Treatment of Foot and Leg Ulcers Using a Laser

July 20, 2023 updated by: Larry Lavery, University of Texas Southwestern Medical Center
The investigators plan to do a retrospective chart review on patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic.

Study Overview

Status

Completed

Conditions

Detailed Description

The investigators plan to do a retrospective chart review on patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic starting on May 17, 2018 to November 13, 2018. The investigators chose this date because that is the first time laser treatments were performed in the clinic. The investigators will collect the following data points:

  • Ulcer etiology
  • Ulcer location
  • Prior ulcer treatment type and duration, and wound measurements/characteristics
  • Wound size 4-6 weeks prior to laser treatment; at treatment time; and then each follow up measurement healed or x weeks
  • eGFR
  • Albumin
  • Last A1c-Presence/absence of DM
  • Amputation history
  • Vascular status via ABI's
  • Identify comorbidities
  • Identify associated encounters in the patients such as complications (i.e. infection), related readmissions The investigators will identify this information from patient charts (EPIC EMR).

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of the investigators with foot ulcers.

Description

Inclusion Criteria:

  • patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic starting on May 17, 2018 to November 13, 2018

Exclusion Criteria:

  • not meeting inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved healing rate to time to healing
Time Frame: 4 weeks
Wounds assessed in this study will show significant improvement in wound characteristics after Erbium-YAG laser debridement(s). Improved healing rate to time to healing.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased complications in diabetic foot ulcers, i.e. infection, hospital admission, amputation
Time Frame: 4 weeks

Wounds assessed in this study will show significant improvement in wound characteristics after Erbium-YAG laser debridement(s).

Decreased complications in diabetic foot ulcers, i.e. infection, hospital admission, amputation
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Lawrence Lavery, DPM MPH, UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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