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/NCT05984654</url>
    </required_header>
    <id_info>
      <org_study_id>2023H0207</org_study_id>
      <nct_id>NCT05984654</nct_id>
    </id_info>
    <brief_title>Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum</brief_title>
    <official_title>A Prospective, Open-label, Randomized, Split-ulcer Trial to Evaluate the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Chronic Pyoderma Gangrenosum.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Pyoderma gangrenosum (PG) is a chronic inflammatory condition with severe painful ulcers. We&#xD;
        hypothesize that Platelet-rich plasma(PRP) therapy derived from patient's own blood has a&#xD;
        high concentration of endogenous growth factors, which will activate the wound-healing&#xD;
        cascade stimulating formation of new blood vessels and collagen in PG ulcers.The goal of this&#xD;
        study is to evaluate the efficacy and safety of autologous Platelet rich Plasma(PRP) therapy&#xD;
        for the treatment of chronic Pyoderma Gangrenosum(PG). Researchers will also compare the&#xD;
        efficacy of PRP therapy when used as a topical solution versus injections in and around the&#xD;
        target ulcer/s.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, randomized split-ulcer controlled trial that will enroll 10 adult&#xD;
        patients with chronic pyoderma gangrenosum. In each participant, up to three separate&#xD;
        ulcerations will be randomized into 3 comparative groups in 1:1:1 ratio to either receive&#xD;
        monthly intralesional PRP injections or topical PRP therapy at 0, 4, 8, and 12 weeks while&#xD;
        the third target ulcer will receive standard wound care only. In the event that only two&#xD;
        ulcerations are present, they will be randomized to 1:1 standard care vs topical and&#xD;
        intralesional PRP. All other ulcers, if any, will receive standard wound care during the&#xD;
        study period. Participants will be followed up for 4 weeks after the completion of treatment&#xD;
        period. The primary endpoint for this study will be the composite proportion of the target&#xD;
        ulcers achieving either complete resolution or 50% reduction in the surface area at week 12.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of ulcers with complete healing or 50 % area reduction</measure>
      <time_frame>12 weeks</time_frame>
      <description>Primary outcome will be the composite proportion of the target ulcers achieving either complete resolution or 50% reduction in the surface area at week 12 after treatment with either intralesional injectable or topical platelet-rich plasma therapy as compared to standard treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frequency of total closure</measure>
      <time_frame>Week 12 and week16</time_frame>
      <description>Analysis of the frequency of total closure of target/total ulcers from baseline to week 12 and week 16</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total surface area change</measure>
      <time_frame>Week 12 and week 16</time_frame>
      <description>Analysis of change in total surface area of target/total ulcers from baseline to week 12 and week 16</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Assessment (PGA) change</measure>
      <time_frame>Week 12 and week 16</time_frame>
      <description>Analysis of change Patient Global Assessment (PGA) from baseline until baseline to week 12 and week 16</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Investigator Global Assessment (IGA) change</measure>
      <time_frame>Week 12 and week 16</time_frame>
      <description>Analysis of change Investigator Global Assessment (IGA) x maximum wound dimension from baseline until baseline to week 12 and week 16</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient pain perception</measure>
      <time_frame>Week 12 and week 16</time_frame>
      <description>Analysis of change in patient pain perception using 10-point visual analog scale (VAS) from baseline to week 12 and week 16</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>Week 12 and week 16</time_frame>
      <description>Analysis of change in patient quality of life using the dermatology life quality index (DLQI) from baseline to week 12 and week 16.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Pyoderma Gangrenosum</condition>
    <arm_group>
      <arm_group_label>Target ulcer Group 1(Injectable PRP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Under aseptic conditions, 2 mL of autologous PRP will be injected with 30 G needle at multiple sites in and around target ulcer approximately 1.5 cm apart at 0, 4, 8, and 12 weeks after local anesthesia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Target ulcer Group 2(Topical PRP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Under aseptic conditions, 2 mL of autologous PRP will be applied topically followed by a Platelet poor plasma solution soaked dressing on the second target ulcer at 0, 4, 8, and 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Target ulcer Group 3(No treatment)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Target ulcer in the control group will receive standard wound care only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Platelet rich plasma therapy</intervention_name>
      <description>Approximately 30 ml of the patient's blood sample will be drawn from a peripheral vein in ACD (acid citrate dextrose) tubes. A double spin method will be used for the preparation of PRP.</description>
      <arm_group_label>Target ulcer Group 1(Injectable PRP)</arm_group_label>
      <arm_group_label>Target ulcer Group 2(Topical PRP)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Have given written informed consent before participating in any study-specific&#xD;
               activity.&#xD;
  &#xD;
            2. Have a clinical diagnosis of classic PG as determined by the principal investigator&#xD;
               based on results from clinical, histological, and laboratory assessments.&#xD;
  &#xD;
            3. Have at least 2 PG ulcer characterized by 'item a' AND 3/5 features in 'item b' OR 2/5&#xD;
               features in 'item b' with support from one of the conditions listed in c. a. Stable or&#xD;
               increasing size within 2 months preceding screening by patient report or&#xD;
