ACTIVE_NOT_RECRUITING

LASER Pilot Project

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary InvestigationA

Quick Facts

Study Start:2024-02-01
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05966636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21-70 years.
  2. * Lower extremity amputation at the transtibial or transfemoral levels.
  3. * Lower extremity amputee who has regular and compliant use of a lower extremity prosthesis.
  4. * Lower extremity prosthesis use is disrupted or complicated by scarring and other skin maladies treatable with fractional CO2 laser therapy.
  5. * Cognitive ability to understand and willingness to provide informed consent and follow the study protocol.
  6. * Willing and able to attend pre and post procedural assessment sessions.
  7. * Willing and able to attend dermatologic and laser therapy sessions.
  1. * Does not have lower extremity amputation.
  2. * Lower extremity amputee who does not use a prosthesis.
  3. * Lower extremity prosthetic use is not disrupted due to scarring or other skin maladies.
  4. * Residual limb has an open wound or active infection.
  5. * Has any of the following; open residual limb wound, cultured epithelial autographts, active infection, presence of unstable epithelium within the early weeks of injury
  6. * Otherwise not a candidate for laser therapy.

Contacts and Locations

Principal Investigator

Jeffrey T Heckman, DO
PRINCIPAL_INVESTIGATOR
James A. Haley Veterans' Hospital, Tampa, FL

Study Locations (Sites)

Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jeffrey T Heckman, DO, PRINCIPAL_INVESTIGATOR, James A. Haley Veterans' Hospital, Tampa, FL

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

Study Start Date2024-02-01
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • Amputation
  • Scar
  • Fractional Ablative Laser Resurfacing

Additional Relevant MeSH Terms

  • Acquired Absence of Lower Limb
  • Scar Condition and Fibrosis of the Skin