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

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

• Diabetic Foot Ulcer

Interventions

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.

DIAGNOSTIC_TEST

Vital Signs

vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.

DIAGNOSTIC_TEST

Hematology Blood Tests

complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

Wound Digital Photography

3 photographs of the wound taken before wash, after wash and after treatment.

DIAGNOSTIC_TEST

Urine pregnancy test

for women with childbearing potential

OTHER

Visual Analogue Scale

Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.

OTHER

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.

Sponsors & Collaborators

• Tri.O Medical LTD

  lead INDUSTRY

Principal Investigators

• Ronen Ben Ari · CEO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-29

Primary Completion

2025-12-31

Completion

2026-01-31

Countries

• Israel

Study Locations