BIG D-FOOT trial results on STIMULAN to be presented at EBJIS 2025
Biocomposites will present new clinical data from the BIG D-FOOT study at the European Bone & Joint Infection Society (EBJIS) annual meeting in Bologna this week, showing that local antibiotic delivery using STIMULAN can significantly reduce post-surgical infective complications in patients with diabetic foot osteomyelitis.
The randomised, double-blind, controlled trial is the first of its kind to assess local antibiotic delivery with STIMULAN in this patient group. The findings demonstrate superiority of antibiotic-loaded STIMULAN over placebo in preventing complications, including recurrence of diabetic foot osteomyelitis. According to the investigators, the trial was terminated early after efficacy results were deemed compelling.
Other highlights included a case where a patient initially assigned to the placebo arm later received STIMULAN alongside antibiotics and achieved full healing within two months. Cost analysis also suggested that the approach was economically sustainable compared with standard treatment.
The data will be presented by Dr Matteo Monami, the study’s lead author, during Biocomposites’ symposium on infection management at EBJIS 2025. The session, moderated by Dr Massimiliano De Paolis and Professor Pierluigi Viale, will explore strategies for complex infections ranging from diabetic foot osteomyelitis to peri-prosthetic joint infection.
Biocomposites said the results provide both clinical and economic validation for using local antibiotic delivery in managing complex diabetic foot infections, which remain a major cause of morbidity in patients with diabetes. STIMULAN is described as the only absorbable calcium matrix approved for use with antibiotics in bone and soft tissue.
Michael Harris, chief executive of Biocomposites, said: “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.”
Alongside the clinical data, Biocomposites will also showcase its broader infection management portfolio, including Synicem Spacers, preformed antibiotic-loaded devices designed to maintain space and assist in the treatment of joint infection. The company said its participation as a platinum sponsor of EBJIS reflects a long-standing commitment to supporting clinical research and education in bone and soft tissue infection management.
The EBJIS annual meeting, now in its 43rd year, brings together specialists from across Europe to discuss advances in orthopaedic infection research and practice. This year’s meeting takes place from 11 to 13 September at the Bologna Congress Centre in Italy.




