Acquired Absence of Lower LimbLASERNCT05966636
LASER Pilot Project
A study testing Fractional CO2 Laser Ablative Resurfacing in people with Acquired Absence of Lower Limb and Scar Condition and Fibrosis of the Skin, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Absence of Lower Limb, Scar Condition and Fibrosis of the Skin
- What is being tested?
- Fractional CO2 Laser Ablative Resurfacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary Investigation
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.
Read 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 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, the investigators 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. The investigators 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. The investigators' 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, it's hypothesize the investigators 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.
- Being tested
- Fractional CO2 Laser Ablative Resurfacing
- Keywords
- Amputation, Scar, Fractional Ablative Laser Resurfacing
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 Laser Ablative ResurfacingProcedure or surgery
Fractional lasers stimulate scar improvement through production of microscopic patterns of dermal injury, vaporizing scar tissue and inducing neocollagenesis, subsequently improving scar tissue texture and range of motion, and decreasing symptoms such as pain and pruritis. Current clinical consensus is supportive that fractionated lasers are the most effective option for the treatment of scars. Other laser wavelengths and modalities used for vascular deformities and hair removal for instance, have an adjunctive role in improving scars and may be used in the same laser session. Case reports provide evidence of substantial improvement in sensory symptoms and physical mobility within days to weeks after each treatment.
| Study group | Role | What they receive |
|---|---|---|
| Observational Single Arm | Other | All subjects will have scars, quality of life, function assessed pre and post laser treatment Receives: Procedure: Fractional CO2 Laser Ablative Resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prosthesis Evaluation Questionnaire
Patient Reported Outcome Measure with score from 0-100 with increased score demonstrated patient reported improvement
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in 2 minute walk test
Functional performance with score from 0 - 999 feet with increased score demonstrating increased velocity in walking
Measured: 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
Dermatologic Survey on a scale of 1-10 with increased number demonstrating worsening of scar appearance
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Optical Coherence Tomography
Observational Measure for documentation of scar characteristics
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Manchester Scar Scale
Dermatologic survey on a scale of 1-4 with higher numbers representing worsening of conditions of scar
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Dermatology Life Quality Index
Dermatologic survey using a scale from scar problems resulting in very much, a lot, a little or not at all impacts to quality of life
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Dermal Torque Meter
Observational Measure for documentation of scar characteristics
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Scar Photography
Observational Measure for documentation of scar characteristics
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Change in Prosthesis Limb User Survey - Mobility
Patient reported outcome measure with scores from 20-80 with increase in score demonstrating increase in self reported functional mobility
Measured: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Feb 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Absence of Lower LimbStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will perform pre and post assessment of laser treatment techniques to improve scar mobility and skin health in a pilot sample of individuals with lower extremity limb loss who use artificial limbs for mobility.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Miami Dermatology and Laser Institute, Bruce W. Carter VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Jeffrey T Heckman, DO, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966636
- Sponsor's protocol ID
- A4110-P
- Other IDs
- 1I21RX004110-01A1
- Acronym
- LASER
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data beyond deidentified, group aggregated established scientific peer reviewed publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary Investigation
- ClinicalTrials.gov ID
- NCT05966636
- Acronym / sponsor ID
- LASER / A4110-P
- Keywords
- Amputation, Scar, Fractional Ablative Laser Resurfacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Miami Dermatology and Laser Institute, Bruce W. Carter VA Medical Center
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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, the investigators 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. The investigators 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. The investigators' 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, it's hypothesize the investigators 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will perform pre and post assessment of laser treatment techniques to improve scar mobility and skin health in a pilot sample of individuals with lower extremity limb loss who use artificial limbs for mobility.
| Arm | Type | Receives |
|---|---|---|
| Observational Single Arm | Other | Procedure: Fractional CO2 Laser Ablative ResurfacingAll subjects will have scars, quality of life, function assessed pre and post laser treatment |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional CO2 Laser Ablative ResurfacingFractional lasers stimulate scar improvement through production of microscopic patterns of dermal injury, vaporizing scar tissue and inducing neocollagenesis, subsequently improving scar tissue texture and range of motion, and decreasing symptoms such as pain and pruritis. Current clinical consensus is supportive that fractionated lasers are the most effective option for the treatment of scars. Other laser wavelengths and modalities used for vascular deformities and hair removal for instance, have an adjunctive role in improving scars and may be used in the same laser session. Case reports provide evidence of substantial improvement in sensory symptoms and physical mobility within days to weeks after each treatment. | Procedure or surgery | Observational Single Arm |
Primary outcome
Change in Prosthesis Evaluation Questionnaire
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Patient Reported Outcome Measure with score from 0-100 with increased score demonstrated patient reported improvement
Change in 2 minute walk test
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Functional performance with score from 0 - 999 feet with increased score demonstrating increased velocity in walking
Change in The Patient and Observer Scar Assessment Scale
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Dermatologic Survey on a scale of 1-10 with increased number demonstrating worsening of scar appearance
Change in Optical Coherence Tomography
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Observational Measure for documentation of scar characteristics
Change in Manchester Scar Scale
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Dermatologic survey on a scale of 1-4 with higher numbers representing worsening of conditions of scar
Change in Dermatology Life Quality Index
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Dermatologic survey using a scale from scar problems resulting in very much, a lot, a little or not at all impacts to quality of life
Change in Dermal Torque Meter
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Observational Measure for documentation of scar characteristics
Change in Scar Photography
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Observational Measure for documentation of scar characteristics
Change in Prosthesis Limb User Survey - Mobility
Time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
Patient reported outcome measure with scores from 20-80 with increase in score demonstrating increase in self reported functional mobility
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data beyond deidentified, group aggregated established scientific peer reviewed publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey T Heckman, DO principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO2 Laser Ablative Resurfacing in people with Acquired Absence of Lower Limb and Scar Condition and Fibrosis of the Skin, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prosthesis Evaluation Questionnaire (time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.