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

Tri.O Medical Ltd

Status

Active, not recruiting

Conditions

Diabetic Foot Ulcer

Treatments

Diagnostic Test: Physical Examination

Diagnostic Test: Biochemistry Blood Test

Diagnostic Test: Urine pregnancy test

Device: Study treatment administration (TriO FITT)

Other: SF-36

Other: Visual Analogue Scale

Diagnostic Test: Wounds evaluation

Diagnostic Test: Vital Signs

Diagnostic Test: Hematology Blood Tests

Diagnostic Test: Wound Digital Photography

Study type

Interventional

Funder types

Industry

Identifiers

NCT06003400

TR-21-01

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Tri.O FITT

Experimental group

Description:

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.

Treatment: