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Completed

NCT Number: NCT03955289

Treatment of Foot and Leg Ulcers Using a Laser

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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 20, 2019
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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