A new platelet-rich fibrin (PRF) matrix is becoming a promising and affordable alternative for treating chronic diabetic ulcers (diabetic foot), a pilot study conducted in São Paulo, Brazil, suggests.
The authors used a third-generation PRF (Progressive PRF or PRO-PRF) created by researchers from the Federal University of Juiz de Fora (UFJF). PRF is a concentrate obtained by centrifuging the patient’s blood and contains no additives. According to Rafael Furst, MD, and João Antonio Correa, MD, vascular surgeons affiliated with the ABC School of Medicine, who conducted the study and spoke with Medscape Portuguese Edition, the product can be considered an autologous healing biomaterial that contains white blood cells, platelets, and a broad array of crucial proteins in a dense matrix.
The study was published in May in PLoS One.
In this prospective and interventional pilot study, the authors used PRO-PRF on three male patients with type 2 diabetes. Their average age was 54 (51-57) years, and they had chronic ulcers on the lower limbs associated with complex and difficult-to-control diabetes. Patients with ulcers of other etiologies were excluded from the study.
Researchers followed a peer-reviewed protocol with the following steps: preparation of the lesion, preparation of PRO-PRF, and application of PRO-PRF and protection of the lesion. Treatment took place between May and August 2022.
The ulcers did not show ischemic macroangiopathy, active infection after debridement, or limitations related to the area, depth, or type of exposed tissue. Moreover, they had previously been treated with wound care, systemic antibiotic therapy, and photodynamic therapy, varying between two and four sessions.
Seven PRO-PRF membranes were applied between two and four sessions. In total, 11 liquid-phase infiltrations were applied between three and four sessions. Participants were assessed weekly.
Until the beginning of the study, the existing PRF matrices (first and second generation) were not viable for treating more extensive lesions, despite their action on forming membranes with good cellular quality. However, according to Furst and Correa, the product developed by the UFJF oral and maxillofacial surgery team can create a three-dimensional membrane of varying sizes that adapts to each patient’s needs.
After the first session, the authors observed an average reduction in lesion area of 36.6%. After the second and third weeks, the average reductions were 22% and 39%, respectively. All patients achieved complete healing of the lesion within 9 weeks, on average.
Furst and Correa also state: “All study patients progressed favorably, with a considerable acceleration of the healing process. Nevertheless, they continued to be regularly followed since, given the nature of the disease, there is the possibility of relapse.”
New Studies Underway
In addition to its efficacy, another positive aspect of the intervention is its cost. The total cost of the pilot study was between $200 and $800 USD, depending on the number of sessions needed. The researchers said these numbers are lower than other tissue-regeneration matrices. They also pointed out that this factor could favor the future implementation of this strategy in the Brazilian public health system.
The group is pursuing additional lines of investigation. “We already have more than one article in the final phase describing a series of 30 cases, and we are simultaneously designing a randomized study comparing third-generation PRF to standard dressings,” Furst and Correa affirmed. “This is a tremendously promising line of research.”
The PRO-PRF matrices were developed in a laboratory using blood samples drawn from patients through venous puncture into vacuum-sealed test tubes. “After centrifuging using a protocol that gradually increases the number of rotations, we obtained the concentrate in a liquid phase and then the membrane itself; both can be applied immediately. The process is simple, easily reproducible, and affordable,” said Furst and Correa. The study was conducted at the City of Santo André Hospital Center (CHMSA) in conjunction with Roberto Fech, DDS, a dental surgeon specializing in oral and maxillofacial trauma, and his team.
This article was translated from the Medscape Portuguese Edition .
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