               documentation. b. Features such as violaceous border, undermining, cribriform&#xD;
               scarring, pustules, peristomal location. c. Identifiable secondary systemic condition,&#xD;
               such as IBD, arthritis, MGUS, noncancerous hematologic disease, streptococcal&#xD;
               carriage, levamisole-tainted cocaine, Bruton's agammaglobulinemia.&#xD;
  &#xD;
            4. Have at least two PG target ulcers that have an area = 2 cm2 and = 200 cm2 at&#xD;
               screening.&#xD;
  &#xD;
            5. Age at least 18 years at screening.&#xD;
  &#xD;
            6. A negative pregnancy test (for females of childbearing potential) at both screening&#xD;
               and at Day 0.&#xD;
  &#xD;
            7. PARACELSUS Score for pyoderma gangrenosum of 10 or greater.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or&#xD;
               situation that may compromise the ability of the subject to give written informed&#xD;
               consent, may put the subject at significant risk, may jeopardize the subject's safety&#xD;
               after treatment, may confound the study results, or may interfere significantly with&#xD;
               the subject's participation in the study.&#xD;
  &#xD;
            2. History of malignancy within 2 years of screening other than carcinoma in situ of the&#xD;
               cervix or adequately treated, non-metastatic, squamous, or basal cell carcinoma of the&#xD;
               skin.&#xD;
  &#xD;
            3. History of seropositivity for HIV antibody; active or carrier status of hepatitis B&#xD;
               [surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with negative&#xD;
               surface antibody]; active hepatitis C (i.e., not treated or not cleared spontaneously,&#xD;
               as confirmed by HCV PCR).&#xD;
  &#xD;
            4. Patients with hemodynamic instability, bleeding disorders, and/or platelet dysfunction&#xD;
               syndrome.&#xD;
  &#xD;
            5. A complete blood count will be performed for each participant at the beginning of the&#xD;
               study and those with serum hemoglobin concentration &lt;11 g/ dL or hematocrit &lt;34% or&#xD;
               platelet count&lt;1, 00000/ml will be excluded from the study.&#xD;
  &#xD;
            6. Patients with uncontrolled secondary systemic disease in the opinion of the&#xD;
               investigator.&#xD;
  &#xD;
            7. Systemic infection or active local infection requiring oral antibiotics within 2 weeks&#xD;
               of Day 0.&#xD;
  &#xD;
            8. History of the following treatments:&#xD;
  &#xD;
                 1. Patients taking anticoagulant medication.&#xD;
  &#xD;
                 2. Changes (addition, discontinuation, or changes in dose) in immunosuppressive&#xD;
                    medication (including cyclosporine, azathioprine, methotrexate, mycophenolate&#xD;
                    mofetil, apremilast, dapsone, or corticosteroids) and biologics (Anti-TNF or&#xD;
                    other biologic therapies) within 2 months of Day 0.&#xD;
  &#xD;
                 3. Systemic corticosteroids &gt; 20 mg per day (prednisone or prednisone equivalent)&#xD;
                    within 8 weeks of Day 0 or change in dose within 4 weeks of Day 0. Steroids may&#xD;
                    be tapered (although not increased above the Day 0 dose) during the trial as&#xD;
                    determined by the principal investigator.&#xD;
  &#xD;
                 4. Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulators&#xD;
                    are also not permitted.&#xD;
  &#xD;
                 5. Systemic antibiotics within 2 weeks of Day 0.&#xD;
  &#xD;
                 6. Hyperbaric treatment within 4 weeks of Day 0.&#xD;
  &#xD;
                 7. Investigational drug or investigational device within 4 weeks of Day 0.&#xD;
  &#xD;
                 8. Other treatments not described above should be maintained at a stable dose and&#xD;
                    frequency throughout the study as best as possible.&#xD;
  &#xD;
            9. Major, general surgery within 3 months of screening, or anticipated general surgery&#xD;
               during the study period.&#xD;
  &#xD;
           10. Pregnancy plans to become pregnant during the study, delivery within 3 months of&#xD;
               screening, or breastfeeding.&#xD;
  &#xD;
           11. If previous use of cyclosporine or systemic corticosteroids, failure to have any&#xD;
               stabilization/response is exclusionary. This potentially indicates the disease is not&#xD;
               PG.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Benjamin H. Kaffenberger, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Ohio State University- Dermatology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Benjamin H. Kaffenberger, MD</last_name>
      <phone>(614) 2931707</phone>
      <email>Benjamin.Kaffenberger@osumc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Manjit Kaur, MBBS</last_name>
      <email>Manjit.Kaur@osumc.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University</investigator_affiliation>
      <investigator_full_name>Ben H Kaffenberger</investigator_full_name>
      <investigator_title>Clinical Associate Professor of Dermatology</investigator_title>
    </responsible_party>
    <keyword>platelet rich plasma</keyword>
    <keyword>pyoderma gangrenosum</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pyoderma</mesh_term>
      <mesh_term>Pyoderma Gangrenosum</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05984654
  org study id: 2023H0207
  nct id: NCT05984654
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pyoderma gangrenosum (PG) is a chronic inflammatory condition with severe painful ulcers. We
        hypothesize that Platelet-rich plasma(PRP) therapy derived from patient's own blood has a
        high concentration of endogenous growth factors, which will activate the wound-healing
        cascade stimulating formation of new blood vessels and collagen in PG ulcers.The goal of this
        study is to evaluate the efficacy and safety of autologous Platelet rich Plasma(PRP) therapy
        for the treatment of chronic Pyoderma Gangrenosum(PG). Researchers will also compare the
        efficacy of PRP therapy when used as a topical solution versus injections in and around the
        target ulcer/s.
