Non-Healing Ulcer of SkinNCT06068972
Retrospective Database Review at LTC and SNFs
An observational study of Non-Healing Ulcer of Skin and Autofluorescence Imaging, run by Wound Care Plus, LLC at 1 site in United States.
Trial summary
The goal of this observational study is to compare the differences in wound outcomes when the MolecuLight imaging procedure is used in combination with standard of care wound assessment in long term care and skilled nursing facilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Healing Ulcer of Skin, Autofluorescence Imaging
- What is being tested?
- MolecuLight
- Type of treatment
- Medical device
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to 19 Jun 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult Medicare beneficiaries in the state of Missouri who began receiving wound care (admission period) from Wound Care Plus LLC providers during time periods from Jan 2019-Feb 2020 (standard of care cohort) and May 2021-March 2022 (Moleculight cohort).
Who may be able to join
- Were first treated by Wound Care Plus LLC during time periods from Jan 2019-Feb 2020 (standard of care cohort) and May 2021-Mar 2022 (Moleculight cohort)
- Received at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period
- Were treated by a Wound Care Plus LLC provider for at least 4 calendar weeks during the study period
- Were treated in a SNF or LTC setting during the study admission period
- Were covered by Medicare of Missouri during the study admission period
- Had at least one chronic ulcer with ICD-10 diagnosis codes L89, L97, L98, or L97/L98 in combination with E11 during the study admission period
- MolecuLight cohort ONLY: at least one MolecuLight imaging procedure during the study admission period, indicated by CPT code 0598T
Who cannot join
- Did not receive at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period
- Received care from Wound Care Plus LLC for less than 4 calendar weeks during the study admission period
- Were not treated in a SNF or LTC setting during the study admission period
- Were not covered by Medicare of Missouri during the study admission period
- Did not have a chronic ulcer with ICD-10 diagnosis codes L89, L97, L98, or L97/L98 in combination with E11 during the study admission period
- MolecuLight cohort ONLY: did not receive a MolecuLight imaging procedure during the study admission period, indicated by CPT code 0598T
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Database Analysis of the Impact of Fluorescence Imaging of Bacterial Presence, Location, and Load on Wound Healing, Antibiotic Usage, and Infection Related Complications
The goal of this observational study is to compare the differences in wound outcomes when the MolecuLight imaging procedure is used in combination with standard of care wound assessment in long term care and skilled nursing facilities. The main outcome studied is healing of ulcers after 12-weeks, along with other outcomes such as occurrence of infection, complications, and antimicrobial use. Medical records from the past were reviewed, where patients receiving the MolecuLight procedure were compared to those who did not.
- Being tested
- MolecuLight
- Keywords
- chronic wounds, bacterial loads, fluorescence imaging, MolecuLight, long-term care, skilled nursing facility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLightDevice
Also called Autofluorescence imaging
Point-of-care fluorescence imaging of high bacterial loads
| Study group | Role | What they receive |
|---|---|---|
| MolecuLight cohort | The MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment. Receives: Device: MolecuLight | |
| Standard of Care cohort | Standard of care clinical wound assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of wounds healed
Measured: 12-weeks
Time to healing among wounds healed during study period
Measured: 2019-2022
Secondary outcomes (1)
Occurrence of wound-related infection, infection complications, antimicrobial use over the study period
Measured: 2019-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start20 Apr 2022
- Primary completion12 Jul 2022
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Healing Ulcer of SkinStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wound Care Plus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068972
- Sponsor's protocol ID
- 22-001
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To protect patient confidentiality, the study data are not publicly available; however they are available from the authors upon reasonable request and with permission of Wound Care Plus, LLC.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Database Analysis of the Impact of Fluorescence Imaging of Bacterial Presence, Location, and Load on Wound Healing, Antibiotic Usage, and Infection Related Complications
- ClinicalTrials.gov ID
- NCT06068972
- Acronym / sponsor ID
- 22-001
- Keywords
- chronic wounds, bacterial loads, fluorescence imaging, MolecuLight, long-term care, skilled nursing facility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Wound Care Plus, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 5 Oct 2023 (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.
The goal of this observational study is to compare the differences in wound outcomes when the MolecuLight imaging procedure is used in combination with standard of care wound assessment in long term care and skilled nursing facilities. The main outcome studied is healing of ulcers after 12-weeks, along with other outcomes such as occurrence of infection, complications, and antimicrobial use. Medical records from the past were reviewed, where patients receiving the MolecuLight procedure were compared to those who did not.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MolecuLight cohort | – | Device: MolecuLightThe MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment. |
| Standard of Care cohort | – | –Standard of care clinical wound assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Medicare beneficiaries in the state of Missouri who began receiving wound care (admission period) from Wound Care Plus LLC providers during time periods from Jan 2019-Feb 2020 (standard of care cohort) and May 2021-March 2022 (Moleculight cohort).
Key inclusion criteria (7 listed)
- Were first treated by Wound Care Plus LLC during time periods from Jan 2019-Feb 2020 (standard of care cohort) and May 2021-Mar 2022 (Moleculight cohort)
- Received at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period
- Were treated by a Wound Care Plus LLC provider for at least 4 calendar weeks during the study period
- Were treated in a SNF or LTC setting during the study admission period
- Were covered by Medicare of Missouri during the study admission period
Key exclusion criteria (6 listed)
- Did not receive at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period
- Received care from Wound Care Plus LLC for less than 4 calendar weeks during the study admission period
- Were not treated in a SNF or LTC setting during the study admission period
- Were not covered by Medicare of Missouri during the study admission period
- Did not have a chronic ulcer with ICD-10 diagnosis codes L89, L97, L98, or L97/L98 in combination with E11 during the study admission period
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 |
|---|---|---|
| MolecuLightAlso: Autofluorescence imagingPoint-of-care fluorescence imaging of high bacterial loads | Device | MolecuLight cohort |
Primary outcome
Proportion of wounds healed
Time frame: 12-weeks
Time to healing among wounds healed during study period
Time frame: 2019-2022
1 secondary outcome
Occurrence of wound-related infection, infection complications, antimicrobial use over the study period
Time frame: 2019-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No. To protect patient confidentiality, the study data are not publicly available; however they are available from the authors upon reasonable request and with permission of Wound Care Plus, LLC.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Healing Ulcer of Skin and Autofluorescence Imaging, run by Wound Care Plus, LLC at 1 site in United States.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 5 Oct 2023. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of wounds healed (time frame: 12-weeks). 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 5 Oct 2023.