Diabete MellitusBIG D-FOOTNCT06262854
Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study
A study testing Calcium-sulphate granules with tobramicina+vancomicina in people with Diabete Mellitus and Foot Ulcer, run by Azienda Ospedaliero-Universitaria Careggi.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Foot Ulcer, Osteomyelitis - Foot
- What is being tested?
- Calcium-sulphate granules with tobramicina+vancomicina
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or 2 diabetes
- Forefoot osteomyelitis
- Deep tissue infection
Who cannot join
- Pregnancy
- Severe cognitive impairment
- Creatinine clearance< 30 ml/min
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed 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.
- Being tested
- Calcium-sulphate granules with tobramicina+vancomicina
- Keywords
- diabetes;, foot osteomyelitis;, ulcer;, calcium sulphate local antibiotic delivery;, Stimulan
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium-sulphate granules with tobramicina+vancomicinaDevice
Local calcium-sulphate antibiotics deliver for the treatment of diabetic foot osteomyelitis
| Study group | Role | What they receive |
|---|---|---|
| Calcium-sulphate granules with tobramicina+vancomicina | Experimental | Not described Receives: Device: Calcium-sulphate granules with tobramicina+vancomicina |
| Calcium-sulphate granules without antibioitcs | Sham comparator | Not described Receives: Device: Calcium-sulphate granules with tobramicina+vancomicina |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (12)
Proportion of healed patients
Complete rehepitelization of the ulcer
Measured: 3 months
Proportion of osteomyelitis recurrence
Recurrence of osteomyelitis in the same foot site
Measured: 3 months
Proportion of post-surgical tissue infection
Tissue infection at the surgical wound level
Measured: 3 months
Proportion of wound recurrence
New ulcer at the same site
Measured: 3 months
Proportion of patients undergoing major amputation
Above ankle amputation
Measured: 3 months
Proportion of patients undergoing new surgical intervention
New surgical intervention for osteomyelitis
Measured: 3 months
Ulcer time-to-healing
From baseline to healing (days)
Measured: 3 months
Osteomyelitis time-to-recurrence
From baseline to osteomyelitis recurrence (days)
Measured: 3 months
Any serious adverse events
Life-threatening adverse events
Measured: 3 months
Any non serious adverse events
Mild-moderate adverse events
Measured: 3 months
Proportion of post-surgical dehiscence
Post-surgical infection
Measured: 7 days
Direct medical costs
Costs for foot-related problems (hospital admission, amputation, revascularization, antibiotic therapy, medical device, etc.)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Monami, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262854
- Sponsor's protocol ID
- AOU Careggi Firenze
- Acronym
- BIG D-FOOT
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06262854
- Acronym / sponsor ID
- BIG D-FOOT / AOU Careggi Firenze
- Keywords
- diabetes;, foot osteomyelitis;, ulcer;, calcium sulphate local antibiotic delivery;, Stimulan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium-sulphate granules with tobramicina+vancomicina | Experimental | Device: Calcium-sulphate granules with tobramicina+vancomicina |
| Calcium-sulphate granules without antibioitcs | Sham comparator | Device: Calcium-sulphate granules with tobramicina+vancomicina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 or 2 diabetes
- Forefoot osteomyelitis
- Deep tissue infection
Key exclusion criteria (3 listed)
- Pregnancy
- Severe cognitive impairment
- Creatinine clearance< 30 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium-sulphate granules with tobramicina+vancomicinaLocal calcium-sulphate antibiotics deliver for the treatment of diabetic foot osteomyelitis | Device | Calcium-sulphate granules with tobramicina+vancomicina, Calcium-sulphate granules without antibioitcs |
Primary outcome
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.
Time frame: 3 months
Post-surgical infective complications
12 secondary outcomes
Proportion of healed patients
Time frame: 3 months
Proportion of osteomyelitis recurrence
Time frame: 3 months
Proportion of post-surgical tissue infection
Time frame: 3 months
Proportion of wound recurrence
Time frame: 3 months
Proportion of patients undergoing major amputation
Time frame: 3 months
Proportion of patients undergoing new surgical intervention
Time frame: 3 months
Ulcer time-to-healing
Time frame: 3 months
Osteomyelitis time-to-recurrence
Time frame: 3 months
Any serious adverse events
Time frame: 3 months
Any non serious adverse events
Time frame: 3 months
Proportion of post-surgical dehiscence
Time frame: 7 days
Direct medical costs
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium-sulphate granules with tobramicina+vancomicina in people with Diabete Mellitus and Foot Ulcer, run by Azienda Ospedaliero-Universitaria Careggi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Monami, PhD (00393384027484, matteo.monami@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.