  This is a prospective, randomized split-ulcer controlled trial that will enroll 10 adult
        patients with chronic pyoderma gangrenosum. In each participant, up to three separate
        ulcerations will be randomized into 3 comparative groups in 1:1:1 ratio to either receive
        monthly intralesional PRP injections or topical PRP therapy at 0, 4, 8, and 12 weeks while
        the third target ulcer will receive standard wound care only. In the event that only two
        ulcerations are present, they will be randomized to 1:1 standard care vs topical and
        intralesional PRP. All other ulcers, if any, will receive standard wound care during the
        study period. Participants will be followed up for 4 weeks after the completion of treatment
        period. The primary endpoint for this study will be the composite proportion of the target
        ulcers achieving either complete resolution or 50% reduction in the surface area at week 12.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of ulcers with complete healing or 50 % area reduction
  time frame: 12 weeks
  description: Primary outcome will be the composite proportion of the target ulcers achieving either complete resolution or 50% reduction in the surface area at week 12 after treatment with either intralesional injectable or topical platelet-rich plasma therapy as compared to standard treatment
  measure: Frequency of total closure
  time frame: Week 12 and week16
  description: Analysis of the frequency of total closure of target/total ulcers from baseline to week 12 and week 16
  measure: Total surface area change
  time frame: Week 12 and week 16
  description: Analysis of change in total surface area of target/total ulcers from baseline to week 12 and week 16
  measure: Patient Global Assessment (PGA) change
  time frame: Week 12 and week 16
  description: Analysis of change Patient Global Assessment (PGA) from baseline until baseline to week 12 and week 16
  measure: Investigator Global Assessment (IGA) change
  time frame: Week 12 and week 16
  description: Analysis of change Investigator Global Assessment (IGA) x maximum wound dimension from baseline until baseline to week 12 and week 16
  measure: Patient pain perception
  time frame: Week 12 and week 16
  description: Analysis of change in patient pain perception using 10-point visual analog scale (VAS) from baseline to week 12 and week 16
  measure: Change in quality of life
  time frame: Week 12 and week 16
  description: Analysis of change in patient quality of life using the dermatology life quality index (DLQI) from baseline to week 12 and week 16.
  arm group label: Target ulcer Group 1(Injectable PRP)
  arm group type: Experimental
  description: Under aseptic conditions, 2 mL of autologous PRP will be injected with 30 G needle at multiple sites in and around target ulcer approximately 1.5 cm apart at 0, 4, 8, and 12 weeks after local anesthesia.
  arm group label: Target ulcer Group 2(Topical PRP)
  arm group type: Experimental
  description: Under aseptic conditions, 2 mL of autologous PRP will be applied topically followed by a Platelet poor plasma solution soaked dressing on the second target ulcer at 0, 4, 8, and 12 weeks.
  arm group label: Target ulcer Group 3(No treatment)
  arm group type: No Intervention
  description: Target ulcer in the control group will receive standard wound care only.
  intervention type: Procedure
  intervention name: Platelet rich plasma therapy
  description: Approximately 30 ml of the patient's blood sample will be drawn from a peripheral vein in ACD (acid citrate dextrose) tubes. A double spin method will be used for the preparation of PRP.
  arm group label: Target ulcer Group 1(Injectable PRP)
  arm group label: Target ulcer Group 2(Topical PRP)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Benjamin H. Kaffenberger, MD
  role: Principal Investigator
  affiliation: The Ohio State University- Dermatology
  last name: Benjamin H. Kaffenberger, MD
  phone: (614) 2931707
  email: Benjamin.Kaffenberger@osumc.edu
  last name: Manjit Kaur, MBBS
  email: Manjit.Kaur@osumc.edu
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University
  investigator full name: Ben H Kaffenberger
  investigator title: Clinical Associate Professor of Dermatology
  mesh term: Pyoderma
  mesh term: Pyoderma Gangrenosum
  sharing ipd: No