NCT05966636|Completed
LASER Pilot Project
LASER
The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary Investigation
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LASER
The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary Investigation
Sponsor study identifier
Secondary identifiers
interventional
10
1 country
2
Study Start
February 1, 2024
Actual (reported)Primary Completion
January 31, 2026
Actual (reported)Study Completion
January 31, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 18, 2023
Actual (reported)July 28, 2023
Actual (reported)February 1, 2024
Actual (reported)January 31, 2026
Actual (reported)January 31, 2026
Actual (reported)Change in Prosthesis Evaluation Questionnaire
Patient Reported Outcome Measure with score from 0-100 with increased score demonstrated patient reported improvement
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in 2 minute walk test
Functional performance with score from 0 - 999 feet with increased score demonstrating increased velocity in walking
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in The Patient and Observer Scar Assessment Scale
Dermatologic Survey on a scale of 1-10 with increased number demonstrating worsening of scar appearance
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Optical Coherence Tomography
Observational Measure for documentation of scar characteristics
All subjects will have scars, quality of life, function assessed pre and post laser treatment
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125, United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612, United States
Jeffrey T Heckman, DO
James A. Haley Veterans' Hospital, Tampa, FL
10 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2023
First Posted
July 28, 2023
Study Start
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Manchester Scar Scale
Dermatologic survey on a scale of 1-4 with higher numbers representing worsening of conditions of scar
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Dermatology Life Quality Index
Dermatologic survey using a scale from scar problems resulting in very much, a lot, a little or not at all impacts to quality of life
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Dermal Torque Meter
Observational Measure for documentation of scar characteristics
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Scar Photography
Observational Measure for documentation of scar characteristics
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Prosthesis Limb User Survey - Mobility
Patient reported outcome measure with scores from 20-80 with increase in score demonstrating increase in self reported functional mobility
Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Contact the study team to confirm eligibility.
February 1, 2024
Primary Completion
January 31, 2026
Actual (reported)Study Completion
January 31, 2026
Actual (reported)Last Updated
April 21, 2026
Record last verified: 2026-04
There is no plan to share individual participant data beyond deidentified, group aggregated established scientific peer reviewed publication
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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