RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)

NCT06388603 · tracked via the Priya Life Science Italy tracker

Sponsor

ASST Ovest Milanese

Phase

Not applicable

Started

2024-03-21

Last updated

2024-04-29

Condition(s) studied

Osteomyelitis - Foot

Investigational drug(s) / intervention(s)

Bioactive GlassStandard of Care

Bioactive Glass: 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 Care: 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 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

Inclusion Criteria: 1. Written informed consent obtained. 2. Male or female patients \>= of 18 years old. 3. They should have type I since at least 5 years or type II DM 4. 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. 5. 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. 6. 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. 7. Anatomical area: forefoot. Exclusion Criteria: 1. They should not have metabolic decompensation as witnessed by HbA1c \>109 mmol/mol (\> 12%). 2. They should not have major amputation on the contra-lateral limb. 3. They should not have acute or chronic Charcot's foot in the affected foot. 4. They should not have undergone surgical or endovascular revascularization in the affected foot in the month preceding the enrollment. 5. 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. 6. They should not have ESRD in dialysis. 7. They should not be bedridden or not ambulating. 8. They should not have a life expectancy shorter than one year. 9. They should not be too ill to sustain a surgical procedure under loco-regional anesthesia. 10. They should not have severe disease which might interfere with the expected course of the disease and therapy. 11. Hypersensitivity to any product ingredient(s) or history of anaphylactic reactions. 12. Participation in another interventional studies within 45 days prior to the start of the present study. 13. Predictable poor compliance or inability to communicate well with the investigator.

Primary outcome measure(s)

healing rate — 6-month
complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits.

Trial sites (7)

Facility	City	Region	Status
ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone	Monfalcone	Gorizia	Not Yet Recruiting
ASST Ovest Milanese - Ospedale di Abbiategrasso	Abbiategrasso	Milano	Recruiting
Casa di Cura Abano Terme - POLICLINICO ABANO TERME	Abano Terme	Padova	Not Yet Recruiting
USL Sud Est Toscana - Ospedale San Donato	Arezzo	Italy	Not Yet Recruiting
AUSL Romagna - Ospedale Morgagni Pierantoni	Forlì	Italy	Not Yet Recruiting
Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte	Lucca	Italy	Not Yet Recruiting
AOU Pisana - Ospedale di Cisanello	Pisa	Italy	Not Yet Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06388603 on ClinicalTrials.gov ↗ ← All trials in Italy