Platelet Rich Plasma for Foot Ulcer

Recruiting at 1 trial location

Overseen By Tarek Ibrahim, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Estar Medical dba Medical Technologies, LTD

Must not be taking: Systemic steroids, Immunosuppressives

Disqualifiers: CKD Level G5, Sepsis, Osteomyelitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or certain treatments that affect wound healing, you may need to stop them 30 days before the study. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Tropocells Autologous Platelet-rich Fibrin (PRF) for foot ulcers?

Research shows that using platelet-rich plasma (PRP), which is similar to PRF, can help heal diabetic foot ulcers. Studies have found positive outcomes in wound healing when PRP is used, although results can vary due to differences in how PRP is prepared. ^{1 2 3 4 5}

Is platelet-rich plasma safe for treating foot ulcers?

Research shows that platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) have been used safely in treating diabetic foot ulcers and other chronic wounds. These treatments are generally considered safe, but results can vary due to differences in how they are prepared. ^{1 2 3 5 6}

How is the treatment Tropocells Autologous Platelet-rich Fibrin (PRF) unique for foot ulcers?

Tropocells Autologous Platelet-rich Fibrin (PRF) is unique because it uses the patient's own blood components to create a fibrin matrix that promotes healing, unlike standard treatments that may not use autologous (self-derived) materials. This approach can enhance wound healing by providing a scaffold for cell growth and delivering growth factors directly to the ulcer site. ^{1 3 5 7 8}

What is the purpose of this trial?

The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\[s\] it aims to answer \[is/are\]: Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group. Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System. Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.

Research Team

Adrianne P Smith, MD

Principal Investigator

Sanogenix Medical, LLC

Marcus L. Gitterle, MD

Principal Investigator

WoundCentrics

Eligibility Criteria

This trial is for males and females aged 18-80 with Type 1 or Type 2 Diabetes Mellitus who have chronic neuroischemic diabetic foot ulcers graded as mild to moderate (Wagner Grade II). Participants should not show at least a 20% wound reduction during a run-in phase to qualify for the active treatment.

Inclusion Criteria

I don't have signs of infection in my wound or limb.

I use a special boot or device to relieve pressure on my foot.

I am able to bear children, not pregnant, and will use birth control or abstain during the trial.

Exclusion Criteria

I have not had sepsis in the last 2 weeks.

I have a history of blood clotting issues or am on IV heparin.

I have had radiation or chemotherapy in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 visits (in-person)

Run-In

Participants with chronic diabetic foot wounds undergo a 2-week run-in phase with standard of care including nutritional supplementation, wound assessment, and care.

2 weeks

2 visits (in-person)

Active Treatment

Participants receive weekly treatment with Tropocells Autologous PRF System and standard of care for wound care.

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored to ensure wounds remain closed at 1 month and 3 months post-treatment.

3 months

2 visits (in-person)

Treatment Details

Interventions

• Tropocells Autologous Platelet-rich Fibrin (PRF)

Trial Overview The study tests Tropocells Autologous Platelet-rich Fibrin (PRF) in wound care. It involves an initial run-in phase, followed by up to 12 weeks of treatment with PRF for those whose wounds don't shrink by at least 20%, and then follow-up after wound closure at one and three months.

Participant Groups

Group I: T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcers Experimental Treatment 1 Intervention

During Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months.

Who Is Running the Clinical Trial?

Estar Medical dba Medical Technologies, LTD

Lead Sponsor

Trials

1

Recruited

30+

WCG IRB

Collaborator

Trials

2

Recruited

1,000+

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

A case series of autologous platelet-rich plasma injection in treating chronic ulcers conducted in Saudi Arabia. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of autologous platelet-rich plasma for diabetic foot ulcers: a systematic review and meta-analysis. [2023]

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

Autologous Platelet-Rich Plasma for Diabetic Foot Ulcer. [2021]

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

Management of chronic diabetic foot ulcers using platelet-rich plasma. [2022]

5. Indonesia pubmed.ncbi.nlm.nih.gov

Wound Healing in Diabetic Foot Ulcer Patients Using Combined Use of Platelet Rich Fibrin and Hyaluronic Acid, Platelet Rich Fibrin and Placebo: An Open Label, Randomized Controlled Trial. [2022]

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

Utility of platelet rich fibrin gel therapy in nonhealing ulcer secondary to ecthyma gangrenosum. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Use of platelet rich plasma and hyaluronic acid on exposed tendons of the foot and ankle. [2010]

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

Use of autologous platelet rich fibrin-based bioactive membrane in pressure ulcer healing in rats. [2022]