LASER Pilot Project

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

LASER Pilot Project

Condition
Acquired Absence of Lower Limb
Intervention / Treatment

-

Contacts and Locations

Miami

Miami VA Healthcare System, Miami, FL, Miami, Florida, United States, 33125

Tampa

James A. Haley Veterans' Hospital, Tampa, FL, Tampa, Florida, United States, 33612

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

VA Office of Research and Development,

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

Study Record Dates

2026-01-31