Diabetic Foot UlcerNCT03955289
Treatment of Foot and Leg Ulcers Using a Laser
An observational study of Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the investigators with foot ulcers.
Who may be able to join
- patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic starting on May 17, 2018 to November 13, 2018
Who cannot join
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
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.
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).
- Conditions
- Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 Jan 2019
- Primary completion30 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Lavery, University of Texas Southwestern Medical Center
- Investigators
- Lawrence Lavery, DPM MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955289
- Sponsor's protocol ID
- 2018-0270
- Status last verified
- Jul 2023
- First submitted
- 16 May 2019
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24186882Teikemeier 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 9256915Mezzana 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 11370255Wollina 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 11798495Gurel 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 25798694Alsaad 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 26580873Madni 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 30342793Phillips 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 25946007Krakowski 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Foot and Leg Ulcers Using a Laser
- ClinicalTrials.gov ID
- NCT03955289
- Acronym / sponsor ID
- 2018-0270
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the investigators with foot ulcers.
Key inclusion criteria (1 listed)
- patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic starting on May 17, 2018 to November 13, 2018
Key exclusion criteria (1 listed)
- not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Decreased complications in diabetic foot ulcers, i.e. infection, hospital admission, amputation
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 24186882Rice 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.
- Background: PubMed 9256915Teikemeier 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.
- Background: PubMed 11370255Mezzana 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.
- Background: PubMed 11798495Wollina 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.
- Background: PubMed 25798694Gurel 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.
- Background: PubMed 26580873Alsaad 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.
- Background: PubMed 30342793Madni 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.
- Background: PubMed 25946007Phillips 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.
- Background: PubMed 26251161Krakowski 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.
- 2\. Sciton Inc. (n.d.). \[Brochure\]. Author. Retrieved November 8, 2018Link provided by the sponsor.
- Wollina, Uwe. (2016). Erbium-YAG laser therapy - analysis of more than 1,200 treatments. Journal of Global Dermatology. 3. 10.15761/GOD.1000171Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Lavery, DPM MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved healing rate to time to healing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955289, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.