NCT04163055: FLIGHT

Fluorescence Image-Guided Healing Trial

Status unknown Phase 4 Last updated 3 November 2020

What this trial tests

Phase 4 trial testing Moleculight i:X in Diabetic Foot Ulcer in 294 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
30 December 2022

31 December 2022

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	294
Start date	1 January 2021
Primary completion	30 December 2022
Estimated completion	31 December 2022

Drugs / interventions tested

• Moleculight i:X

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lower extremity complications such as chronic diabetic foot ulcers (DFUs) are a major risk for Type I/II diabetes patients. Minor injuries that would normally heal without consequence in non-diabetic individuals are at greater risk of bacterial infection and progression to non healing (chronic) wound status in diabetics, largely due to a loss of sensation in limbs (neuropathy) and decreased blood flow (vascular disease). If not treated efficiently and effectively, DFUs can have serious complications e.g. amputation, sepsis and death. The investigators propose to address this significant unmet clinical need using a novel commercial handheld fluorescence imaging product called the MolecuLight i:X (MolecuLight Inc.) which images clinically-significant wound bacteria without contrast agents or patient contact. Evidence in animal models of chronic wounds and multiple published clinical trials (mainly DFUs) have shown significant clinical potential for fluorescence imaging to detect potentially harmful bacteria in wounds otherwise invisible to doctors. The investigators have shown that clinicians can easily, objectively and more accurately determine the likelihood of bacterial infection than the standard of care. Moreover, published clinical evidence has shown fluorescence imaging enables more accurate microbial wound sampling and guides more targeted debridement of wounds to reduce bacteria levels. Our pilot data also show that when used like this, the i:X device accelerates DFU wound healing, compared with current methods. Thus, the investigators propose to expand the current pilot studies through a statistically-powered 3 y randomized controlled trial to test the therapeutic benefit of fluorescence-guided treatment for DFUs in a larger group of patients. A successful trial could help reduce DFU healing times compared with standard practice (using a new Canadian product) and improve patient quality of life, reduce amputation risk and alleviate health care costs for diabetes complications in Canada and beyond.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.