overall costs were observed.
conclusionsThis 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.
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