NCT06003400

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tri.O Medical LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2023-08-22
• Last updated: 2025-09-11

Locations

1 site across 1 country: Israel