RECRUITING
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LASER Pilot Project
Veterans who use prosthetic limbs commonly suffer from skin problems such as scars that create discomfort and pain to the point that wearing the prosthesis is no longer tolerable. The Veteran must then discontinue prosthetic use to allow healing prior to wearing the limb again. Current treatments for skin problems include manual scar mobilization and massage, stretching, desensitization techniques, pain medication, prosthetic adjustment, steroid injection, scar excision and others. Most of these have not proven to be a long-term solution. A dermatologic procedure common in non-amputees for scar and skin lesion management, fractionated laser therapy, may be a long-term solution minimizing discomfort, pain and time out of the prosthesis. This preliminary study seeks to determine if fractional laser therapy can improve prosthetic use, and quality of life of Veterans with amputation who use lower limb prostheses.
Conditions:
🦠 Acquired Absence of Lower Limb 🦠 Scar Condition and Fibrosis of the Skin
🗓️ Study Start (Actual) 1 February 2024
🗓️ Primary Completion (Estimated) 31 January 2026
✅ Study Completion (Estimated) 31 January 2026
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Miami, Florida, United States
📍 Tampa, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 21-70 years.
    • * Lower extremity amputation at the transtibial or transfemoral levels.
    • * Lower extremity amputee who has regular and compliant use of a lower extremity prosthesis.
    • * Lower extremity prosthesis use is disrupted or complicated by scarring and other skin maladies treatable with fractional CO2 laser therapy.
    • * Cognitive ability to understand and willingness to provide informed consent and follow the study protocol.
    • * Willing and able to attend pre and post procedural assessment sessions.
    • * Willing and able to attend dermatologic and laser therapy sessions.

    Exclusion Criteria:

    • * Does not have lower extremity amputation.
    • * Lower extremity amputee who does not use a prosthesis.
    • * Lower extremity prosthetic use is not disrupted due to scarring or other skin maladies.
    • * Residual limb has an open wound or active infection.
    • * Has any of the following; open residual limb wound, cultured epithelial autographts, active infection, presence of unstable epithelium within the early weeks of injury
    • * Otherwise not a candidate for laser therapy.
Ages Eligible for Study: 21 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 July 2023
  • First Submitted that Met QC Criteria 25 July 2023
  • First Posted 28 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 February 2024
  • Last Update Posted 13 February 2024
  • Last Verified February 2024
I'm interested ...!!