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LASER Pilot Project

NCT05966636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Miami Dermatology and Laser Institute

    collaborator OTHER

  • Bruce W. Carter VA Medical Center

    collaborator UNKNOWN

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05966636 on ClinicalTrials.gov