ClinicalTrials.gg
WithdrawnNCT05984654Updated Aug 11, 2025

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

An interventional study of Platelet rich plasma therapy in Pyoderma Gangrenosum, sponsored by Ohio State University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Did not obtain funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pyoderma Gangrenosum

Browse trials for

Keywords

  • platelet rich plasma
  • pyoderma gangrenosum
03

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Have given written before participating in any study-specific activity.
  2. Have a clinical diagnosis of classic PG as determined by the principal investigator based on results from clinical, histological, and laboratory assessments.
  3. 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.
  4. Have at least two PG target ulcers that have an area = 2 cm2 and = 200 cm2 at screening.
  5. Age at least 18 years at screening.
  6. A negative pregnancy test (for females of ) at both screening and at Day 0.
  7. PARACELSUS Score for pyoderma gangrenosum of 10 or greater.

Exclusion criteria

Exclusion Criteria:

  1. Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written , 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.
  2. History of within 2 years of screening other than carcinoma in situ of the cervix or adequately treated, non-, squamous, or basal cell carcinoma of the skin.
  3. History of seropositivity for antibody; active or carrier status of [surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with negative surface antibody]; active (i.e., not treated or not cleared spontaneously, as confirmed by HCV PCR).
  4. Patients with hemodynamic instability, bleeding disorders, and/or dysfunction syndrome.
  5. A complete blood count will be performed for each participant at the beginning of the study and those with serum concentration \<11 g/ dL or hematocrit \<34% or platelet count\<1, 00000/ml will be excluded from the study.
  6. Patients with uncontrolled secondary systemic disease in the opinion of the investigator.
  7. Systemic infection or active local infection requiring oral antibiotics within 2 weeks of Day 0.
  8. History of the following treatments:

    1. Patients taking anticoagulant medication.
    2. Changes (addition, discontinuation, or changes in dose) in medication (including cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, apremilast, dapsone, or ) and biologics (Anti-TNF or other biologic therapies) within 2 months of Day 0.
    3. 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.
    4. Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulators are also not permitted.
    5. Systemic antibiotics within 2 weeks of Day 0.
    6. Hyperbaric treatment within 4 weeks of Day 0.
    7. drug or investigational device within 4 weeks of Day 0.
    8. Other treatments not described above should be maintained at a stable dose and frequency throughout the study as best as possible.
  9. Major, general surgery within 3 months of screening, or anticipated general surgery during the study period.
  10. Pregnancy plans to become pregnant during the study, delivery within 3 months of screening, or breastfeeding.
  11. If previous use of cyclosporine or systemic corticosteroids, failure to have any stabilization/response is exclusionary. This potentially indicates the disease is not PG.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Target ulcer Group 1(Injectable PRP)

    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

  • Experimental
    Target ulcer Group 2(Topical PRP)

    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

  • No intervention
    Target ulcer Group 3(No treatment)

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

Interventions

  • ProcedurePlatelet rich plasma therapy

    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.

06

What researchers measure

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

    Time frame: 12 weeks

Secondary outcomes

  1. Total surface area change

    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

  2. Patient Global Assessment (PGA) change

    Analysis of change Patient Global Assessment (PGA) from baseline until baseline to week 12 and week 16

    Time frame: Week 12 and week 16

  3. 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

    Time frame: Week 12 and week 16

  4. 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.

    Time frame: Week 12 and week 16

  5. 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.

    Time frame: Week 12 and week 16

07

Study locations

1 site
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05984654
Responsible party
Ben H Kaffenberger (Clinical Associate Professor of Dermatology, Ohio State University) — Principal investigator
First posted
Aug 9, 2023
Start date
May 28, 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Aug 11, 2025

Study contacts

Benjamin H. Kaffenberger, MD
principal investigator · The Ohio State University- Dermatology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion