Treatment of Foot and Leg Ulcers Using a Laser

Completed

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT03955289
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-01-15
• Primary Completion: 2019-01-30
• Study Completion: 2019-02-01
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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Exclusion Criteria

• not meeting inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved healing rate to time to healing	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

Name	Time	Method
Decreased complications in diabetic foot ulcers, i.e. infection, hospital admission, amputation	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

Trial Locations

Locations (1)

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States