The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary Investigation

NIH RePORTER · VA · I21 · · view on reporter.nih.gov ↗

Abstract

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 larger, more sensitive scar. Massage and desensitization techniques are also options. These current interventions yield widely varied results based on many factors including clinician skill, which modality is selected, patient compliance and others. Prosthetic use, walking, training, scar steroid injection and other therapies are options for scar management today. Current scar management treatments are limited due to high variance in effectiveness. Fractionated CO2 laser treatment however is a proven intervention for scar treatment in non- amputee patients, such as those with limb salvage or burns. The overall goal of this preliminary study is to determine if fractionated CO2 laser therapy, may potentially improve outcomes in Veterans who use prostheses who have limitations due to problematic scars. In this preliminary investigation, we will study the potential of fractionated CO2 laser therapy to decrease scar related discomfort, improve mobility and comfort otherwise restricted from problematic stump scarring and thus to improve quality of life. We anticipate this will be a high- impact rapid translation intervention with the potential to restore functionality to individuals with lower limb amputation and transform the role of dermatologic care in lower limb prosthetics. The objective of this preliminary study is to explore the ability to recruit a sample of lower limb prosthesis users, coordinate laser therapy, collect outcomes and assure coordination and data fidelity between sites and facilitate determination of parameters for a future, more definitive clinical study of fractionated CO2 laser in the lower limb amputee population burdened with problematic scarring. Our clinical hypothesis is fractionated CO2 laser treatment will provide considerable improvements in comfort, pain reduction, mobility and quality of life in lower limb prosthesis users. Further, we hypothesize we will be able to recruit a sample, assure data fidelity and be able to use the outcomes to estimate the power and sample to support a future clinical investigation and VA Merit application. Six to eight subjects will be recruited from the Tampa VA. They will receive a pre-procedural assessment including subjective and objective measures ultimately to measure functional mobility, socket comfort, prosthetic history, health related quality of life and residual limb measures (i.e. volumetrics, range of motion, muscle testing and others). Subjects will then be evaluated (including dermatologic outcome measures) by and receive laser therapy from a credentialed dermatologist and then return to the Tampa VA to repeat the aforementioned outcomes at 6 week, 3 months and 6 months follow ups. Following laser therapy, outcomes data will be analyzed to determine the treatment effect, power an...

Key facts

NIH application ID
10701994
Project number
1I21RX004110-01A1
Recipient
JAMES A. HALEY VA MEDICAL CENTER
Principal Investigator
Jeffrey T. Heckman
Activity code
I21
Funding institute
VA
Fiscal year
2024
Award amount
Award type
1
Project period
2024-02-01 → 2026-01-31