Cath Lab Digest

More than 20.8 million persons in the US have diabetes mellitus; 2002 data estimates from the Centers for Disease Control and Prevention indicate that 82,000 lower limb amputations were performed in persons with diabetes.¹ Characteristic pathological changes attributed to autonomic and sensory neuropathy, often combined with vascular disease, lead to a high-risk situation for the person with diabetes.^2,3 Persons who have had such pathology and experience trauma or infection are at high risk for developing ulceration of the foot or ankle. Pecoraro et al⁴ documented the causal pathway of an amputation and found that in 81% of cases faulty wound healing contributed to amputation. Healthcare practitioners should utilize wound treatments that can reduce the rate of faulty wound healing; thus, preventing amputations.

According to the American Diabetes Association, more than 60% of nontraumatic lower-limb amputations occur in people with diabetes; the rate of amputation for people with diabetes is 10 times higher than for people without diabetes; Mexican Americans are 1.8 times as likely, non-Hispanic Blacks are 2.7 times as likely, and American Indians are three to four times as likely to experience lower-limb amputations. Amputation rates are 1.4 to 2.7 times higher in men than women with diabetes.⁵ Frykberg et al⁶ cites a 1998 study of 67,000 diabetes-related lower extremity amputation (LEA) and a similar study that resulted in a total of 984,000 hospital days, each length of stay averaging 15 days. Nonhealing diabetic foot ulcers and the resulting potential amputations present significant costs to the healthcare system and reduce patient quality of life.

The goal of diabetic foot ulcer treatment is to obtain wound closure as expeditiously as possible. Accepted therapeutic objectives and standards of care for diabetic foot ulcers include wound debridement, pressure relief in the wound area, appropriate wound management (eg, moist wound healing), infection management, ischemia management, medical management of comorbidities, and surgical management as needed.⁶ Emerging cellular therapies such as platelet-rich plasma (PRP) can have an adjunctive role in a standardized, quality treatment plan.

Platelet releasates, including multiple growth factors, have been used to treat wounds since 1985. In vivo prospective controlled studies as well as retrospective and cost effectiveness studies documenting the effect of this therapy have been published.^7-21 In vitro research has shown that platelets contain components and properties for wound healing²²; likewise, plasma contains fibrin matrix.²³

In 2001, Margolis²⁴ published a retrospective study analyzing the treatment results of 26,599 patients with diabetic neuropathic foot ulcers who had been treated with an autologous platelet releasate. The results suggest that platelet releasate provided with standardized care was more effective than standard care alone.

The purpose of the current study was to determine the safety and effectiveness of treating diabetic foot ulcers with PRP gel versus a control treatment (normal saline gel). The primary objective of the 12-week study was to compare the safety and incidence of complete wound closure between PRP gel- and control-treated wounds at the end of the study. Secondary objectives included comparing the rate of wound healing during the 12-week study and incidence of wound recidivism among healed ulcers during a 3-month follow-up period. Safety variables included adverse events, serious adverse events, and clinical laboratory tests.