xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966636</url>
    </required_header>
    <id_info>
      <org_study_id>A4110-P</org_study_id>
      <secondary_id>1I21RX004110-01A1</secondary_id>
      <nct_id>NCT05966636</nct_id>
    </id_info>
    <brief_title>LASER Pilot Project</brief_title>
    <acronym>LASER</acronym>
    <official_title>The LASER Pilot Project: Laser Therapy in Amputee Skin Care to Enhance Rehabilitation. A Preliminary InvestigationA</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Miami Dermatology and Laser Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bruce W. Carter VA Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Office of Research and Development</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Veterans who use prosthetic limbs commonly suffer from skin problems such as scars that&#xD;
        create discomfort and pain to the point that wearing the prosthesis is no longer tolerable.&#xD;
        The Veteran must then discontinue prosthetic use to allow healing prior to wearing the limb&#xD;
        again. Current treatments for skin problems include manual scar mobilization and massage,&#xD;
        stretching, desensitization techniques, pain medication, prosthetic adjustment, steroid&#xD;
        injection, scar excision and others. Most of these have not proven to be a long-term&#xD;
        solution. A dermatologic procedure common in non-amputees for scar and skin lesion&#xD;
        management, fractionated laser therapy, may be a long-term solution minimizing discomfort,&#xD;
        pain and time out of the prosthesis. This preliminary study seeks to determine if fractional&#xD;
        laser therapy can improve prosthetic use, and quality of life of Veterans with amputation who&#xD;
        use lower limb prostheses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Many Veterans with lower limb amputation who use prostheses suffer from skin related&#xD;
        prosthetic fit issues such as scars. Problematic scars may be managed with surgical excision&#xD;
        that can yield a larger, more sensitive scar. Massage and desensitization techniques are also&#xD;
        options. These current interventions yield widely varied results based on many factors&#xD;
        including clinician skill, which modality is selected, patient compliance and others.&#xD;
        Prosthetic use, walking, training, scar steroid injection and other therapies are options for&#xD;
        scar management today. Current scar management treatments are limited due to high variance in&#xD;
        effectiveness. Fractionated CO2 laser treatment however is a proven intervention for scar&#xD;
        treatment in non-amputee patients, such as those with limb salvage or burns. The overall goal&#xD;
        of this preliminary study is to determine if fractionated CO2 laser therapy, may potentially&#xD;
        improve outcomes in Veterans who use prostheses who have limitations due to problematic&#xD;
        scars.&#xD;
  &#xD;
        In this preliminary investigation, the investigators will study the potential of fractionated&#xD;
        CO2 laser therapy to decrease scar related discomfort, improve mobility and comfort otherwise&#xD;
        restricted from problematic stump scarring and thus to improve quality of life. The&#xD;
        investigators anticipate this will be a high-impact rapid translation intervention with the&#xD;
        potential to restore functionality to individuals with lower limb amputation and transform&#xD;
        the role of dermatologic care in lower limb prosthetics. The objective of this preliminary&#xD;
        study is to explore the ability to recruit a sample of lower limb prosthesis users,&#xD;
        coordinate laser therapy, collect outcomes and assure coordination and data fidelity between&#xD;
        sites and facilitate determination of parameters for a future, more definitive clinical study&#xD;
        of fractionated CO2 laser in the lower limb amputee population burdened with problematic&#xD;
        scarring. The investigators' clinical hypothesis is fractionated CO2 laser treatment will&#xD;
        provide considerable improvements in comfort, pain reduction, mobility and quality of life in&#xD;
        lower limb prosthesis users. Further, it's hypothesize the investigators will be able to&#xD;
        recruit a sample, assure data fidelity and be able to use the outcomes to estimate the power&#xD;
        and sample to support a future clinical investigation and VA Merit application.&#xD;
  &#xD;
        Six to eight subjects will be recruited from the Tampa VA. They will receive a pre-procedural&#xD;
        assessment including subjective and objective measures ultimately to measure functional&#xD;
        mobility, socket comfort, prosthetic history, health related quality of life and residual&#xD;
        limb measures (i.e. volumetrics, range of motion, muscle testing and others). Subjects will&#xD;
        then be evaluated (including dermatologic outcome measures) by and receive laser therapy from&#xD;
        a credentialed dermatologist and then return to the Tampa VA to repeat the aforementioned&#xD;
        outcomes at 6 week, 3 months and 6 months follow ups. Following laser therapy, outcomes data&#xD;
        will be analyzed to determine the treatment effect, power and ultimately, the necessary&#xD;
        sample size for a future VA Merit proposal. Additionally, the study will provide preliminary&#xD;
        evidence of efficacy of laser therapy in this population. It will also permit selection of&#xD;
        the most ideal outcome measures and facilitate optimization of a protocol for the&#xD;
        configuration of an optimized, more definitive study to determine efficacy of laser therapy&#xD;
        in Veterans with lower limb amputation who use prostheses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 11, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Study statistician will be masked</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Prosthesis Evaluation Questionnaire</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Patient Reported Outcome Measure with score from 0-100 with increased score demonstrated patient reported improvement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in 2 minute walk test</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Functional performance with score from 0 - 999 feet with increased score demonstrating increased velocity in walking</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in The Patient and Observer Scar Assessment Scale</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Dermatologic Survey on a scale of 1-10 with increased number demonstrating worsening of scar appearance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Optical Coherence Tomography</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Observational Measure for documentation of scar characteristics</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Manchester Scar Scale</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Dermatologic survey on a scale of 1-4 with higher numbers representing worsening of conditions of scar</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Dermatology Life Quality Index</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Dermal Torque Meter</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Observational Measure for documentation of scar characteristics</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Scar Photography</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Observational Measure for documentation of scar characteristics</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Prosthesis Limb User Survey - Mobility</measure>
