Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06262854 |
| Other study ID # |
AOU Careggi Firenze |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
