Status:
RECRUITING
LASER Pilot Project
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Miami Dermatology and Laser Institute
Bruce W. Carter VA Medical Center
Conditions:
Acquired Absence of Lower Limb
Scar Condition and Fibrosis of the Skin
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief 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 the...
Detailed Description
Many Veterans with lower limb amputation who use prostheses suffer from skin related prosthetic fit issues such as scars. Problematic scars may be managed with surgical excision that can yield a large...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05966636
Start Date
February 1 2024
End Date
January 31 2026
Last Update
January 27 2025
Active Locations (2)
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1
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
2
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612