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

NCT05984654 | Withdrawn

• 1 other identifier: 2023H0207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyoderma Gangrenosum

Keywords

platelet rich plasma; pyoderma gangrenosum

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (5)

• Total surface area change

  Week 12 and week 16

• Patient Global Assessment (PGA) change

  Week 12 and week 16

• Investigator Global Assessment (IGA) change

  Week 12 and week 16

• Patient pain perception

  Week 12 and week 16

• Change in quality of life

  Week 12 and week 16

Study Arms (3)

Target ulcer Group 1(Injectable PRP)

EXPERIMENTAL

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.

Procedure: Platelet rich plasma therapy

Target ulcer Group 2(Topical PRP)

EXPERIMENTAL

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.

Procedure: Platelet rich plasma therapy

Target ulcer Group 3(No treatment)

NO INTERVENTION

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

Interventions

Platelet rich plasma therapy PROCEDURE

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.

Target ulcer Group 1(Injectable PRP); Target ulcer Group 2(Topical PRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Study Officials

• Benjamin H. Kaffenberger, MD

  The Ohio State University- Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Dermatology

Model Details: Parallel assignment

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: May 28, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)