Osteomyelitis - FootDFORCTNCT06388603
RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)
A study testing Bioactive Glass in people with Osteomyelitis - Foot, run by ASST Ovest Milanese at 7 sites in Italy.
Trial summary
The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteomyelitis - Foot
- What is being tested?
- Bioactive Glass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 7 sitesItaly
- Study dates
- 21 Mar 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained.
- Male or female patients >= of 18 years old.
- They should have type I since at least 5 years or type II DM
- They should have a diagnosis - confirmed by imaging and culture - of OM localized in the forefoot not responding for at least 2 up to 6 weeks to systemic antibiotic therapy and/or associated with soft tissue infection, abscess, phlegmon, necrosis, and for which a surgical debridement is indicated.
- They should have palpable pulses on TP or DP at the ankle in the affected limb, and/or ABPI >0.7 and <1.2 and /or TcPO2 at dorsum of the foot ≥36 mmHg.
- They should be able to accomplish with the procedures and prescriptions indicated by the Study protocol, particularly with the offloading prescription, as well as they should be willing and able to attend and respect the program of control visits and medications.
- Anatomical area: forefoot.
Who cannot join
- They should not have metabolic decompensation as witnessed by HbA1c >109 mmol/mol (> 12%).
- They should not have major amputation on the contra-lateral limb.
- They should not have acute or chronic Charcot's foot in the affected foot.
- They should not have undergone surgical or endovascular revascularization in the affected foot in the month preceding the enrollment.
- They should not be taking corticosteroids, bisphosphonates, immunosuppressants, and more in general any drug which might interfere with bone metabolism or tissue repair, in thejudgment of investigators.
- They should not have ESRD in dialysis.
Show all 13Show fewer
- They should not be bedridden or not ambulating.
- They should not have a life expectancy shorter than one year.
- They should not be too ill to sustain a surgical procedure under loco-regional anesthesia.
- They should not have severe disease which might interfere with the expected course of the disease and therapy.
- Hypersensitivity to any product ingredient(s) or history of anaphylactic reactions.
- Participation in another interventional studies within 45 days prior to the start of the present study.
- Predictable poor compliance or inability to communicate well with the investigator.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Not yet recruiting
Casa di Cura Abano Terme - POLICLINICO ABANO TERME
Abano Terme, Padova, 35031
Dr. Christine Whisstock, Med Doctor, +39 338 8924624, cwhisstock@casacura.it
Dr. Christine Whisstock, Med Doctor
- Recruiting
ASST Ovest Milanese - Ospedale di Abbiategrasso
Abbiategrasso, Milano, 20081
Dr. Roberto De Giglio, Med Doctor, +39 331 6989775, roberto.degiglio@asst-ovestmi.it
Dr. Roberto De Giglio, Med Doctor
- Not yet recruiting
USL Sud Est Toscana - Ospedale San Donato
Arezzo, 52100
Dr. Alessia Scatena, Med Doctor, +39 328 3281501, alessia.scatena@uslsudest.toscana.it
Dr. Alessia Scatena, Med Doctor
- Not yet recruiting
AUSL Romagna - Ospedale Morgagni Pierantoni
Forlì, 47121
Dr. Silvia Acquati, Med Doctor, +39 335 1239344, silvia.acquati@auslromagna.it
Dr. Silvia Acquati, Med Doctor
- Not yet recruiting
Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte
Lucca, 55100
Dr. Ilaria Casadidio, Med. Doctor, +39 3284882078, ilaria.casadidio@uslnordovest.toscana.it
Dr. Ilaria Casadidio, Med Doctor
- Not yet recruiting
ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone
Monfalcone, Gorizia, 34074
Dr. Roberto Da Ros, Med Doctor, +39 3470606008, roberto.daros@aas2.sanita.fvg.it
Dr. Roberto Da Ros, Med Doctor
- Not yet recruiting
AOU Pisana - Ospedale di Cisanello
Pisa, 5612
Prof. Alberto Piaggesi, Med Doctor, +39 3473331949, alberto.piaggesi@med.unipi.it
Dr. Chiara Goretti, Med Doctor, +39 3294125791, chiara.goretti@gmail.com
About this study
Official title: A National, Prospective, Randomized, Multicenter, Controlled Comparison of Bioactive Glass S53P4 Versus Standard of Care Treatment of Diabetic Foot Osteomyelitis in the Forefoot
The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.
