Platelet-Rich Fibrin for Chronic Wounds
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called TropoCells® Autologous Platelet-Rich Fibrin (PRF) to aid in healing chronic wounds that resist natural healing, such as leg ulcers and pressure sores. The trial aims to determine if PRF is safe and effective for these wounds. Individuals with a non-infected, mild-to-moderate open wound for at least 30 days, like a leg or pressure ulcer, who have tried standard care without significant healing, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to important medical advancements.
What prior data suggests that TropoCells® Autologous Platelet-Rich Fibrin (PRF) is safe for treating chronic wounds?
Research has shown that TropoCells® Autologous Platelet-Rich Fibrin (PRF) is generally safe for treating hard-to-heal wounds like diabetic foot ulcers and pressure sores. TropoCells PRF uses a patient’s own blood to create a gel that aids in wound healing. This method has been safely used for over 30 years in other treatments for bones and soft tissue.
In studies, TropoCells PRF has shown promise in healing wounds without major side effects. The treatment uses the body's own platelets, tiny cells in the blood that help with healing, to speed up recovery. Studies have reported no major negative effects, suggesting it is safe to use.
Since this trial is in an early phase, the main goal is to ensure the treatment's safety for people. Researchers are closely monitoring any side effects. However, the long history of using platelet therapies supports its safety in this new application.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for chronic wounds, which often involve dressings, topical antibiotics, or regular debridement, TropoCells® Autologous Platelet-Rich Fibrin (PRF) offers a unique approach by using the patient's own blood to create a fibrin matrix rich in growth factors. This method not only promotes faster healing by enhancing tissue regeneration but also reduces the risk of infection since it's derived from the patient’s own body. Researchers are excited about this treatment because it provides a targeted, natural way to accelerate healing in chronic wounds such as leg ulcers, pressure ulcers, and diabetic ulcers, potentially improving outcomes for patients who struggle with these persistent conditions.
What evidence suggests that TropoCells® Autologous Platelet-Rich Fibrin (PRF) might be an effective treatment for chronic wounds?
Research has shown that Tropocells® Autologous Platelet-Rich Fibrin (PRF), which participants in this trial will receive, can effectively heal chronic wounds. One study found that PRF reduced the healing time for chronic venous leg ulcers. Another study demonstrated that PRF accelerated ulcer healing compared to other treatments. PRF uses the patient's own blood to create a treatment that speeds up wound healing. It has been successfully used alongside standard treatments to improve healing in chronic wounds that are difficult to heal. Overall, early research suggests that PRF holds promise for treating various types of chronic wounds.16789
Are You a Good Fit for This Trial?
Adults aged 18-80 with chronic non-healing wounds present for at least 30 days can join this trial. They must have certain levels of prealbumin, platelets, hemoglobin, and HbA1C within specified ranges. People with severe illnesses, recent participation in other trials, substance abuse, known sensitivities to PRF components or blood products are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Tropocells® Autologous Platelet-Rich Fibrin (PRF) is topically applied to chronic, non-healing wounds
Follow-up
Participants are monitored for complete wound closure and safety
What Are the Treatments Tested in This Trial?
Interventions
- TropoCells(R) Autologous Platelet-Rich Fibrin (PRF)
Trial Overview
The trial is testing TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) on various types of chronic wounds to assess its safety and effectiveness in promoting healing. Participants will receive PRF treatment and their wound closure progress will be monitored.
How Is the Trial Designed?
1
Treatment groups
Active Control
Tropocells® Autologous Platelet-Rich Fibrin (PRF) to be topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically debrided wounds", intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional.
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Who Is Running the Clinical Trial?
Estar Medical dba Medical Technologies, LTD
Lead Sponsor
Global Clinical Research Institute
Collaborator
Citations
Using TropoCells(R) Autologous Platelet-Rich Fibrin (PRF ...
Autologous Platelet-Rich Plasma Reduces Healing Time of Chronic Venous Leg Ulcers: A Prospective Observational Study. Adv Exp Med Biol. 2019 ...
A Comparative Study on Therapeutic Efficacy of ...
PRFM resulted in relatively faster ulcer healing compared with other modalities. Keywords: Collagen particles, epidermal growth factor, nonhealing ulcer, ...
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 for ...
Tropocells Autologous PRF for Chronic Diabetic Foot Ulcers
This clinical trial focuses on evaluating a treatment for people with chronic diabetic foot ulcers, a common problem for those with diabetes.
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journals.lww.com
journals.lww.com/jdyu/fulltext/2024/13010/evaluation_of_autologous_platelet_rich_fibrin_in.13.aspxEvaluation of autologous platelet rich fibrin in chronic non
PRF can be used as an adjuvant along with standard treatment in the management of chronic non healing ulcers to reduce the duration of healing.
Wound Management
Ideal for non-healing wounds like diabetic foot ulcers, venous ulcers, and pressure sores where traditional treatments have been ineffective.
Tropocells® PRF
Tropocells PRF is an autologous polymerised fibrin scaffold that consists of large quantity of platelet cytokines, growth factors and chemokines.
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 ...
9.
ctv.veeva.com
ctv.veeva.com/study/using-tropocells-r-autologous-platelet-rich-fibrin-prf-to-treat-chronic-non-healing-woundsUsing TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) to ...
Chronic wounds present for at least thirty (30) days meeting classification as, mild to moderate severity, open exuding wound, including, leg ...
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