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

Diabetic Foot Ulcer Clinical Trial

— TriO FITT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003400
• Other study ID #: TR-21-01
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: January 2025

Study information

• Verified date: August 2023
• Source: Tri.O Medical LTD
• Contact: Ronen Ben Ari
• Phone: +972525605209
• Email: Ronen[@]trio-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• 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).

Diagnostic Test:
• Physical Examination
physical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline.
• Vital Signs
vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.
• Hematology Blood Tests
complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,
• Biochemistry 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).
• Wound Digital Photography
3 photographs of the wound taken before wash, after wash and after treatment.
• Urine pregnancy test
for women with childbearing potential

Other:
• Numeric Pain Rating Scale
Numeric Pain Rating Scale - numeral scale from 1 to 10 measuring pain, 10 being worst pain.
• Visual Analogue Scale
Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.
• SF-36
SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.

Diagnostic Test:
• Wounds evaluation
including size measurements and visual description.

Locations

Country	Name	City	State
Israel	Hilel Yafe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Tri.O Medical LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by number of patients who lack adverse events throughout the study.		0 to 28 weeks
Primary	Change in pain level between visits 1 and the last treatment evaluated by VAS & NRS scales	pain levels will be measured by the precent of change in both pain raiting scales.	0 to 28 weeks
Primary	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.	0 to 28 weeks
Primary	Change in wound size between V1 and the last treatment	change in size (cm^2)	0 to 28 weeks