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CompletedNCT03955289Updated Jul 24, 2023

Treatment of Foot and Leg Ulcers Using a Laser

An observational study in Diabetic Foot Ulcer, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Diabetic Foot Ulcer
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 34 is below the median of 100 across 186 observational studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients of the investigators with foot ulcers.

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

Exclusion Criteria:

  • not meeting inclusion criteria
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
34 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Improved healing rate to time to healing

    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.

    Time frame: 4 weeks

Secondary outcomes

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

    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

    Time frame: 4 weeks

07

Study locations

1 site
  • UT Southwestern Medical Center at Dallas
    Dallas, Texas 75390, United States
08

References and documents

Publications

  • Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum In: Diabetes Care. 2014 Sep;37(9):2660. PubMed 24186882 ↗
  • Teikemeier G, Goldberg DJ. Skin resurfacing with the erbium:YAG laser. Dermatol Surg. 1997 Aug;23(8):685-7. doi: 10.1111/j.1524-4725.1997.tb00389.x. PubMed 9256915 ↗
  • Mezzana P, Sonnino M, Madonna Terracina FS, Valeriani M. Treatment of atrophic scars with Er:YAG laser: our experience. Acta Chir Plast. 2001;43(1):26-8. PubMed 11370255 ↗
  • Wollina U, Konrad H, Karamfilov T. Treatment of common warts and actinic keratoses by Er:YAG laser. J Cutan Laser Ther. 2001 Jun;3(2):63-6. doi: 10.1080/146288301753377852. PubMed 11798495 ↗
  • Gurel MS, Aral BB. Effectiveness of erbium:YAG laser and cryosurgery in seborrheic keratoses: Randomized, prospective intraindividual comparison study. J Dermatolog Treat. 2015 Oct;26(5):477-80. doi: 10.3109/09546634.2015.1024597. Epub 2015 Mar 23. PubMed 25798694 ↗
  • Alsaad SM, Ross EV, Smith WJ, DeRienzo DP. Analysis of Depth of Ablation,Thermal Damage, Wound Healing, and Wound Contraction With Erbium YAG Laser in a Yorkshire Pig Model. J Drugs Dermatol. 2015 Nov;14(11):1245-52. PubMed 26580873 ↗
  • Madni TD, Lu KB, Imran JB, Clark AT, Hoopman JE, Kenkel JM, Phelan HA. Chronic burn wound treatment by Erbium: YAG fractional ablation: First described report and literature review. Burns. 2019 Feb;45(1):256-258. doi: 10.1016/j.burns.2018.10.001. Epub 2018 Oct 17. No abstract available. PubMed 30342793 ↗
  • Phillips TJ, Morton LM, Uebelhoer NS, Dover JS. Ablative Fractional Carbon Dioxide Laser in the Treatment of Chronic, Posttraumatic, Lower-Extremity Ulcers in Elderly Patients. JAMA Dermatol. 2015 Aug;151(8):868-71. doi: 10.1001/jamadermatol.2015.0645. PubMed 25946007 ↗
  • Krakowski AC, Diaz L, Admani S, Uebelhoer NS, Shumaker PR. Healing of chronic wounds with adjunctive ablative fractional laser resurfacing in two pediatric patients. Lasers Surg Med. 2016 Feb;48(2):166-9. doi: 10.1002/lsm.22398. Epub 2015 Aug 7. PubMed 26251161 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03955289
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Larry Lavery (Professor and Director of Research, University of Texas Southwestern Medical Center) — Principal investigator
First posted
May 20, 2019
Start date
Jan 15, 2019
Primary completion
Jan 30, 2019
Completion
Feb 1, 2019
Last update
Jul 24, 2023

Study contacts

Lawrence Lavery, DPM MPH
principal investigator · UT Southwestern Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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