# Diagnostic and treatment landscape of pyoderma gangrenosum

> **NIH NIH R01** · OREGON HEALTH & SCIENCE UNIVERSITY · 2024 · $207,075

## Abstract

Pyoderma gangrenosum (PG) is a rare, chronic, inflammatory disorder that presents with painful skin ulcers. It
causes disfiguration, negatively impacts quality of life, and increases mortality. Despite being a disease with
significant physical and psychological impact, it remains understudied. The paucity of clinical research in the
field is likely due to challenges in diagnosis and unknown treatment outcomes. Misdiagnosis, which is reported
in up to 39% of patients, has been one of the main obstacles to proper implementation and enrollment in clinical
trials. Because molecular diagnostics remain years away, researchers rely on clinical criteria for diagnosis. Three
diagnostic frameworks exist based on clinical findings, however they are not widely applied or accepted.
Moreover, the mainstay of treatment for PG is immunosuppression. Monotherapy with systemic corticosteroids
or cyclosporine is the classical initial treatment, and only a few clinical trials have evaluated the effectiveness
and safety of new therapeutic alternatives such as biologics. Further, combination or concomitant therapy of
classic immunosuppression and biologics has been adopted as a new standard of care without high-quality data.
Current therapeutic approaches are based on expert opinion guidelines creating additional difficulty in
implementing clinical trials and hampering the FDA approval process of potential drugs.
Our proposal aligns with the overall long-term goals of our research group: to drive diagnostic and therapeutic
innovation in the field of PG – a significantly understudied disease with an increased healthcare burden. Our
short-term goals include: 1) to establish which diagnostic framework best performs in a multi-institutional
collaborative study, supporting its applicability in medical practice and clinical trials, and 2) to analyze current
treatment outcomes in clinical practice. We seek to accomplish our short-term goals utilizing the following specific
aims: Aim 1) compare and assess the three diagnostic frameworks in a multi-center prospective study of a well-
defined cohort of patients diagnosed with PG and PG-like conditions to determine their performance in diagnosis,
and Aim 2) determine the effectiveness of real-world therapeutic approaches currently used as standard of care
in a multi-center cohort of patients with PG.
Our established PG research team at OHSU has the ability to implement a multi-institutional collaborative effort
to ensure the success of this proposal. Collectively, the results of this project will fill the diagnostic and therapeutic
gaps in knowledge and define the current landscape of PG in the United States.

## Key facts

- **NIH application ID:** 10898068
- **Project number:** 5R01AR083110-02
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** Alex Ortega Loayza
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $207,075
- **Award type:** 5
- **Project period:** 2023-08-02 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10898068

## Citation

> US National Institutes of Health, RePORTER application 10898068, Diagnostic and treatment landscape of pyoderma gangrenosum (5R01AR083110-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10898068. Licensed CC0.

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