Retrospective Database Review at LTC and SNFs

Completed

• Conditions: Non-Healing Ulcer of Skin; Autofluorescence Imaging
• Interventions: Device: MolecuLight

• Registration Number: NCT06068972
• Lead Sponsor: Wound Care Plus, LLC

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-20
• Primary Completion: 2022-07-12
• Study Completion: 2023-06-19
• Status Verified: 2023-09
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MolecuLight cohort	MolecuLight	The MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment.

Primary Outcome Measures

Name	Time	Method
Proportion of wounds healed	12-weeks
Time to healing among wounds healed during study period	2019-2022

Secondary Outcome Measures

Name	Time	Method
Occurrence of wound-related infection, infection complications, antimicrobial use over the study period	2019-2022

Trial Locations

Locations (1)

Wound Care Plus, LLC; 🇺🇸 Blue Springs, Missouri, United States