Platelet-Rich Plasma Therapy for Pyoderma

Overseen By Manjit Kaur, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

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

Disqualifiers: Malignancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

10 Participants Needed

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.

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

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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

Platelet-rich plasma (PRP) shows promising results in treating conditions like androgenetic alopecia and improving wound healing, but the evidence is mostly based on smaller studies rather than large randomized controlled trials.

There is a need for more standardized research practices in PRP studies, including consistent terminology and protocols, to enhance the reliability of outcomes and establish PRP as a leading treatment in dermatology.

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]

Activated platelet-rich plasma (PRP) significantly enhances the proliferation of dermal papilla (DP) cells and stimulates key signaling pathways (ERK and Akt), which are important for hair growth.

In an in vivo study with mice, injections of activated PRP led to a quicker transition from the resting phase (telogen) to the growth phase (anagen) of hair follicles compared to control mice, suggesting its potential effectiveness in promoting hair growth.

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]

In a study of 40 patients with inflammatory acne, platelet-rich plasma (PRP) injections showed significantly better improvement compared to topical erythromycin, with 55% of patients experiencing good to excellent results.

PRP treatment not only led to higher patient satisfaction but also resulted in a lower recurrence rate of acne lesions, making it a safe and effective alternative to traditional systemic treatments.

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]

Platelet-rich plasma (PRP) shows promising results in treating conditions like androgenetic alopecia and aiding in wound healing, but the evidence is mostly based on smaller studies rather than large randomized controlled trials.

There is a need for more standardized research protocols and consistent terminology in PRP studies to improve clinical outcomes and establish best practices in dermatology.

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]

A 41-year-old woman developed serum sickness disease (SSD) after her third platelet rich plasma (PRP) treatment for alopecia areata, highlighting a rare but serious adverse reaction to this generally safe procedure.

The case suggests that individuals with active autoimmune diseases, like alopecia areata, may face increased risks from PRP treatments, indicating that such conditions should be considered as significant contraindications.

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]

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

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]

A systematic review of nine randomized controlled trials involving 325 participants found no significant difference in the healing of chronic wounds when comparing autologous platelet-rich plasma (PRP) to standard treatments or placebo.

While some results showed a higher percentage of wound area healed with PRP in mixed chronic wounds, overall evidence does not support the efficacy of PRP for chronic wound treatment, 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]

Activated protein C (APC) treatment in two patients with pyoderma gangrenosum resulted in significant reductions in ulcer size, with one patient experiencing a 78.9% decrease and the other a 70.0% decrease over 12 weeks.

Both patients reported complete pain relief (100% decrease in pain scores), suggesting that APC may be an effective therapeutic option for chronic skin ulcers associated with pyoderma gangrenosum, despite the study's small sample size.

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]

Negative pressure wound therapy with instillation and dwell time (NPWTi-d) combined with a specialized foam dressing effectively reduced necrotic tissue and promoted granulation in a patient with pyoderma gangrenosum, showing significant improvement by day 25.

This treatment approach was safe for the patient, as no pathergy phenomenon occurred, which is often a concern in pyoderma gangrenosum cases.

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]

In a case series involving 6 patients with severe pyoderma gangrenosum, treatment with topical coagulation factor XIII led to significant reductions in ulcer size, demonstrating its efficacy in promoting wound healing.

The treatment was well tolerated with no notable adverse effects, suggesting that topical factor XIII could be a safe adjunct therapy alongside standard immunosuppressive treatments for pyoderma gangrenosum.

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]