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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: 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: Numeric Pain Rating Scale; Other: Visual Analogue Scale; Other: SF-36; Diagnostic Test: Wounds evaluation

• Registration Number: NCT06003400
• Lead Sponsor: Tri.O Medical LTD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tri.O FITT	Physical Examination	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.
Tri.O FITT	Urine pregnancy test	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.
Tri.O FITT	SF-36	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.
Tri.O FITT	Hematology Blood Tests	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.
Tri.O FITT	Biochemistry Blood Test	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.
Tri.O FITT	Numeric Pain Rating Scale	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.
Tri.O FITT	Visual Analogue Scale	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.
Tri.O FITT	Study treatment administration (TriO 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.
Tri.O FITT	Vital Signs	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.
Tri.O FITT	Wound Digital Photography	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.
Tri.O FITT	Wounds evaluation	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.

Primary Outcome Measures

Name	Time	Method
Safety measured by number of patients who lack adverse events throughout the study.	0 to 28 weeks
Change in pain level between visits 1 and the last treatment evaluated by VAS scale	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	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	0 to 28 weeks	change in size (cm\^2)

Trial Locations

Locations (1)

Hilel Yafe Medical Center; 🇮🇱 Hadera, Israel