WoundNCT03181568
Evaluating Surface Area Reduction Using MolecuLight Imaging Device
A study testing MolecuLight i:X™ Imaging Device and Wound care in people with Wound and Wound Infection, run by Calver Pang at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound, Wound Infection
- What is being tested?
- MolecuLight i:X™ Imaging Device and Wound care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2017to 29 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bradford Teaching Hospitals NHS Trust
Bradford, BD96RJ
Calver Pang, MBChB, 07799060368, calverpang@doctors.org.uk
Jane Dennison, 01274382575, jane.dennison@bthft.nhs.uk
About this study
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
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.
Read the 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.
- Conditions
- Wound, Wound Infection
- Being tested
- MolecuLight i:X™ Imaging Device, Wound care
- Medical subject headings
- Wounds and Injuries, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLight i:X™ Imaging DeviceDevice
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.
Wound careProcedure or surgery
Standard wound care of chronic wounds e.g. sampling, debridement, infection control
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | This arm group (control) will receive standard wound care of chronic wounds Receives: 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 Receives: Device: MolecuLight i:X™ Imaging Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at baseline, 2, 4, 6, 8, 10 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start10 Jul 2017 (estimated)
- Primary completion29 Sep 2017 (estimated)
- Study completion29 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calver Pang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Calver Pang, Bradford Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181568
- Sponsor's protocol ID
- BTHFT 2159
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03181568
- Acronym / sponsor ID
- BTHFT 2159
- Conditions
- Wound, Wound Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Calver PangOther government
- Study start
- 10 Jul 2017 (estimated)
- Primary completion
- 29 Sep 2017 (estimated)
- Study completion
- 29 Sep 2017 (estimated)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Wound careThis arm group (control) will receive standard wound care of chronic wounds |
| Treatment | Other | Device: MolecuLight i:X™ Imaging DeviceThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MolecuLight i:X™ Imaging DeviceOffers 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. | Device | Treatment |
| Wound careStandard wound care of chronic wounds e.g. sampling, debridement, infection control | Procedure or surgery | Control |
Primary outcome
Change in wound measurements at various time-points through the study
Time frame: At baseline, 2nd, 4th, 6th, 8th, 10th and 12th week of 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.
Change in wound characteristics at various time-points through the study
Time frame: at baseline, 2, 4, 6, 8, 10 and 12 weeks
Wound characteristics will be noted using the Bates-Jensen Wound Assessment score tool
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MolecuLight i:X™ Imaging Device and Wound care in people with Wound and Wound Infection, run by Calver Pang at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound measurements at various time-points through the study (time frame: At baseline, 2nd, 4th, 6th, 8th, 10th and 12th week of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.