Participants will randomized into two groups:
- Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.
- Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.
Read the detailed description
Patient with a diagnosis of ostemileytis localised in the forefoot will be randomized into two groups.
- Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.
- Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.
In any case a primary intent closure is pursued, both in Group A and B, a vacuum percutaneous drainage would be placed before closing the wound and removed in 2nd post-operative day, if necessary, by the surgeon.
Systemic antibiotic therapy will be started immediately on empirical basis, as per normal practice.
After the removal of drainage, or after the first post-operative control in 2nd post-operative day, as done routinely at study sites, patients will be evaluated biweekly either if they are still admitted or if they were dismissed and will be followed up by investigators blinded toward the groups.
At each visit local conditions and eventual dressing changes will be recorded, alongside with any possible complication, like non-healing, re-infection, and any systemic and local adverse event.
Patients will be followed every second week up to 3 months or until complete healing and then at six months and 12 months from surgical interventions. At six-month and 12 -month follow-up, rate of healing and recurrences will be checked; x-rays will be performed at pre-operation visit, immediate post and at 12 months Follow Up visit. Histopathological samples collected as per normal practice during the surgery will be analyzed with standard protocol in local laboratories. Healing will be defined as complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits. For the sake of calculating healing time, healing will be attributed to the first visit. At each visits a local and systemic evaluation of the wound will be done as per normal practice. A photo of the wound will be taken at visits: Pre-operative , Immediate post-op, 6 weeks post-op, 6 months and 12 months after the surgical procedure. Laboratory exams will be performed as per hospital standard of care. At pre-operative and 6 months and 12 months visits patients compile Quality of Life and Foot Function Index Questionnaires.
- Conditions
- Osteomyelitis - Foot
- Being tested
- Bioactive Glass, Standard of Care
- Keywords
- Diabetic Foot, Osteomyelitis, Forefoot
- Medical subject headings
- Diabetic Foot, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive GlassDevice
Also called Bonalive Granules RDM: 856052; manufacturer code:13120, Bonalive Putty RDM: 855194; manufacturer code:16120
Bonalive Granules and Bonalive Putty will be used (according to their IFU and CE certification) to fill the bone void after the debridment of infected tissue as they have osteoconductive and osteostimulative properties that allow bone rigeneration. Moreover, Bonalive Granules also present some bacteria growth inhibiting properties to combact bone infection propoer of Ostemyelitis.
Standard of CareOther
The investigators are left free to proceed according to the normal standar procedure they normally use. The procedures can vary according to investigator judgment also depending on the state of Osteomylitis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care - Osteomyelitis treatment | Active comparator | Subjects randomized in this group will be treated according to standard of care for the surgical managment of Osteomyelitis in the forefoot in patient suffering from diabetic foot syndrome. All standard of care approaches will be allowed (e.g use of bone sobsitutes, cements, cements loaded with antibiotics etc) with the only exception of Bioactive Glasses. Receives: Other: Standard of Care |
| Bioactive Glass | Experimental | Subjects randomized in this group will be treated using the S53P4 Bioactive Glass of Bonalive Biomaterials Ltd; in the form of:
* Bonalive Granules 2.5 CC (0.5-0.8 MM)
* Bonalive Putty 2.5 CC (SIRINGA 0.5-0.8 MM)
The quantity that will be implanted will vary according to the bone cavity of each patient. Receives: Device: Bioactive Glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rate
complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits.
Measured: 6-month
Secondary outcomes (10)
Duration of antibiotic therapy
systemic antibiotic therapy will be prescribed after intervention and its duration can vary according to infection state.
Measured: through study completion, an average of 1 year
Rate of recurrences
After intervention bone infections proper of osteomyelitis can recur
Measured: 6-months and 12-month
Number of re-interventions because of the same lesion
If an infection recur might be necessery to procede with a re-intervention.
Measured: through study completion, an average of 1 year
Timing of re-interventions because of the same lesion
If an infection recur might be necessery to procede with a re-intervention.
