WithdrawnNot Applicable

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

Stopped: Did not obtain funding

United States0Started 2024-05-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Proportion of ulcers with complete healing or 50 % area reduction

Timeframe: 12 weeks

Trial details

NCT IDNCT05984654

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Pyoderma Gangrenosum trials