NCT05984654

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

A Prospective, Open-label, Randomized, Split-ulcer Trial to Evaluate the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Chronic Pyoderma Gangrenosum.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pyoderma Gangrenosum

Interventions

Type	Name	Description
PROCEDURE	Platelet 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.

Timeline

• Start date: 2024-05-28
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-08-09
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States