      <time_frame>Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits</time_frame>
      <description>Patient reported outcome measure with scores from 20-80 with increase in score demonstrating increase in self reported functional mobility</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Acquired Absence of Lower Limb</condition>
    <condition>Scar Condition and Fibrosis of the Skin</condition>
    <arm_group>
      <arm_group_label>Observational Single Arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All subjects will have scars, quality of life, function assessed pre and post laser treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Fractional CO2 Laser Ablative Resurfacing</intervention_name>
      <description>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.</description>
      <arm_group_label>Observational Single Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 21-70 years.&#xD;
  &#xD;
            -  Lower extremity amputation at the transtibial or transfemoral levels.&#xD;
  &#xD;
            -  Lower extremity amputee who has regular and compliant use of a lower extremity&#xD;
               prosthesis.&#xD;
  &#xD;
            -  Lower extremity prosthesis use is disrupted or complicated by scarring and other skin&#xD;
               maladies treatable with fractional CO2 laser therapy.&#xD;
  &#xD;
            -  Cognitive ability to understand and willingness to provide informed consent and follow&#xD;
               the study protocol.&#xD;
  &#xD;
            -  Willing and able to attend pre and post procedural assessment sessions.&#xD;
  &#xD;
            -  Willing and able to attend dermatologic and laser therapy sessions.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Does not have lower extremity amputation.&#xD;
  &#xD;
            -  Lower extremity amputee who does not use a prosthesis.&#xD;
  &#xD;
            -  Lower extremity prosthetic use is not disrupted due to scarring or other skin&#xD;
               maladies.&#xD;
  &#xD;
            -  Residual limb has an open wound or active infection.&#xD;
  &#xD;
            -  Has any of the following; open residual limb wound, cultured epithelial autographts,&#xD;
               active infection, presence of unstable epithelium within the early weeks of injury&#xD;
  &#xD;
            -  Otherwise not a candidate for laser therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jeffrey T Heckman, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>James A. Haley Veterans' Hospital, Tampa, FL</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anita Ramrattan, DPT MS</last_name>
      <phone>(813) 558-3997</phone>
      <email>anita.ramrattan@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeffrey T Heckman, DO</last_name>
      <phone>(813) 972-2000</phone>
      <phone_ext>7506</phone_ext>
      <email>Jeffrey.T.Heckman@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Miami VA Healthcare System, Miami, FL</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33125</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ignacio Gaunaurd, PhD</last_name>
        <phone>305-206-2441</phone>
        <email>ignacio.gaunaurd@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Luis Gonzalez, MBA</last_name>
        <phone>7867608959</phone>
        <email>Luis.Gonzalez2@va.gov</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>James A. Haley Veterans' Hospital, Tampa, FL</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33612</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Briana N Chilton</last_name>
        <phone>813-558-7610</phone>
        <email>Briana.Chilton@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Margaret R Covar</last_name>
        <phone>(813) 903-4407</phone>
        <email>Margaret.Covar@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Jeffrey T Heckman, DO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Amputation</keyword>
    <keyword>Scar</keyword>
    <keyword>Fractional Ablative Laser Resurfacing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to share individual participant data beyond deidentified, group aggregated established scientific peer reviewed publication</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966636
  org study id: A4110-P
  secondary id: 1I21RX004110-01A1
  nct id: NCT05966636
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention 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.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Study statistician will be masked
  measure: Change in Prosthesis Evaluation Questionnaire
  time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
  description: Patient Reported Outcome Measure with score from 0-100 with increased score demonstrated patient reported improvement
  measure: Change in 2 minute walk test
  time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
  description: Functional performance with score from 0 - 999 feet with increased score demonstrating increased velocity in walking
  measure: 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
  description: Dermatologic Survey on a scale of 1-10 with increased number demonstrating worsening of scar appearance
  measure: Change in Optical Coherence Tomography
  time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
  description: Observational Measure for documentation of scar characteristics
  measure: Change in Manchester Scar Scale
  time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
  description: Dermatologic survey on a scale of 1-4 with higher numbers representing worsening of conditions of scar
  measure: Change in Dermatology Life Quality Index
  time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
  description: 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
  measure: Change in Dermal Torque Meter
  time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
  description: Observational Measure for documentation of scar characteristics
  measure: Change in Scar Photography
  time frame: Baseline and post Treatment LASER Visit (week 6), and 3 and 6 month follow up visits
  description: Observational Measure for documentation of scar characteristics
  measure: 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
  description: Patient reported outcome measure with scores from 20-80 with increase in score demonstrating increase in self reported functional mobility
  arm group label: Observational Single Arm
  arm group type: Other
  description: All subjects will have scars, quality of life, function assessed pre and post laser treatment
  intervention type: Procedure
  intervention name: Fractional CO2 Laser Ablative Resurfacing
  description: 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.
  arm group label: Observational Single Arm
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeffrey T Heckman, DO
  role: Principal Investigator
  affiliation: James A. Haley Veterans' Hospital, Tampa, FL
  last name: Anita Ramrattan, DPT MS
  phone: (813) 558-3997
  email: anita.ramrattan@va.gov
  last name: Jeffrey T Heckman, DO
  phone: (813) 972-2000
  phone ext: 7506
  email: Jeffrey.T.Heckman@va.gov
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Fibrosis
  sharing ipd: No
  ipd description: There is no plan to share individual participant data beyond deidentified, group aggregated established scientific peer reviewed publication