Results from BIG D-FOOT study using STIMULAN® when treating DFO to be presented at EBJIS 2025

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Biocomposites Ltd

09 Sep, 2025, 07:30 GMT

  • Randomised, double-blinded, controlled BIG D-FOOT study demonstrates that local antibiotic delivery using STIMULAN® significantly reduces post-surgical infective complications in patients with diabetic foot osteomyelitis (DFO)
  • Biocomposites symposium will explore best practice treatment strategies for complex infections and share findings from the BIG D FOOT study

KEELE, England, Sept. 9, 2025 /PRNewswire/ -- Biocomposites, an international medical devices company that engineers, manufactures and markets world-leading products for use in infection management in bone and soft tissue, today announces its participation as a Platinum Sponsor of the 43rd Annual Meeting of the European Bone & Joint Infection Society (EBJIS), taking place on 11-13 September 2025 at the Bologna Congress Centre in Bologna, Italy.

Biocomposites will be showcasing its pioneering infection management solutions, including STIMULAN®, the only absorbable calcium matrix approved for use with antibiotics in bone and soft tissue; and SYNICEM Spacers, the preformed antibiotic loaded spacers designed to maintain space and aid in the treatment of infection. 

The Biocomposites symposium, titled "From diabetic foot osteomyelitis to peri-prosthetic joint infection: what are the most appropriate treatment strategies?", will be moderated by Dr Massimiliano De Paolis and Professor Pierluigi Viale, and will feature leading clinicians discussing innovations in infection management for complex and high-risk patient groups.

The session will include Dr Matteo Monami, lead author of the BIG D-FOOT study, presenting results from the first double-blind, randomised controlled trial evaluating local antibiotic delivery using STIMULAN® in diabetic foot osteomyelitis (DFO).

Key findings from the BIG D-FOOT study include:

  • Significant superiority of antibiotic-loaded STIMULAN® over placebo in preventing infective complications including DFO recurrence
  • Study terminated early, due to compelling efficacy results
  • Patient in the placebo arm who later received STIMULAN® plus antibiotics achieved full healing within two months
  • Cost analysis showed economic sustainability comparable to traditional approaches.

These results provide strong clinical and economic validation for the use of STIMULAN® in managing complex diabetic foot infections, offering surgeons an effective, localised strategy for improving outcomes in challenging DFO cases.

Michael Harris, CEO of Biocomposites, commented: "We are delighted to support the annual meeting of the European Bone & Joint Infection Society (EBJIS) again this year, and to highlight the growing body of evidence supporting STIMULAN®'s use in managing serious infections. The BIG D-FOOT study represents an important milestone in demonstrating the clinical and economic benefits of using STIMULAN® for local antibiotic delivery when treating diabetic foot osteomyelitis."

Details of Biocomposites' symposium at the EBJIS Annual Meeting are listed below.

Symposium Details

Title: From diabetic foot osteomyelitis to peri-prosthetic joint infection: what are the most appropriate treatment strategies?

Location: Room Sala Italia, Bologna Congress Centre

Date & Time: Friday 12 September 2025, 12:50-13:50 CEST

Moderators:

  • Dr Massimiliano De Paolis, Medical Director of Complex Structure: Orthopaedics and Traumatology Unit, IRCCS Bologna University Hospital Professor
  • Professor Pierluigi Viale, Professor of Medicine – Infectious Diseases at the Department of Medical and Surgical Sciences of the Alma Mater Studiorum University of Bologna

Speakers: 

  • Dr Matteo Monami, Medical Doctor, Azienda Ospedaliero Universitaria Careggi: "Results of the first double-blind RCT in diabetic foot osteomyelitis"
  • Professor Pier Francesco Indelli, Academic Orthopaedic Surgeon, VA Palo Alto Health Care System (PAVAHCS) and Assistant Professor in Adult Reconstruction, Department of Orthopaedic Surgery and Bioengineering, Stanford University School of Medicine: "New recommendations on local antibiotic administration: what changes after the 2025 Consensus Meeting?"
  • Dr Antonia Scobie, Consultant in Infectious Diseases and Medical Microbiology, The Royal Free NHS Foundation Trust and The Royal National Orthopaedic Hospital NHS Trust: "The role of local antimicrobials and bacteriophages in DFI"

About Biocomposites

Biocomposites is an international medical device company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, South America, USA, Canada, China and India. Biocomposites is a world leader in the development of innovative calcium compounds for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry and sports injuries. Biocomposites products are now used in over 1 million procedures per annum and sold in more than 100 countries around the world. Please visit biocomposites.com to learn more.

About EBJIS

The European Bone & Joint Infection Society (EBJIS) is a dedicated community of medical professionals and scientists committed to advancing knowledge and fostering excellence in the prevention and treatment of musculoskeletal infections. Its annual meeting is a premier event bringing together experts, practitioners, and industry leaders for high-level scientific exchange and networking. For more information, visit https://ebjis.org/ebjis2025/