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Treatment of Foot and Leg Ulcers Using a Laser

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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

Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 20, 2019
Last Update Posted Date May 20, 2019
Actual Study Start Date January 15, 2019
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 17, 2019)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Foot and Leg Ulcers Using a Laser
Official Title Treatment of Foot and Leg Ulcers Using a Laser
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.
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
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients of the investigators with foot ulcers.
Condition Diabetic Foot Ulcer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 17, 2019)
34
Original Actual Enrollment Same as current
Actual Study Completion Date February 1, 2019
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03955289
Other Study ID Numbers 2018-0270
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Larry Lavery, University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Lawrence Lavery, DPM MPH UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2019