Measured: through study completion, an average of 1 year
Proportion of patients undergoing amputations
In same severe cases minor or major amputations can be neccessary
Measured: through study completion, an average of 1 year
Patients' Quality of Life
The quality of life of patient will be evaluated using EQ-5D-5L from 0 (worse) to 100 (better)
Measured: 6-months and 12-month
Patients' Quality of Life
The quality of life of patient will be evaluated with Foot Function Index from 0 (better) to 170 (worse)
Measured: 6-months and 12-month
Time back to walk
It will be registered when patients can go back to walk aftern the intervention
Measured: through study completion, an average of 1 year
Characteristics of surgery
data about characteristics (type) of surgeries will be collected
Measured: intra-operative
Length of surgery
data about the lenght (timing) of surgeries will be collected
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start21 Mar 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Osteomyelitis - FootStudies 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
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Ovest Milanese
- Sponsor type
- University, hospital or other
- Collaborators
- Hippocrates Research, Bonalive Biomaterials Ltd
- Responsible party
- Sponsor
- Investigators
- Dr. Roberto De Giglio, Med Doctor, Principal investigator, ASST Ovest Milanese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388603
- Sponsor's protocol ID
- DFORCT012023
- Acronym
- DFORCT
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Giglio R, Di Vieste G, Mondello T, Balduzzi G, Masserini B, Formenti I, Lodigiani S, Pallavicini D, Pintaudi B, Mazzone A. Efficacy and Safety of Bioactive Glass S53P4 as a Treatment for Diabetic Foot Osteomyelitis. J Foot Ankle Surg. 2021 Mar-Apr;60(2):292-296. doi: 10.1053/j.jfas.2020.06.029. Epub 2020 Sep 6.
PubMed 33358382Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. doi: 10.1007/s00125-006-0491-1. Epub 2006 Nov 9.
PubMed 17093942Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Tennvall GR, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, Van Baal J, Van Merode F, Schaper N. Delivery of care to diabetic patients with foot ulcers in daily practice: results of the Eurodiale Study, a prospective cohort study. Diabet Med. 2008 Jun;25(6):700-7. doi: 10.1111/j.1464-5491.2008.02445.x.
PubMed 18544108Lipsky BA, Aragon-Sanchez J, Diggle M, Embil J, Kono S, Lavery L, Senneville E, Urbancic-Rovan V, Van Asten S; International Working Group on the Diabetic Foot; Peters EJ. IWGDF guidance on the diagnosis and management of foot infections in persons with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:45-74. doi: 10.1002/dmrr.2699. No abstract available.
PubMed 26386266Lalidou F, Kolios G, Drosos GI. Bone infections and bone graft substitutes for local antibiotic therapy. Surg Technol Int. 2014 Mar;24:353-62.
PubMed 24504740Hanssen AD. Local antibiotic delivery vehicles in the treatment of musculoskeletal infection. Clin Orthop Relat Res. 2005 Aug;(437):91-6. doi: 10.1097/01.blo.0000175713.30506.77.
PubMed 16056032Vatan A, Saltoglu N, Yemisen M, Balkan II, Surme S, Demiray T, Mete B, Tabak F; Study Group, Cerrahpasa Diabetic Foot. Association between biofilm and multi/extensive drug resistance in diabetic foot infection. Int J Clin Pract. 2018 Mar;72(3):e13060. doi: 10.1111/ijcp.13060. Epub 2018 Jan 30.
PubMed 29381248Lindfors NC, Hyvonen P, Nyyssonen M, Kirjavainen M, Kankare J, Gullichsen E, Salo J. Bioactive glass S53P4 as bone graft substitute in treatment of osteomyelitis. Bone. 2010 Aug;47(2):212-8. doi: 10.1016/j.bone.2010.05.030.
PubMed 20624692Peltola M, Aitasalo K, Suonpaa J, Varpula M, Yli-Urpo A. Bioactive glass S53P4 in frontal sinus obliteration: a long-term clinical experience. Head Neck. 2006 Sep;28(9):834-41. doi: 10.1002/hed.20436.
PubMed 16823870McAndrew J, Efrimescu C, Sheehan E, Niall D. Through the looking glass; bioactive glass S53P4 (BonAlive(R)) in the treatment of chronic osteomyelitis. Ir J Med Sci. 2013 Sep;182(3):509-11. doi: 10.1007/s11845-012-0895-5. Epub 2013 Jan 5.
PubMed 23292733Piaggesi A, Goretti C, Iacopi E, Clerici G, Romagnoli F, Toscanella F, Vermigli C. Comparison of Removable and Irremovable Walking Boot to Total Contact Casting in Offloading the Neuropathic Diabetic Foot Ulceration. Foot Ankle Int. 2016 Aug;37(8):855-61. doi: 10.1177/1071100716643429. Epub 2016 Apr 15.
PubMed 27083507Kastrin M, Urbancic Rovan V, Frangez I. Possible Advantages of S53P4 Bioactive Glass in the Treatment of Septic Osteoarthritis of the First Metatarsophalangeal Joint in the Diabetic Foot. J Clin Med. 2021 Mar 15;10(6):1208. doi: 10.3390/jcm10061208.
PubMed 33803930Iacopi E, Pieruzzi L, Goretti C, Piaggesi A. Pilot Experience on the Use of S53P4 Bioactive Glass in the Surgical Management of Diabetic Foot Osteomyelitis. Int J Low Extrem Wounds. 2022 Mar;21(1):57-64. doi: 10.1177/1534734620926003. Epub 2020 Jun 8.
PubMed 32506987Munukka E, Lepparanta O, Korkeamaki M, Vaahtio M, Peltola T, Zhang D, Hupa L, Ylanen H, Salonen JI, Viljanen MK, Eerola E. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria. J Mater Sci Mater Med. 2008 Jan;19(1):27-32. doi: 10.1007/s10856-007-3143-1. Epub 2007 Jun 14.
PubMed 17569007
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective, Randomized, Multicenter, Controlled Comparison of Bioactive Glass S53P4 Versus Standard of Care Treatment of Diabetic Foot Osteomyelitis in the Forefoot
- ClinicalTrials.gov ID
- NCT06388603
- Acronym / sponsor ID
- DFORCT / DFORCT012023
- Conditions
- Osteomyelitis - Foot
- Keywords
- Diabetic Foot, Osteomyelitis, Forefoot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- ASST Ovest MilaneseUniversity, hospital or other
- Collaborators
- Hippocrates Research, Bonalive Biomaterials Ltd
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Apr 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.
The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.
Participants will randomized into two groups:
- Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.
- Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.
Detailed description
Patient with a diagnosis of ostemileytis localised in the forefoot will be randomized into two groups.
- Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.
- Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.
In any case a primary intent closure is pursued, both in Group A and B, a vacuum percutaneous drainage would be placed before closing the wound and removed in 2nd post-operative day, if necessary, by the surgeon.
Systemic antibiotic therapy will be started immediately on empirical basis, as per normal practice.
After the removal of drainage, or after the first post-operative control in 2nd post-operative day, as done routinely at study sites, patients will be evaluated biweekly either if they are still admitted or if they were dismissed and will be followed up by investigators blinded toward the groups.
At each visit local conditions and eventual dressing changes will be recorded, alongside with any possible complication, like non-healing, re-infection, and any systemic and local adverse event.
Patients will be followed every second week up to 3 months or until complete healing and then at six months and 12 months from surgical interventions. At six-month and 12 -month follow-up, rate of healing and recurrences will be checked; x-rays will be performed at pre-operation visit, immediate post and at 12 months Follow Up visit. Histopathological samples collected as per normal practice during the surgery will be analyzed with standard protocol in local laboratories. Healing will be defined as complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits. For the sake of calculating healing time, healing will be attributed to the first visit. At each visits a local and systemic evaluation of the wound will be done as per normal practice. A photo of the wound will be taken at visits: Pre-operative , Immediate post-op, 6 weeks post-op, 6 months and 12 months after the surgical procedure. Laboratory exams will be performed as per hospital standard of care. At pre-operative and 6 months and 12 months visits patients compile Quality of Life and Foot Function Index Questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care - Osteomyelitis treatment | Active comparator | Other: Standard of CareSubjects randomized in this group will be treated according to standard of care for the surgical managment of Osteomyelitis in the forefoot in patient suffering from diabetic foot syndrome. All standard of care approaches will be allowed (e.g use of bone sobsitutes, cements, cements loaded with antibiotics etc) with the only exception of Bioactive Glasses. |
| Bioactive Glass | Experimental | Device: Bioactive GlassSubjects randomized in this group will be treated using the S53P4 Bioactive Glass of Bonalive Biomaterials Ltd; in the form of: * Bonalive Granules 2.5 CC (0.5-0.8 MM) * Bonalive Putty 2.5 CC (SIRINGA 0.5-0.8 MM) The quantity that will be implanted will vary according to the bone cavity of each patient. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained.
- Male or female patients >= of 18 years old.
- They should have type I since at least 5 years or type II DM
- They should have a diagnosis - confirmed by imaging and culture - of OM localized in the forefoot not responding for at least 2 up to 6 weeks to systemic antibiotic therapy and/or associated with soft tissue infection, abscess, phlegmon, necrosis, and for which a surgical debridement is indicated.
- They should have palpable pulses on TP or DP at the ankle in the affected limb, and/or ABPI >0.7 and <1.2 and /or TcPO2 at dorsum of the foot ≥36 mmHg.
Key exclusion criteria (13 listed)
- They should not have metabolic decompensation as witnessed by HbA1c >109 mmol/mol (> 12%).
- They should not have major amputation on the contra-lateral limb.
- They should not have acute or chronic Charcot's foot in the affected foot.
- They should not have undergone surgical or endovascular revascularization in the affected foot in the month preceding the enrollment.
- They should not be taking corticosteroids, bisphosphonates, immunosuppressants, and more in general any drug which might interfere with bone metabolism or tissue repair, in thejudgment of investigators.
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 |
|---|---|---|
| Bioactive GlassAlso: Bonalive Granules RDM: 856052; manufacturer code:13120, Bonalive Putty RDM: 855194; manufacturer code:16120Bonalive Granules and Bonalive Putty will be used (according to their IFU and CE certification) to fill the bone void after the debridment of infected tissue as they have osteoconductive and osteostimulative properties that allow bone rigeneration. Moreover, Bonalive Granules also present some bacteria growth inhibiting properties to combact bone infection propoer of Ostemyelitis. | Device | Bioactive Glass |
| Standard of CareThe investigators are left free to proceed according to the normal standar procedure they normally use. The procedures can vary according to investigator judgment also depending on the state of Osteomylitis. | Other | Standard of Care - Osteomyelitis treatment |
Primary outcome
healing rate
Time frame: 6-month
complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits.
10 secondary outcomes
Duration of antibiotic therapy
Time frame: through study completion, an average of 1 year
Rate of recurrences
Time frame: 6-months and 12-month
Number of re-interventions because of the same lesion
Time frame: through study completion, an average of 1 year
Timing of re-interventions because of the same lesion
Time frame: through study completion, an average of 1 year
Proportion of patients undergoing amputations
Time frame: through study completion, an average of 1 year
Patients' Quality of Life
Time frame: 6-months and 12-month
Patients' Quality of Life
Time frame: 6-months and 12-month
Time back to walk
Time frame: through study completion, an average of 1 year
Characteristics of surgery
Time frame: intra-operative
Length of surgery
Time frame: intra-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 33358382De Giglio R, Di Vieste G, Mondello T, Balduzzi G, Masserini B, Formenti I, Lodigiani S, Pallavicini D, Pintaudi B, Mazzone A. Efficacy and Safety of Bioactive Glass S53P4 as a Treatment for Diabetic Foot Osteomyelitis. J Foot Ankle Surg. 2021 Mar-Apr;60(2):292-296. doi: 10.1053/j.jfas.2020.06.029. Epub 2020 Sep 6.
- Background: PubMed 17093942Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. doi: 10.1007/s00125-006-0491-1. Epub 2006 Nov 9.
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- Individual participant dataSharing planned: No
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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.
Dr. Roberto De Giglio, Med Doctor principal investigator
ASST Ovest Milanese
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Glass in people with Osteomyelitis - Foot, run by ASST Ovest Milanese at 7 sites in Italy.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Roberto De Giglio, Med Doctor (+39 331 6989775, roberto.degiglio@asst-ovestmi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing rate (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388603, which also lists 14 linked publications.
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 29 Apr 2024.