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

> **NCT06003400** · NA · ACTIVE_NOT_RECRUITING · sponsor: **Tri.O Medical LTD** · enrollment: 20 (estimated)

## Conditions studied

- 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:** Visual Analogue Scale
- **OTHER:** SF-36
- **DIAGNOSTIC_TEST:** Wounds evaluation

## Key facts

- **NCT ID:** NCT06003400
- **Lead sponsor:** Tri.O Medical LTD
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-03-29
- **Primary completion:** 2025-12
- **Final completion:** 2026-01
- **Target enrollment:** 20 (ESTIMATED)
- **Last updated:** 2025-09-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06003400

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06003400, "Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients". Retrieved via AI Analytics 2026-08-11 from https://api.ai-analytics.org/clinical/NCT06003400. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*