No phaseCompleted
Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients (TriO FITT)
- Sponsor
- Tri.O Medical LTD (Industry)
- Enrolment
- 19 enrolled
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Study treatment administration (TriO FITT); Physical Examination; Vital Signs; Hematology Blood Tests; Biochemistry Blood Test; Wound Digital Photography; Urine pregnancy test; Visual Analogue Scale; SF-36; Wounds evaluation
- Ages
- adults, older adults
- Registry
- NCT06003400
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Safety measured by number of patients who lack adverse events throughout the study.
- Change in pain level between visits 1 and the last treatment evaluated by VAS scale
- Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36
- Change in wound size between V1 and the last treatment
History
Last registry update
Study completion
Primary completion
Registered
Started