NCT03955289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

15 days

First QC Date

May 16, 2019

Last Update Submit

July 20, 2023

Conditions

Diabetic Foot Ulcer

Outcome Measures

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.

    4 weeks

Secondary Outcomes (1)

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

    4 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the investigators with foot ulcers.

You may qualify if:

  • patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic starting on May 17, 2018 to November 13, 2018

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (9)

  • 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.

    PMID: 24186882BACKGROUND

  • 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.

    PMID: 9256915BACKGROUND

  • 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.

    PMID: 11370255BACKGROUND

  • 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.

    PMID: 11798495BACKGROUND

  • 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.

    PMID: 25798694BACKGROUND

  • 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.

    PMID: 26580873BACKGROUND

  • 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.

    PMID: 30342793BACKGROUND

  • 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.

    PMID: 25946007BACKGROUND

  • 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.

    PMID: 26251161BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Lawrence Lavery, DPM MPH

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director of Research

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 20, 2019

Study Start

January 15, 2019

Primary Completion

January 30, 2019

Study Completion

February 1, 2019

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)