Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 9:19 AM
Study NCT ID:
NCT03181568
Status:
UNKNOWN
Last Update Posted:
2017-06-09
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Surface Area Reduction Using MolecuLight Imaging Device
Sponsor:
Calver Pang
Organization:
Study Overview
Official Title:
A 12-week, Single-blind, Prospective, Randomized, Controlled, Pilot Clinical Trial to Evaluate Surface Area Reduction With Use of the MolecuLight i:X™ Imaging Device Compared to Standard Treatment of Chronic Wounds
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
12-week single-blind, prospective, randomized, controlled, pilot clinical trial assessing The MolecuLight i:X Imaging Device in chronic wounds. This device guides clinicians to inspect, sample, debride or further evaluate areas within or around a wound where potentially harmful bacteria appear under violet light illumination resulting in better overall care and accelerated surface area reduction compared to current standard care. The study aims to determine if this device aids in the healing of chronic wounds by reduction in size of wound compared to current standard of care.
Detailed Description:
This is a prospective, 12-week, single-blinded, randomized, controlled clinical trial has been designed with two primary objectives needed to inform more comprehensive studies at a later date. We propose to evaluate the following two primary outcomes: (1) the ability of the MolecuLight i:X Imaging Device to predict non healing wounds and wounds at risk or infection (control arm) and (2) whether utilization of the MolecuLight i:X Imaging Device in guiding clinicians to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present (treatment arm) increases wound healing rates relative to standard care (control arm) for the treatment of chronic wounds.
Both arms will receive standard procedures associated with wound care (e.g., sampling, debridement, preventative care, infection control, etc.) according to best practice guidelines. Patients will be randomly assigned to either the control or treatment arm and be followed as per the study protocol every time their wound is cared for over a 12-week period. The effectiveness of the MolecuLight i:X Imaging Device will be assessed with evaluation of wound surface area reduction rate and infection rates (incidence of infection and time to eradicate infection) compared to standard care.
All subjects randomized will be evaluated for 12 weeks from the date of enrollment and treatment initiation. Subjects who may have wound closure within the 12-week study period will continue to have scheduled study evaluation visits up to the end of week 12.
Both arms will receive standard procedures associated with wound care (e.g., sampling, debridement, preventative care, infection control, etc.) according to best practice guidelines. Patients will be randomly assigned to either the control or treatment arm and be followed as per the study protocol every time their wound is cared for over a 12-week period. The effectiveness of the MolecuLight i:X Imaging Device will be assessed with evaluation of wound surface area reduction rate and infection rates (incidence of infection and time to eradicate infection) compared to standard care.
All subjects randomized will be evaluated for 12 weeks from the date of enrollment and treatment initiation. Subjects who may have wound closure within the 12-week study period will continue to have scheduled study evaluation visits up to the end of week 12.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: