CompletedNot Applicable

LASER Pilot Project

United States10 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Prosthesis Evaluation Questionnaire

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in 2 minute walk test

Timeframe: 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

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in Optical Coherence Tomography

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in Manchester Scar Scale

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in Dermatology Life Quality Index

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Trial details

NCT IDNCT05966636

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Acquired Absence of Lower Limb trials

Plain-language summary

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Prosthesis Evaluation Questionnaire

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in 2 minute walk test

Timeframe: 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

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in Optical Coherence Tomography

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in Manchester Scar Scale

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits

Change in Dermatology Life Quality Index

Timeframe: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits