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NCT03955289 Clinical Trial

Treatment of Foot and Leg Ulcers Using a Laser

Diabetic Foot Ulcer Clinical Trial

Official title:
Treatment of Foot and Leg Ulcers Using a Laser

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03955289
Other study ID # 2018-0270
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2019
Est. completion date February 1, 2019

Study information
Verified date July 2023
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date February 1, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States UT Southwestern Medical Center at Dallas Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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		 4 weeks
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Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
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Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A

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