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COMPLETED
NCT05966636
NA

LASER Pilot Project

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

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 Investigation

Key Details

Gender

All

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-02-01

Completion Date

2026-01-31

Last Updated

2026-04-21

Healthy Volunteers

Yes

Interventions

PROCEDURE

Fractional CO2 Laser Ablative Resurfacing

Fractional lasers stimulate scar improvement through production of microscopic patterns of dermal injury, vaporizing scar tissue and inducing neocollagenesis, subsequently improving scar tissue texture and range of motion, and decreasing symptoms such as pain and pruritis. Current clinical consensus is supportive that fractionated lasers are the most effective option for the treatment of scars. Other laser wavelengths and modalities used for vascular deformities and hair removal for instance, have an adjunctive role in improving scars and may be used in the same laser session. Case reports provide evidence of substantial improvement in sensory symptoms and physical mobility within days to weeks after each treatment.

Locations (2)

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States