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Principal Investigator: Jeffrey T. Heckman
Organization: JAMES A. HALEY VA MEDICAL CENTER
Fiscal Year: 2024
Funding agency: Veterans Affairs
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 and ultimately, the necessary
sample size for a future VA Merit proposal. Additionally, the study will provide preliminary
evidence of efficacy of laser therapy in this population. It will also permit selection of the most
ideal outcome measures and facilitate optimization of a protocol for the configuration of an
optimized, more definitive study to determine efficacy of laser therapy in Veterans with lower
limb amputation who use prostheses.
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