Clinical trial NCT06003400: Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
Official title: Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Tri.O Medical LTD
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Administration of Tri.O FITT for upto 12 weeks or until wound closure.
Primary purpose: TREATMENT

Brief summary: The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers.

The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.


Eligibility 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

Primary outcomes:
measure: Safety measured by number of patients who lack adverse events throughout the study.
timeFrame: 0 to 28 weeks
measure: Change in pain level between visits 1 and the last treatment evaluated by VAS scale
timeFrame: 0 to 28 weeks
measure: Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36
timeFrame: 0 to 28 weeks
measure: Change in wound size between V1 and the last treatment
timeFrame: 0 to 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hilel Yafe Medical Center
Study officials:
affiliation: CEO
name: Ronen Ben Ari
role: STUDY_DIRECTOR
References: