Active, not recruitingNCT06003400TriO FITTUpdated Sep 11, 2025

Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients

An interventional study of Study treatment administration (TriO FITT) and Physical Examination in Diabetic Foot Ulcer, sponsored by Tri.O Medical LTD. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Tri.O Medical LTD · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Registered 3 months after the study started (first participant enrolled Mar 2023, registered Jul 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Diabetic Foot Ulcer

Browse trials for

Diabetic Foot 1,054

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.

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Lead sponsor

This is the only study on the registry with Tri.O Medical LTD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
Tri.O FITT
The study patients will undergo a screening period of upto 4 weeks, a traetment period of upto 12 weeks and a follow-up period of upto 12 additional weeks.
Device: Study treatment administration (TriO FITT) · Diagnostic Test: Physical Examination · Diagnostic Test: Vital Signs · Diagnostic Test: Hematology Blood Tests · Diagnostic Test: Biochemistry Blood Test · Diagnostic Test: Wound Digital Photography · Diagnostic Test: Urine pregnancy test · Other: Visual Analogue Scale · Other: SF-36 · Diagnostic Test: Wounds evaluation

Interventions

DeviceStudy treatment administration (TriO FITT)
Patients will be treated with the study device 2-3 times per week (determined by their wagner score) for an hour at each visit. treatment will include a combination of methods (the exact details is patented by the company and can not be elaborated).
Diagnostic testPhysical Examination
physical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline.
Diagnostic testVital Signs
vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.
Diagnostic testHematology Blood Tests
complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,
Diagnostic testBiochemistry Blood Test
urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides).
Diagnostic testWound Digital Photography
3 photographs of the wound taken before wash, after wash and after treatment.
Diagnostic testUrine pregnancy test
for women with childbearing potential
OtherVisual Analogue Scale
Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.
OtherSF-36
SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.
Diagnostic testWounds evaluation
including size measurements and visual description.

What researchers measure

Primary outcomes

Safety measured by number of patients who lack adverse events throughout the study.
Time frame: 0 to 28 weeks
Change in pain level between visits 1 and the last treatment evaluated by VAS scale
pain levels will be measured by the precent of change in VAS pain raiting scale.
Time frame: 0 to 28 weeks
Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36
score measures from 0 to 100, 100 being good quality of life.
Time frame: 0 to 28 weeks
Change in wound size between V1 and the last treatment
change in size (cm\^2)
Time frame: 0 to 28 weeks

Study locations

1 site

Hilel Yafe Medical Center
Hadera, Israel

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06003400
Lead sponsor: Tri.O Medical LTD
Responsible party: Sponsor
First posted: Aug 22, 2023
Start date: Mar 29, 2023
Primary completion: Dec 2025 (estimated)
Completion: Jan 2026 (estimated)
Last update: Sep 11, 2025

Study contacts

Ronen Ben Ari

study director · CEO

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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