Investigators: Harold Brem, MD, Scott Gorenstein, MD, Nicole Nadel, DO
Lower-limb ulcers are a serious complication of diabetes associated with an increased risk of infection, gangrene and amputation. 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 diabetic ulcers in 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. 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. In this study, which is currently enrolling patients, the Winthrop Wound Healing Center will use donor-derived PRP to treat non-healing lower extremity wounds of diabetic patients with impaired wound healing. Patients in the trial’s PRP group will receive weekly injections of donor-derived PRP, using plasma obtained through the Red Cross that is shipped overnight to Winthrop from donor sites in New York City. Patients in the control group will receive injections of a saline placebo instead.
The entire study group will receive conventional standard of care wound treatment, including regular surgical debridement as needed. 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 injected donor-derived PRP as an adjunct to standard of care will heal at a faster rate than those treated with standard of care alone.