Principal Investigator: Harold Brem, MD; Investigators: Glen Donovan, DPM, Indira Tuckler, DPM
Pressure ulcers in nursing home patients are common problems associated with significant morbidity and mortality. The purpose of this randomized, controlled double-blind study is to evaluate the tolerability and efficacy of platelet derived growth factors in platelet-rich plasma (PRP) as an adjunct to standard of care treatments for non-healing pressure ulcers in elderly patients and other patients with impaired wound healing. All stages of the wound healing process are controlled by a variety of growth factors and cytokines. In patients that have impaired wound healing, the amount of these growth factors are reduced. It’s been found that blood platelets have concentrated growth factors and other substances that have the potential to accelerate wound healing. These growth factors include PDGFaa, PDGFbb, PDGFab,TGFb1,TGFb2, and EGF as well as fibrin, fibronectin and vitronectin, which aid in cell adhesion.
Platelet-rich plasma (PRP) is a concentrated form of blood platelets, created by drawing blood and processing it in a centrifuge. To further facilitate the use of PRP to treat wounds, devices for processing PRP into PRP gel have recently become available. PRP can be obtained either from donor platelets or it can be autologous, meaning that it is derived from the patient’s own blood platelets—an approach that maximizes safety, since any chance of an adverse reaction is eliminated.
In this study, the Winthrop Wound Healing Center will use autologous PRP gel to treat non-healing pressure ulcers in patients with impaired wound healing. Although our study takes a special interest in patients 65 years and older, it is not limited to this age group. The study will follow 40 patients, all of them 18 years or older with a chronic non-healing pressure ulcer of greater than four weeks duration that has not adequately responded to standard therapy alone. The PRP gel will be applied to each patient’s wound topically every week for 12 weeks as long as the wound has not healed completely. There will also be a post-treatment visit once a week for 4 weeks to assure complete wound closure.
The entire study group will receive conventional standard of care wound treatment, including regular surgical debridement as needed. At the same time, half of the group will receive weekly applications of PRP gel, while the other half will receive applications of a placebo gel. The trial will determine the rate of wound healing in both groups by tracking the wound edge’s migration towards the center of the wound, using weekly digital photographs of wound measurements as well as weekly clinical assessments of the wound. Our hypothesis is that subjects treated with PRP gel as an adjunct to standard of care will heal at a faster rate than those treated with standard of care alone. The estimation is a 50% wound closure at week 6 and complete wound closure at week 12. Following complete closure of their wound, patients will visit our clinic once a week for four weeks to monitor closure, check for recurrence, and assess the PRP gel treatment in terms of long-term tolerability and safety.