Evaluating Surface Area Reduction Using MolecuLight Imaging Device

NCT03181568 | Unknown

• 1 other identifier: BTHFT 2159
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound; Wound Infection

Outcome Measures

Primary Outcomes (2)

• Change in wound measurements at various time-points through the study

  These measurements will be made using the MolecuLight quickSize measurement tool, which will be loaded onto the i:X device. Wound measurements will be made after any wound cleaning and/or debridement, as per standard practice.

  At baseline, 2nd, 4th, 6th, 8th, 10th and 12th week of the study

• Change in wound characteristics at various time-points through the study

  Wound characteristics will be noted using the Bates-Jensen Wound Assessment score tool

  at baseline, 2, 4, 6, 8, 10 and 12 weeks

Study Arms (2)

Control

OTHER

This arm group (control) will receive standard wound care of chronic wounds

Procedure: Wound care

Treatment

OTHER

The treatment arm of the study will utilize the MolecuLight i:X Imaging Device to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present

Device: MolecuLight i:X™ Imaging Device

Interventions

MolecuLight i:X™ Imaging Device DEVICE

Offers real-time detection of important biological and molecular information of a wound. The MolecuLight i:X Imaging Device is intended to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device can capture and document either an image or video of the wound where the presence of fluorescent 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.

Treatment

Wound care PROCEDURE

Standard wound care of chronic wounds e.g. sampling, debridement, infection control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• having a chronic wound that is not a diabetic foot ulcer
• presence of the wound for ≥ 6 weeks and ≤ 2 years.
• wound size surface area ≥ 2 cm2 and ≤ 50 cm2.
• Willingness to comply with prescribed wound care regimen

You may not qualify if:

• candidate for surgery in the next 12 weeks
• a wound with necrotic tissue unable to tolerate debridement
• uncontrolled diabetics (defined as HbA1c of \>85.5mmol/mol)
• presence of a diabetic foot ulcer
• currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion)
• women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control
• participation in another investigative drug or device trial currently or within the last 30 days

Sponsors & Collaborators

• Calver Pang: lead

Study Sites (1)

Bradford Teaching Hospitals NHS Trust

Bradford, BD96RJ, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries; Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigator will be blinded to study Clinical staff that will evaluate wounds at baseline, 2, 4, 6, 8, 10 and 12 weeks after date of randomisation and therapy initiation will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: This will be a single blinded randomised trial where the control group will be receiving a standard wound care whereas the treatment group would also be receiving standard wound care but under the guidance of the imaging device.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 9, 2017
• Study Start: July 10, 2017
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)