Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum (NCT05984654) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of ulcers with complete healing or 50 % area reduction
. 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
. 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).
. 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.