LASER Pilot Project

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT05966636

Run by

VA Office of Research and Development

People needed

10

Starts

2024-02-01

Expected to finish

2026-01-31

Last updated by the study team

2026-04-21

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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