Platelet-Rich Plasma Therapy for Pyoderma

Recruiting in Palo Alto (17 mi)

Overseen by Benjamin H. Kaffenberger, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Must not be taking: Anticoagulants, Immunosuppressives, Corticosteroids, others

Disqualifiers: Malignancy, HIV, Hepatitis, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you do not change your dose of immunosuppressive medications or biologics within 2 months before starting the study. Systemic corticosteroids should not exceed 20 mg per day and should not be increased during the trial. Other treatments should be kept stable throughout the study.

What data supports the effectiveness of the treatment Platelet-Rich Plasma Therapy for Pyoderma?

Platelet-rich plasma (PRP) has shown potential in promoting wound healing and reducing inflammation, as seen in its use for chronic wounds and acne treatment. These properties suggest it could be beneficial for pyoderma, a skin condition that involves inflammation and infection. ^{1 2 3 4 5}

Is Platelet-Rich Plasma Therapy generally safe for humans?

Platelet-Rich Plasma Therapy (PRP) is generally considered safe, with adverse reactions being extremely rare. It has been used in various medical fields, including wound healing and hair growth, with a good safety profile. ^{2 4 6 7 8}

How is Platelet-Rich Plasma Therapy different from other treatments for pyoderma?

Platelet-Rich Plasma Therapy is unique because it uses a patient's own blood components to promote healing, which may reduce the risk of adverse reactions compared to traditional treatments like immunosuppressive drugs or steroids. Unlike other therapies that focus on reducing inflammation or infection, PRP Therapy aims to enhance the body's natural healing processes by concentrating growth factors at the wound site. ^{9 10 11 12 13}

Research Team

Benjamin H. Kaffenberger, MD

Principal Investigator

The Ohio State University- Dermatology

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of Pyoderma Gangrenosum (PG), characterized by painful skin ulcers. Participants must have a specific severity score, at least two qualifying ulcers, and no pregnancy if applicable. They should not be part of any other PG study and must consent to the trial's procedures.

Inclusion Criteria

You have provided written authorization to participate in the research activities.

I have been diagnosed with classic PG by a specialist.

Females of childbearing potential must present a negative pregnancy test both at screening and on Day 0.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intralesional PRP injections or topical PRP therapy at 0, 4, 8, and 12 weeks, with a third group receiving standard wound care only

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Platelet-Rich Plasma Therapy (Biological)

Trial Overview The study tests Platelet-Rich Plasma (PRP) therapy on chronic PG ulcers, using patients' own blood-derived growth factors to promote healing. The effectiveness of PRP as both a topical solution and injections directly into the ulcer area will be compared.

Participant Groups

Group I: Target ulcer Group 2(Topical PRP) Experimental Treatment 1 Intervention

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.

Group II: Target ulcer Group 1(Injectable PRP) Experimental Treatment 1 Intervention

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.

Group III: Target ulcer Group 3(No treatment) Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Ohio State University Wexner Medical Center Columbus, OH

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Patients Recruited

2,659,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Physician's Guide to Platelet-Rich Plasma in Dermatologic Surgery Part II: Clinical Evidence. Hausauer, AK., Humphrey, S.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma: a potential therapeutic tool for promoting hair growth. Li, ZJ., Choi, HI., Choi, DK., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet rich plasma injection versus topical erythromycin 2% in treatment of acne vulgaris. Ibrahim, ZA., Gheida, SF., El-Halaby, AR., et al.[2022]

Autologous platelet-rich plasma (PRP) may help improve the healing of foot ulcers in people with diabetes, but this is based on low-quality evidence from only two small studies involving 189 participants.

Overall, the effectiveness of PRP for treating chronic wounds remains unclear, as the majority of studies show low-quality evidence and are underpowered, highlighting the need for more robust clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Physician's Guide to Platelet-Rich Plasma in Dermatologic Surgery Part I: Definitions, Mechanisms of Action, and Technical Specifications. Hausauer, AK., Humphrey, S.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. Owczarczyk-Saczonek, A., Wygonowska, E., Budkiewicz, M., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of dermal injection of activated protein C for treatment of large chronic wounds secondary to pyoderma gangrenosum. Kapila, S., Reid, I., Dixit, S., et al.[2014]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy With Instillation and Dwell Time Used to Treat Pyoderma Gangrenosum: A Case Report. Woelfel, SL.[2021]

Negative pressure wound therapy (NPWT) was successfully used in an 83-year-old man with pyoderma gangrenosum, leading to significant wound healing and reduction of purulent discharge over 52 days of treatment.

The combination of NPWT and doxycycline was found to be safe and effective, suggesting that NPWT can be a valuable supportive treatment for managing wounds in pyoderma gangrenosum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy in Pyoderma Gangrenosum Treatment. Bazaliński, D., Karwiec, A., Kucharzewski, M., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pyoderma gangrenosum with topical factor XIII. Hoetzenecker, W., Guenova, E., Mitev, V., et al.[2013]

Ciclosporin was found to be more cost-effective than prednisolone for treating pyoderma gangrenosum, particularly for patients with larger lesions (≥ 20 cm²), showing a net cost reduction and improved quality of life.

For patients with smaller lesions, the cost-effectiveness of ciclosporin was less clear, with a cost-effectiveness estimate of £23,374 per quality-adjusted life year (QALY), indicating that treatment decisions should consider side effects and patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciclosporin compared with prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial. Mason, JM., Thomas, KS., Ormerod, AD., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Physician's Guide to Platelet-Rich Plasma in Dermatologic Surgery Part II: Clinical Evidence. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma: a potential therapeutic tool for promoting hair growth. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Platelet rich plasma injection versus topical erythromycin 2% in treatment of acne vulgaris. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Physician's Guide to Platelet-Rich Plasma in Dermatologic Surgery Part I: Definitions, Mechanisms of Action, and Technical Specifications. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Use of dermal injection of activated protein C for treatment of large chronic wounds secondary to pyoderma gangrenosum. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy With Instillation and Dwell Time Used to Treat Pyoderma Gangrenosum: A Case Report. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy in Pyoderma Gangrenosum Treatment. [2021]

12. France pubmed.ncbi.nlm.nih.gov

Treatment of pyoderma gangrenosum with topical factor XIII. [2013]

13. England pubmed.ncbi.nlm.nih.gov

Ciclosporin compared with prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial. [2022]