Use of Novel Autologous Fibrin, Leukocytes, and Platelets in Patients With Diabetic Foot Wounds

Purpose: The investigators of this study provide an analysis of 15 patients treated with an autologous patch consisting of fibrin, leukocytes, and platelets. These patients have failed conventional treatment for diabetic foot wounds. In addition, the investigators will present data on patients with critical limb ischemia (CLI) and ankle-brachial index < 0.8.  The effects of fibrin and growth factors found in autologous plasma have been documented in wound healing and the formation of collagen. The autologous combined leucocyte, platelet, and fibrin patch is a novel treatment created by a unique centrifugation of autologous blood. The patch is applied to chronic diabetic foot wounds that have failed conventional wound care treatment alone.

Materials and Methods: The study presents 15 patients who failed at least 4 weeks of conventional wound care. In addition, some of these patients had proven CLI.  These patients continued to have a wound size of more than 50% of their original size at 4 weeks, despite weekly sharp debridement, local wound care, and total contact cast offloading. All patients presented with type II diabetes and peripheral arterial disease. Four patients were on hemodialysis. The patch was applied weekly; 1 to 20 applications per patient were done. Patient age range was 37 to 89 years. Wound sizes were analyzed weekly utilizing digital wound-imaging software.

Results: It was determined that after 1 application of a patch, in conjunction with sharpdebridement, local wound care and adjunctive total contact casting, the average decrease in length was 22.5%, width decrease was 16.45%, depth decrease was 4.5%, and total surface area decrease was 20.25%.

Conclusions: In our case series of 15 patients, the use of the autologous patch, in conjunction with local sharp debridement and offloading measures (total contact casting), has shown to decrease the size of diabetic foot wounds on a weekly basis, especially in the setting of chronic wounds lasting more than 4 weeks duration. Of the 15 patients evaluated, 11 patients completely healed with the use of the patch during the 20-week evaluation period. One patient underwent a minor (hallux) amputation and 3 patients have continued care with noted improvement in their wound on a weekly basis. Patients with CLI showed benefit from treatment, even in those not fully revascularized.