Evaluating the FITT Device for Diabetic Foot Ulcers
Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
This study tests whether the TriO FITT device can help heal chronic diabetic foot ulcers in people who have had a single, non-infected ulcer for at least three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tri.O Medical LTD Industry-sponsored |
| Locations | 1 site (Hadera) |
| Trial ID | NCT06003400 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of the TriO FITT device in patients with chronic diabetic foot ulcers. The device aims to optimize and combine known supportive treatments to improve the healing of these wounds. Participants will undergo physical examinations, vital sign monitoring, and blood tests throughout the study. The trial focuses on patients with a single, non-infected diabetic ulcer that has been present for at least three months.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-80 with chronic diabetes and a single, hard-to-heal diabetic foot ulcer.
Not a fit: Patients with multiple wounds, severe obesity, or uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the healing process for patients suffering from chronic diabetic foot ulcers.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving wound healing in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females 18-80 years old * Chronic Diabetes Mellitus type 1 and type 2 diagnosed at least 3 years before the screening * Have a single non-infected diabetic hard-to-heal wound (ulcers/foot ulcers) ≤ 0.8-40 cm2 wound area at start of treatment, for period of at least for 3 months. * Wagner classification stage 1 or 2 or post-debridement stage 3. * At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) ≥0.65 * Stable diabetic drugs 4 weeks before Screening * Be available for the entire study period, and be able and willing to adhere to protocol requirements * Provide written informed consent prior to admission into the study Exclusion Criteria: * Have a glycosylated hemoglobin (HbA1c) \> 10.5% * Have more than one wound * Have a body mass index (BMI) \> 40 kg/m2 * Have visible bone exposure at wound site * Anemia (Hemoglobin \< 9 g/dL) or White Blood Cells count \> 11,000/μL or Platelets count \< 100,000/μL or liver function tests \> 3 times upper normal lab values or Creatinine \> 3 mg/dL; any indication of malnourishment (Albumin \< 3 g/dL); INR\>2 or any other clinically significant blood and urinalysis tests per the physician's discretion * Patients with unstable hypertension * Have any clinically significant chronic or acute illness during the 4 weeks prior to admission into the study, except diabetes type 1 or 2 or during screening period * Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years, not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test * Participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study * Patients with active Gangrenous foot ulcers * Active osteomyelitis (Have any signs of infection in the wound (which could be linked to raised body temperature), abscess, cellulitis, necrosis, erythema, mild drainage or known osteomyelitis) * Patients with uncontrolled hyperthyroidism * Patients with history of collagen diseases * Patients with known allergy to ozone * Anxiety, Depression, history of Mental illness or patient under Guardian * Any medical condition for which the investigator deems the subject unable to participate in the study
Where this trial is running
Hadera
- Hilel Yafe Medical Center — Hadera, Israel (Recruiting)
Study contacts
- Study coordinator: Ronen Ben Ari
- Email: Ronen@trio-medical.com
- Phone: +972525605209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.