Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X

Clinical Trial Summary

This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04207099
Study type	Observational
Source	MolecuLight Inc.
Contact	Liis Teene
Phone	416.542.5530
Email	lteene@moleculight.com
Status	Recruiting
Phase
Start date	February 14, 2020
Completion date	September 30, 2022

Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care — WAR

Clinical Trial Summary

Clinical Trial Description

Study Design

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