The association between medical risk factors and the outcome of foot ulcers was evaluated in 208 consecutive diabetic patients with severe peripheral vascular disease (systolic toe blood pressure < or = 45 mm Hg). All patients were treated and followed by the same foot care team. Eighty patients healed primarily, 83 healed after a minor or major amputation, and 45 died. The systolic toe blood pressure was higher among primary healed (30 +/- 13 mm Hg) compared with amputated (22 +/- 15 mm Hg; p < 0.001) and deceased patients (20 +/- 14 mm Hg; p < 0.001). The patients were comparable regarding age, sex, and diabetes and wound duration. Only 41 (19%) patients had intermitten claudication, whereas 153 (77%) lacked palapble pedal pulses, 36% of whom healed primarily. Rest pain occurred in 72 (33%) patients, 38 (47%) of whom had an amputation and 18 (25%) who healed primarily (p < 0.01). Peripheral edema and proteinuria were more common among patients who healed after amputation compared with those who healed primarily (p < 0.001 and p < 0.01, respectively). Signs of sensory neuropathy were found in 158 (77%) patients. There were no differences concerning cardiovascular disease, smoking habits, or short-term metabolic control between patients who healed primarily or after an amputation. In conclusion, diabetic patients with foot ulcers and severe peripheral vascular disease with low systolic toe blood pressure were not excluded from the possibility of primary healing. The most important risk factors for amputation were a systolic toe pressure of less than 30 mm Hg, peripheral edema, rest pain, and proteinuria.