Using laser therapy to improve skin issues in veterans with lower limb amputations
The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary InvestigationA
This study is testing if laser therapy can help veterans with lower limb amputations improve their skin issues and feel more comfortable using their prosthetic limbs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT05966636 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of fractional CO2 laser therapy in treating problematic scars and skin conditions in veterans who use lower limb prostheses. Many veterans experience discomfort and pain due to scarring, which can hinder their ability to wear prosthetic limbs. The study aims to assess whether this dermatologic procedure can enhance mobility, reduce discomfort, and improve the overall quality of life for these individuals. Participants will undergo laser therapy and be evaluated for improvements in their condition and prosthetic use.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 21-70 with lower extremity amputations who regularly use prostheses but experience complications due to scarring.
Not a fit: Patients who do not have lower extremity amputations or whose prosthetic use is not affected by scarring may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for veterans by allowing them to use their prostheses more comfortably and effectively.
How similar studies have performed: Previous studies have shown success with fractional CO2 laser therapy in non-amputee patients, suggesting potential for similar benefits in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Miami, Florida and 1 other locations
- Miami VA Healthcare System, Miami, FL — Miami, Florida, United States (Recruiting)
- James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey T Heckman, DO — James A. Haley Veterans' Hospital, Tampa, FL
- Study coordinator: Meghan E Kern, DPT
- Email: meghan.kern@va.gov
- Phone: (813) 585-1802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.