Diabetic Foot UlcerTriO FITTNCT06003400
Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
A study testing Study treatment administration (TriO FITT), Physical Examination and Vital Signs in people with Diabetic Foot Ulcer, run by Tri.O Medical LTD at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Study treatment administration (TriO FITT), Physical Examination and Vital Signs
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Mar 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Diabetic Foot Ulcer
- Being tested
- Study treatment administration (TriO FITT), Physical Examination, Vital Signs, Hematology Blood Tests, Biochemistry Blood Test
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study treatment administration (TriO FITT)Device
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).
Physical ExaminationDiagnostic test
physical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline.
Vital SignsDiagnostic test
vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.
Hematology Blood TestsDiagnostic test
complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,
Biochemistry Blood TestDiagnostic 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).
Wound Digital PhotographyDiagnostic test
3 photographs of the wound taken before wash, after wash and after treatment.
Urine pregnancy testDiagnostic test
for women with childbearing potential
Visual Analogue ScaleOther
Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.
SF-36Other
SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.
Wounds evaluationDiagnostic test
including size measurements and visual description.
| Study group | Role | What they receive |
|---|---|---|
| Tri.O FITT | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by number of patients who lack adverse events throughout the study.
Measured: 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.
Measured: 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.
Measured: 0 to 28 weeks
Change in wound size between V1 and the last treatment
change in size (cm^2)
Measured: 0 to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start29 Mar 2023
- Primary completion23 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Administration of Tri.O FITT for upto 12 weeks or until wound closure.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri.O Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronen Ben Ari, Study director, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003400
- Sponsor's protocol ID
- TR-21-01
- Acronym
- TriO FITT
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
- ClinicalTrials.gov ID
- NCT06003400
- Acronym / sponsor ID
- TriO FITT / TR-21-01
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Tri.O Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 23 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Administration of Tri.O FITT for upto 12 weeks or until wound closure.
| Arm | Type | Receives |
|---|---|---|
| Tri.O FITT | Experimental | 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 evaluationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 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). | Device | Tri.O FITT |
| Physical Examinationphysical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline. | Diagnostic test | Tri.O FITT |
| Vital Signsvital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight. | Diagnostic test | Tri.O FITT |
| Hematology Blood Testscomplete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen, | Diagnostic test | Tri.O FITT |
| Biochemistry Blood Testurea, 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 test | Tri.O FITT |
| Wound Digital Photography3 photographs of the wound taken before wash, after wash and after treatment. | Diagnostic test | Tri.O FITT |
| Urine pregnancy testfor women with childbearing potential | Diagnostic test | Tri.O FITT |
| Visual Analogue ScaleVisual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain. | Other | Tri.O FITT |
| SF-36SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life. | Other | Tri.O FITT |
| Wounds evaluationincluding size measurements and visual description. | Diagnostic test | Tri.O FITT |
Primary outcome
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
Time frame: 0 to 28 weeks
pain levels will be measured by the precent of change in VAS pain raiting scale.
Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36
Time frame: 0 to 28 weeks
score measures from 0 to 100, 100 being good quality of life.
Change in wound size between V1 and the last treatment
Time frame: 0 to 28 weeks
change in size (cm^2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronen Ben Ari study director
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study treatment administration (TriO FITT), Physical Examination and Vital Signs in people with Diabetic Foot Ulcer, run by Tri.O Medical LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by number of patients who lack adverse events throughout the study. (time frame: 0 to 28 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.