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

April 24, 2024 updated by: ASST Ovest Milanese

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Arezzo, Italy, 52100
        • Not yet recruiting
        • USL Sud Est Toscana - Ospedale San Donato
        • Contact:
        • Principal Investigator:
          • Dr. Alessia Scatena, Med Doctor
        • Sub-Investigator:
          • Dr. Matteo Apicella, Med Doctor
      • Forlì, Italy, 47121
        • Not yet recruiting
        • AUSL Romagna - Ospedale Morgagni Pierantoni
        • Contact:
        • Principal Investigator:
          • Dr. Silvia Acquati, Med Doctor
      • Lucca, Italy, 55100
        • Not yet recruiting
        • Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte
        • Contact:
        • Principal Investigator:
          • Dr. Ilaria Casadidio, Med Doctor
      • Pisa, Italy, 5612
        • Not yet recruiting
        • AOU Pisana - Ospedale di Cisanello
        • Contact:
        • Contact:
        • Principal Investigator:
          • Prof. Alberto Piaggesi, Med Doctor
        • Sub-Investigator:
          • Dr. Chiara Goretti, Med Doctor
    • Gorizia
      • Monfalcone, Gorizia, Italy, 34074
        • Not yet recruiting
        • ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone
        • Contact:
        • Principal Investigator:
          • Dr. Roberto Da Ros, Med Doctor
    • Milano
      • Abbiategrasso, Milano, Italy, 20081
        • Recruiting
        • ASST Ovest Milanese - Ospedale di Abbiategrasso
        • Contact:
        • Principal Investigator:
          • Dr. Roberto De Giglio, Med Doctor
        • Sub-Investigator:
          • Dr. Ilaria Formenti, Med Doctor
        • Sub-Investigator:
          • Dr. Vincenzo Curci, Med Doctor
    • Padova
      • Abano Terme, Padova, Italy, 35031
        • Not yet recruiting
        • Casa di Cura Abano Terme - POLICLINICO ABANO TERME
        • Contact:
        • Principal Investigator:
          • Dr. Christine Whisstock, Med Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care - Osteomyelitis treatment
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.
Other: 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.
Experimental: Bioactive Glass

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.
Device: 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.
Other Names:
  • Bonalive Granules RDM: 856052; manufacturer code:13120
  • Bonalive Putty RDM: 855194; manufacturer code:16120

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing rate
Time Frame: 6-month
complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits.
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of antibiotic therapy
Time Frame: through study completion, an average of 1 year
systemic antibiotic therapy will be prescribed after intervention and its duration can vary according to infection state.
through study completion, an average of 1 year
Rate of recurrences
Time Frame: 6-months and 12-month
After intervention bone infections proper of osteomyelitis can recur
6-months and 12-month
Number of re-interventions because of the same lesion
Time Frame: through study completion, an average of 1 year
If an infection recur might be necessery to procede with a re-intervention.
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
If an infection recur might be necessery to procede with a re-intervention.
through study completion, an average of 1 year
Proportion of patients undergoing amputations
Time Frame: through study completion, an average of 1 year
In same severe cases minor or major amputations can be neccessary
through study completion, an average of 1 year
Patients' Quality of Life
Time Frame: 6-months and 12-month
The quality of life of patient will be evaluated using EQ-5D-5L from 0 (worse) to 100 (better)
6-months and 12-month
Patients' Quality of Life
Time Frame: 6-months and 12-month
The quality of life of patient will be evaluated with Foot Function Index from 0 (better) to 170 (worse)
6-months and 12-month
Time back to walk
Time Frame: through study completion, an average of 1 year
It will be registered when patients can go back to walk aftern the intervention
through study completion, an average of 1 year
Characteristics of surgery
Time Frame: intra-operative
data about characteristics (type) of surgeries will be collected
intra-operative
Length of surgery
Time Frame: intra-operative
data about the lenght (timing) of surgeries will be collected
intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Ovest Milanese

Collaborators

Hippocrates Research
Bonalive Biomaterials Ltd

Investigators

  • Principal Investigator: Dr. Roberto De Giglio, Med Doctor, ASST Ovest Milanese

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFORCT012023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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