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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Tropocells Autologous Platelet-rich Fibrin (PRF) to heal foot ulcers in people with diabetes. Researchers aim to determine if this treatment can safely and effectively close wounds that have been difficult to heal. Participants will receive treatment and undergo monitoring over several months to assess improvement. This study targets adults with Type 1 or Type 2 diabetes who have had a non-infected foot ulcer for at least 30 days. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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.

Is there any evidence suggesting that Tropocells Autologous Platelet-rich Fibrin (PRF) is likely to be safe for humans?

Studies have shown that treatments like Tropocells Autologous Platelet-rich Fibrin (PRF) are generally safe for treating diabetic foot ulcers. Research indicates that similar treatments, such as platelet-rich plasma, are well-tolerated by patients. Most patients did not experience serious side effects, and the treatment effectively helped heal ulcers.

Although this specific treatment remains under study, the current trial phase suggests earlier studies have demonstrated sufficient safety to proceed. This indicates some confidence in its safety, though additional data will help confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for foot ulcers?

Researchers are excited about TropoCells Autologous Platelet-rich Fibrin (PRF) because it offers a novel approach to healing chronic foot ulcers. Unlike typical treatments that involve regular wound care and off-loading techniques, TropoCells PRF is derived from the patient's own blood and uses growth factors to stimulate tissue repair and regeneration directly at the wound site. This personalized treatment harnesses the body's natural healing processes, potentially speeding up recovery and improving outcomes for individuals with foot ulcers.

What evidence suggests that Tropocells Autologous Platelet-rich Fibrin (PRF) might be an effective treatment for diabetic foot ulcers?

Research has shown that a gel made from a person's own blood, such as Tropocells Autologous Platelet-rich Fibrin (PRF), can help treat diabetic foot ulcers. This treatment promotes healing by encouraging new tissue growth and improving blood flow to the wound. A review of several studies found that treatments using a patient's own blood significantly improved the healing of these ulcers. In this trial, participants will receive the Tropocells Autologous PRF system, which uses the patient's blood to create a gel that accelerates healing. Early research suggests this method is both effective and safe for healing diabetic foot ulcers. ^{1 2 6 7 8}

Who Is on the Research Team?

Adrianne P Smith, MD

Principal Investigator

Sanogenix Medical, LLC

Marcus L. Gitterle, MD

Principal Investigator

WoundCentrics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06810726

Evaluate Use of Tropocells(R) Autologous Platelet-rich ... The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9678626/

Autologous platelet-rich gel in the treatment of diabetic foot ... This study retrospectively investigated the effectiveness and safety of autologous platelet-rich gel (APRG) for the treatment of diabetic foot ulcers (DFU).

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/573835

Evaluate Use of Tropocells(R) Autologous Platelet-rich ... The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352320425000318

A comparative review of PRP, PRF, and CGF with case ... This study reviews the preparation methods, biological mechanisms, and clinical efficacy of three generations of PCs: platelet-rich plasma (PRP), platelet-rich ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03854-x

Efficacy and safety of autologous platelet-rich plasma for ... Efficacy and safety of autologous platelet-rich plasma for diabetic foot ulcer healing: a systematic review and meta-analysis of randomized ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10197861/

Efficacy and safety of autologous platelet-rich plasma for ... In the literature, 22 studies have documented the healing rate of Au-PRP compared to conventional treatment for DFU. The ulcer healing rate for ...

7. fdaaa.trialstracker.net fdaaa.trialstracker.net/trial/NCT06810726/

NCT06810726: An ongoing trial by Estar Medical dba ... Full data ; EVALUATION OF THE SAFETY AND THE CLINICAL PERFORMANCE IN TREATMENT OF CHRONIC DIABETIC FOOT ULCER, WITH THE TROPOCELLS®, BASED AUTOLOGOUS PLATELET ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38060413/

Efficacy and safety of autologous platelet-rich plasma for ... Based on the findings of this review and meta-analysis, Au-PRP is an effective and safe adjuvant therapy for DFUs.