Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study

Surgical Procedure, Unspecified Clinical Trial

— BIG D-FOOT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262854
• Other study ID #: AOU Careggi Firenze
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Matteo Monami, PhD
• Phone: 00393384027484
• Email: matteo.monami[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Osteomyelitis is a severe complication of diabetic foot ulcers, that can occur in nearly 20-60% of patients. Current treatments for diabetic foot osteomyelitis (DFO) include surgical procedures aimed at removing necrotic soft tissue, gengrene and infected bones and systemic antibiotic therapy for at least 4-6 weeks; however in some cases, prolonged antibiotic therapy is not unusual. Antibiotic therapy can be problematic for several reasons, such as the achievement of appropriate and stable therapeutic concentration at bone level, particularly due to the common presence of concomitant peripheral artery disease, and kidney impairment. In recent years, another important barrier to the treatment of DFO was the increasing incidence of resistant pathogens. On the other hand, surgical options are affected by several side effects, such as alterations of foot biomechanics possibly leading to new ulcers (the so called transfer ulcer), post-surgical infections, ecc. All these factors make the DFO treatment challenging, with a high risk of all-cause mortality and rate of patients requiring major amputations Local bio-absorbable antibiotic delivery can be a valid therapeutic option for DFO treatment. During the last 2 decades, biodegradable carriers have been developed: proteins (collagen, gelatin, thrombin etc.), synthetic polymers, grafts, and substitutes (calcium sulfate or phosphate). Local antibiotic delivery system has been widely explored to increase the duration of local antibiotic delivery and bone penetration, achieving very high local therapeutical doses (about several times higher than that obtained with systemic antibiotic therapy) with reduced systemic toxicity. Another important advantage of this device is the possibility of using very effective, but highly toxic, antibiotic such as aminoglycosides, often not taken into account for systemic therapies. Finally, this device can be used as a bone substitute filling the dead space caused by bone resection, thus reducing the incidence of reinfection. Complications of calcium sulfate are negligible and include postoperative drainage and transient hypercalcemia. There several observational studies and very few randomized trials performed on DFO exploring the efficacy of local bio-absorbable antibiotic delivery and none on Stimulan. The present 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 (either with tobramicina or vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with DFO treated with surgical procedures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 or 2 diabetes
• Forefoot osteomyelitis
• Deep tissue infection

Exclusion Criteria:

• Pregnancy
• Severe cognitive impairment
• Creatinine clearance< 30 ml/min

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus
• Diabetic Foot
• Foot Ulcer
• Osteomyelitis
• Surgical Procedure, Unspecified

Intervention

Device:
• Calcium-sulphate granules with tobramicina+vancomicina
Local calcium-sulphate antibiotics deliver for the treatment of diabetic foot osteomyelitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of healed patients	Complete rehepitelization of the ulcer	3 months
Secondary	Proportion of osteomyelitis recurrence	Recurrence of osteomyelitis in the same foot site	3 months
Secondary	Proportion of post-surgical tissue infection	Tissue infection at the surgical wound level	3 months
Secondary	Proportion of wound recurrence	New ulcer at the same site	3 months
Secondary	Proportion of patients undergoing major amputation	Above ankle amputation	3 months
Secondary	Proportion of patients undergoing new surgical intervention	New surgical intervention for osteomyelitis	3 months
Secondary	Ulcer time-to-healing	From baseline to healing (days)	3 months
Secondary	Osteomyelitis time-to-recurrence	From baseline to osteomyelitis recurrence (days)	3 months
Secondary	Any serious adverse events	Life-threatening adverse events	3 months
Secondary	Any non serious adverse events	Mild-moderate adverse events	3 months
Secondary	Proportion of post-surgical dehiscence	Post-surgical infection	7 days
Secondary	Direct medical costs	Costs for foot-related problems (hospital admission, amputation, revascularization, antibiotic therapy, medical device, etc.)	3 months