Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Foot and Leg Ulcers Using a Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03955289
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Larry Lavery, University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease
Diabetic Foot Ulcer

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Treatment of Foot and Leg Ulcers Using a Laser
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the investigators with foot ulcers.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955289


Locations
Layout table for location information
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Lawrence Lavery, DPM MPH UT Southwestern Medical Center

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03955289     History of Changes
Other Study ID Numbers: 2018-0270
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Ulcer
Diabetic Foot
Foot Ulcer
Leg Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases