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Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum

Primary Purpose

Pyoderma Gangrenosum

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet rich plasma therapy
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyoderma Gangrenosum focused on measuring platelet rich plasma, pyoderma gangrenosum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have given written informed consent before participating in any study-specific activity. Have a clinical diagnosis of classic PG as determined by the principal investigator based on results from clinical, histological, and laboratory assessments. Have at least 2 PG ulcer characterized by 'item a' AND 3/5 features in 'item b' OR 2/5 features in 'item b' with support from one of the conditions listed in c. a. Stable or increasing size within 2 months preceding screening by patient report or documentation. b. Features such as violaceous border, undermining, cribriform scarring, pustules, peristomal location. c. Identifiable secondary systemic condition, such as IBD, arthritis, MGUS, noncancerous hematologic disease, streptococcal carriage, levamisole-tainted cocaine, Bruton's agammaglobulinemia. Have at least two PG target ulcers that have an area = 2 cm2 and = 200 cm2 at screening. Age at least 18 years at screening. A negative pregnancy test (for females of childbearing potential) at both screening and at Day 0. PARACELSUS Score for pyoderma gangrenosum of 10 or greater. Exclusion Criteria: Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may jeopardize the subject's safety after treatment, may confound the study results, or may interfere significantly with the subject's participation in the study. History of malignancy within 2 years of screening other than carcinoma in situ of the cervix or adequately treated, non-metastatic, squamous, or basal cell carcinoma of the skin. History of seropositivity for HIV antibody; active or carrier status of hepatitis B [surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with negative surface antibody]; active hepatitis C (i.e., not treated or not cleared spontaneously, as confirmed by HCV PCR). Patients with hemodynamic instability, bleeding disorders, and/or platelet dysfunction syndrome. A complete blood count will be performed for each participant at the beginning of the study and those with serum hemoglobin concentration <11 g/ dL or hematocrit <34% or platelet count<1, 00000/ml will be excluded from the study. Patients with uncontrolled secondary systemic disease in the opinion of the investigator. Systemic infection or active local infection requiring oral antibiotics within 2 weeks of Day 0. History of the following treatments: Patients taking anticoagulant medication. Changes (addition, discontinuation, or changes in dose) in immunosuppressive medication (including cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, apremilast, dapsone, or corticosteroids) and biologics (Anti-TNF or other biologic therapies) within 2 months of Day 0. Systemic corticosteroids > 20 mg per day (prednisone or prednisone equivalent) within 8 weeks of Day 0 or change in dose within 4 weeks of Day 0. Steroids may be tapered (although not increased above the Day 0 dose) during the trial as determined by the principal investigator. Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulators are also not permitted. Systemic antibiotics within 2 weeks of Day 0. Hyperbaric treatment within 4 weeks of Day 0. Investigational drug or investigational device within 4 weeks of Day 0. Other treatments not described above should be maintained at a stable dose and frequency throughout the study as best as possible. Major, general surgery within 3 months of screening, or anticipated general surgery during the study period. Pregnancy plans to become pregnant during the study, delivery within 3 months of screening, or breastfeeding. If previous use of cyclosporine or systemic corticosteroids, failure to have any stabilization/response is exclusionary. This potentially indicates the disease is not PG.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Target ulcer Group 1(Injectable PRP)

    Target ulcer Group 2(Topical PRP)

    Target ulcer Group 3(No treatment)

    Arm 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.

    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.

    Target ulcer in the control group will receive standard wound care only.

    Outcomes

    Primary Outcome Measures

    Proportion of ulcers with complete healing or 50 % area reduction
    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

    Secondary Outcome Measures

    Total surface area change
    Analysis of change in total surface area of target/total ulcers from baseline to week 12 and week 16
    Patient Global Assessment (PGA) change
    Analysis of change Patient Global Assessment (PGA) from baseline until baseline to week 12 and week 16
    Investigator Global Assessment (IGA) change
    Analysis of change Investigator Global Assessment (IGA) x maximum wound dimension from baseline until baseline to week 12 and week 16
    Patient pain perception
    Analysis of change in patient pain perception using 10-point visual analog scale (VAS) from baseline to week 12 and week 16. This is a 10 point scale with higher scores indicating more severe pain.
    Change in quality of life
    Analysis of change in patient quality of life using the dermatology life quality index (DLQI) from baseline to week 12 and week 16.

    Full Information

    First Posted
    August 2, 2023
    Last Updated
    October 22, 2023
    Sponsor
    Ohio State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05984654
    Brief Title
    Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 28, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pyoderma Gangrenosum
    Keywords
    platelet rich plasma, pyoderma gangrenosum

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Target ulcer Group 1(Injectable PRP)
    Arm Type
    Experimental
    Arm 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 Title
    Target ulcer Group 2(Topical PRP)
    Arm Type
    Experimental
    Arm 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 Title
    Target ulcer Group 3(No treatment)
    Arm Type
    No Intervention
    Arm Description
    Target ulcer in the control group will receive standard wound care only.
    Intervention Type
    Procedure
    Intervention Name(s)
    Platelet rich plasma therapy
    Intervention 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. Note this is not a device or a medicine as this is autologous plasma.
    Primary Outcome Measure Information:
    Title
    Proportion of ulcers with complete healing or 50 % area reduction
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Total surface area change
    Description
    Analysis of change in total surface area of target/total ulcers from baseline to week 12 and week 16
    Time Frame
    Week 12 and week 16
    Title
    Patient Global Assessment (PGA) change
    Description
    Analysis of change Patient Global Assessment (PGA) from baseline until baseline to week 12 and week 16
    Time Frame
    Week 12 and week 16
    Title
    Investigator Global Assessment (IGA) change
    Description
    Analysis of change Investigator Global Assessment (IGA) x maximum wound dimension from baseline until baseline to week 12 and week 16
    Time Frame
    Week 12 and week 16
    Title
    Patient pain perception
    Description
    Analysis of change in patient pain perception using 10-point visual analog scale (VAS) from baseline to week 12 and week 16. This is a 10 point scale with higher scores indicating more severe pain.
    Time Frame
    Week 12 and week 16
    Title
    Change in quality of life
    Description
    Analysis of change in patient quality of life using the dermatology life quality index (DLQI) from baseline to week 12 and week 16.
    Time Frame
    Week 12 and week 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have given written informed consent before participating in any study-specific activity. Have a clinical diagnosis of classic PG as determined by the principal investigator based on results from clinical, histological, and laboratory assessments. Have at least 2 PG ulcer characterized by 'item a' AND 3/5 features in 'item b' OR 2/5 features in 'item b' with support from one of the conditions listed in c. a. Stable or increasing size within 2 months preceding screening by patient report or documentation. b. Features such as violaceous border, undermining, cribriform scarring, pustules, peristomal location. c. Identifiable secondary systemic condition, such as IBD, arthritis, MGUS, noncancerous hematologic disease, streptococcal carriage, levamisole-tainted cocaine, Bruton's agammaglobulinemia. Have at least two PG target ulcers that have an area = 2 cm2 and = 200 cm2 at screening. Age at least 18 years at screening. A negative pregnancy test (for females of childbearing potential) at both screening and at Day 0. PARACELSUS Score for pyoderma gangrenosum of 10 or greater. Exclusion Criteria: Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may jeopardize the subject's safety after treatment, may confound the study results, or may interfere significantly with the subject's participation in the study. History of malignancy within 2 years of screening other than carcinoma in situ of the cervix or adequately treated, non-metastatic, squamous, or basal cell carcinoma of the skin. History of seropositivity for HIV antibody; active or carrier status of hepatitis B [surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with negative surface antibody]; active hepatitis C (i.e., not treated or not cleared spontaneously, as confirmed by HCV PCR). Patients with hemodynamic instability, bleeding disorders, and/or platelet dysfunction syndrome. A complete blood count will be performed for each participant at the beginning of the study and those with serum hemoglobin concentration <11 g/ dL or hematocrit <34% or platelet count<1, 00000/ml will be excluded from the study. Patients with uncontrolled secondary systemic disease in the opinion of the investigator. Systemic infection or active local infection requiring oral antibiotics within 2 weeks of Day 0. History of the following treatments: Patients taking anticoagulant medication. Changes (addition, discontinuation, or changes in dose) in immunosuppressive medication (including cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, apremilast, dapsone, or corticosteroids) and biologics (Anti-TNF or other biologic therapies) within 2 months of Day 0. Systemic corticosteroids > 20 mg per day (prednisone or prednisone equivalent) within 8 weeks of Day 0 or change in dose within 4 weeks of Day 0. Steroids may be tapered (although not increased above the Day 0 dose) during the trial as determined by the principal investigator. Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulators are also not permitted. Systemic antibiotics within 2 weeks of Day 0. Hyperbaric treatment within 4 weeks of Day 0. Investigational drug or investigational device within 4 weeks of Day 0. Other treatments not described above should be maintained at a stable dose and frequency throughout the study as best as possible. Major, general surgery within 3 months of screening, or anticipated general surgery during the study period. Pregnancy plans to become pregnant during the study, delivery within 3 months of screening, or breastfeeding. If previous use of cyclosporine or systemic corticosteroids, failure to have any stabilization/response is exclusionary. This potentially indicates the disease is not PG.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin H. Kaffenberger, MD
    Phone
    (614) 2931707
    Email
    Benjamin.Kaffenberger@osumc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Manjit Kaur, MBBS
    Email
    Manjit.Kaur@osumc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Benjamin H. Kaffenberger, MD
    Organizational Affiliation
    The Ohio State University- Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum

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