Pyoderma GangrenosumNCT05984654
Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum
A study testing Platelet rich plasma therapy in people with Pyoderma Gangrenosum, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Platelet rich plasma therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Patients with hemodynamic instability, bleeding disorders, and/or platelet dysfunction syndrome.
- 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.
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- Systemic infection or active local infection requiring oral antibiotics within 2 weeks of Day 0.
- History of the following treatments:
- Patients taking anticoagulant medication.
- Changes (addition, discontinuation, or changes in dose) in immunosuppressive medication (including cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, apremilast, dapsone, or corticosteroids) and biologics (Anti-TNF or other biologic therapies) within 2 months of Day 0.
- Systemic corticosteroids > 20 mg per day (prednisone or prednisone equivalent) within 8 weeks of Day 0 or change in dose within 4 weeks of Day 0. Steroids may be tapered (although not increased above the Day 0 dose) during the trial as determined by the principal investigator.
- Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulators are also not permitted.
- Systemic antibiotics within 2 weeks of Day 0.
- Hyperbaric treatment within 4 weeks of Day 0.
- Investigational drug or investigational device within 4 weeks of Day 0.
- Other treatments not described above should be maintained at a stable dose and frequency throughout the study as best as possible.
- Major, general surgery within 3 months of screening, or anticipated general surgery during the study period.
- Pregnancy plans to become pregnant during the study, delivery within 3 months of screening, or breastfeeding.
- If previous use of cyclosporine or systemic corticosteroids, failure to have any stabilization/response is exclusionary. This potentially indicates the disease is not PG.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Prospective, Open-label, Randomized, Split-ulcer Trial to Evaluate the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Chronic Pyoderma Gangrenosum.
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.
Read the 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
- Being tested
- Platelet rich plasma therapy
- Keywords
- platelet rich plasma, pyoderma gangrenosum
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Target ulcer Group 1(Injectable PRP) | Experimental | 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. Receives: Procedure: Platelet rich plasma therapy |
| Target ulcer Group 2(Topical PRP) | Experimental | 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. Receives: Procedure: Platelet rich plasma therapy |
| Target ulcer Group 3(No treatment) | No intervention | Target ulcer in the control group will receive standard wound care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ulcers with complete healing or 50 % area reduction
Primary outcome will be the composite proportion of the target ulcers achieving either complete resolution or 50% reduction in the surface area at week 12 after treatment with either intralesional injectable or topical platelet-rich plasma therapy as compared to standard treatment
Measured: 12 weeks
Secondary outcomes (5)
Total surface area change
Analysis of change in total surface area of target/total ulcers from baseline to week 12 and week 16
Measured: Week 12 and week 16
Patient Global Assessment (PGA) change
Analysis of change Patient Global Assessment (PGA) from baseline until baseline to week 12 and week 16
Measured: Week 12 and week 16
Investigator Global Assessment (IGA) change
Analysis of change Investigator Global Assessment (IGA) x maximum wound dimension from baseline until baseline to week 12 and week 16
Measured: Week 12 and week 16
Patient pain perception
Analysis of change in patient pain perception using 10-point visual analog scale (VAS) from baseline to week 12 and week 16. This is a 10 point scale with higher scores indicating more severe pain.
Measured: Week 12 and week 16
Change in quality of life
Analysis of change in patient quality of life using the dermatology life quality index (DLQI) from baseline to week 12 and week 16.
Measured: Week 12 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start28 May 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: Did not obtain funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben H Kaffenberger, Ohio State University
- Investigators
- Benjamin H. Kaffenberger, MD, Principal investigator, The Ohio State University- Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984654
- Sponsor's protocol ID
- 2023H0207
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Randomized, Split-ulcer Trial to Evaluate the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Chronic Pyoderma Gangrenosum.
- ClinicalTrials.gov ID
- NCT05984654
- Acronym / sponsor ID
- 2023H0207
- Conditions
- Pyoderma Gangrenosum
- Keywords
- platelet rich plasma, pyoderma gangrenosum
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not obtain funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Target ulcer Group 1(Injectable PRP) | Experimental | Procedure: Platelet rich plasma therapyUnder 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. |
| Target ulcer Group 2(Topical PRP) | Experimental | Procedure: Platelet rich plasma therapyUnder 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. |
| Target ulcer Group 3(No treatment) | No intervention | –Target ulcer in the control group will receive standard wound care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
- Patients with hemodynamic instability, bleeding disorders, and/or platelet dysfunction syndrome.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasma therapyApproximately 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. | Procedure or surgery | Target ulcer Group 1(Injectable PRP), Target ulcer Group 2(Topical PRP) |
Primary outcome
Proportion of ulcers with complete healing or 50 % area reduction
Time frame: 12 weeks
Primary outcome will be the composite proportion of the target ulcers achieving either complete resolution or 50% reduction in the surface area at week 12 after treatment with either intralesional injectable or topical platelet-rich plasma therapy as compared to standard treatment
5 secondary outcomes
Total surface area change
Time frame: Week 12 and week 16
Patient Global Assessment (PGA) change
Time frame: Week 12 and week 16
Investigator Global Assessment (IGA) change
Time frame: Week 12 and week 16
Patient pain perception
Time frame: Week 12 and week 16
Change in quality of life
Time frame: Week 12 and week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin H. Kaffenberger, MD principal investigator
The Ohio State University- Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma therapy in people with Pyoderma Gangrenosum, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ulcers with complete healing or 50 % area reduction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.