Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds

NCT02682069 | Completed Results

• 1 other identifier: 16-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (punch biopsy method).

Conditions

Wounds

Keywords

Diabetic foot ulcer; venous leg ulcer; fluorescence imaging; wound imaging

Outcome Measures

Primary Outcomes (1)

• Positive Predictive Value (PPV) - Ability of Fluorescence Imaging With the MolecuLight i:X to Predict Presence of Bacterial Loads of 104 CFU/g and Greater

  PPV reflects the probability that a region of red fluorescence within or around a wound will contain bacteria. Meaning the number cases where qPCR analysis of wound tissue biopsies from red fluorescent region showed to have pathogen load ≥ 104 CFU/g divided by the total number of cases where red florescence was observed in the wound multiplied by 100,

  Baseline

Study Arms (1)

All patients

EXPERIMENTAL

There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.

Device: MolecuLight i:X Imaging Device

Interventions

MolecuLight i:X Imaging Device DEVICE

The intended use of the device is to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device will be used as part of the current clinical wound assessment process which may include examination for characteristic signs and symptoms of infection. The device can capture and document either an image or video of the chronic wound where the presence of florescent bacteria appears under violet light illumination. This information can be used to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients presenting with chronic wound of the lower limb (e.g. diabetic foot ulcer, venous leg ulcer, other acceptable aetiology)
• years or older

You may not qualify if:

• Treatment with an investigational drug within 1 month before study enrolment
• Use of systemic (oral or intravenous) antibiotics
• Inability to consent
• Any contra-indication to routine wound care and/or monitoring

Sponsors & Collaborators

• MolecuLight Inc.: lead
• Southwest Regional Wound Care Center: collaborator

Related Publications (1)

• Rennie MY, Lindvere-Teene L, Tapang K, Linden R. Point-of-care fluorescence imaging predicts the presence of pathogenic bacteria in wounds: a clinical study. J Wound Care. 2017 Aug 2;26(8):452-460. doi: 10.12968/jowc.2017.26.8.452.

  PMID: 28795890 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Results Point of Contact

• Title: Liis Teene
• Organization: MolecuLight Inc.

lteene@moleculight.com

416.542.5530

Study Officials

• Ron Wolcott, MD

  Southwest Regional Wound Care Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 15, 2016
• Study Start: February 1, 2016
• Primary Completion: January 5, 2017
• Study Completion: August 30, 2017
• Last Updated: February 26, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share