OBJECTIVE -To assess the application of autologous transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood mononuclear cells (PBMNCs) in the treatment of critical limb ischemia (CLI) of diabetic patients and to evaluate the safety, efficacy, and feasibility of this novel therapeutic approach. RESEARCH DESIGN AND METHODS -Twenty-eight diabetic patients with CLIwere enrolled and randomized to either the transplant group or the control group. In the transplant group, the patients received subcutaneous injections of recombinant human G-CSF (600 g/day) for 5 days to mobilize stem/progenitor cells, and their PBMNCs were collected and transplanted by multiple intramuscular injections into ischemic limbs. All of the patients were followed up after at least 3 months.RESULTS -At the end of the 3-month follow-up, the main manifestations, including lower limb pain and ulcers, were significantly improved in the patients of the transplant group. Their laser Doppler blood perfusion of lower limbs increased from 0.44 Ϯ 0.11 to 0.57 Ϯ 0.14 perfusion units (P Ͻ 0.001). Mean ankle-brachial pressure index increased from 0.50 Ϯ 0.21 to 0.63 Ϯ 0.25 (P Ͻ 0.001). A total of 14 of 18 limb ulcers (77.8%) of transplanted patients were completely healed after cell transplantation, whereas only 38.9% of limb ulcers (7 of 18) were healed in the control patients (P ϭ 0.016 vs. the transplant group). No adverse effects specifically due to cell transplantation were observed, and no lower limb amputation occurred in the transplanted patients. In contrast, five control patients had to receive a lower limb amputation (P ϭ 0.007, transplant vs. control group). Angiographic scores were significantly improved in the transplant group when compared with the control group (P ϭ 0.003).CONCLUSIONS -These results provide pilot evidence indicating that the autologous transplantation of G-CSF-mobilized PBMNCs represents a simple, safe, effective, and novel therapeutic approach for diabetic CLI. Diabetes Care 28:2155-2160, 2005D iabetes is a common chronic disease with significant morbidity and mortality. One devastating complication of diabetes is peripheral arterial disease (PAD) including critical limb ischemia (CLI), which may result in limb loss. There is no available permanent cure for diabetic CLI at present (1,2).Several investigations have indicated that in patients with diabetes, the circulating endothelial progenitor cells (EPCs) exhibit impaired proliferation, adhesion, and incorporation into vascular structures. The adverse metabolic stress factors are associated with reduced number and dysfunction of EPCs (3,4). In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of endothelial cells from preexisting vasculature (5). However, the EPCs resident within bone marrow and peripheral blood (6 -8) can also contribute to injury-induced and pathology-induced neovascularization. In animal models of diabetes, transplantation of bone marrow-or blood-derived EPC...

Conclusion:A paint with povidone-iodine by itself provides equal preoperative preparation of the abdominal wall as a scrub with povidoneiodine soap, followed by paint with povidone-iodine.Summary: The authors conducted a prospective randomized trial comparing scrub-and-paint with povidone-iodine soap followed by absorption with a sterile towel and subsequent paint with povidone-iodine versus surgical site preparation with paint only of povidone-iodine. The primary end point was wound infection at 30 days with wound infection defined as clinical signs of infection requiring therapeutic intervention. Excluded patients included those with active infection at the time of operation, known sensitivity to iodine, neutropenia, or insertion of prosthetic material during operation. Patients were randomized to a scrub-and-paint group or a paint only group with povidone-iodine.There were 115 patients randomized to the scrub-and-paint arm and 119 to the paint only arm of the trial. Patients were well matched with respect to surgical co-morbidities, age, operative time, drains, surgical procedure, and prophylactic antibiotic use. There were 12 wound infections in the scrub-and-paint patients (10%) and 12 wound infections in the paint only patients (10%).Comment: These data apply only to clean and clean-contaminated cases that do not involve placement of a prosthetic device. While the data are interesting, they do not provide guidance as to the proper surgical prep site technique for patients undergoing insertion of prosthetic grafts. The optimal surgical prep site technique with respect to insertion of prosthetic vascular grafts remains to be determined.

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