Fifteen years of experience in treating 2177 episodes of foot and leg lesions with the circulator boot. Results of treatments with the circulator boot.

OBJECTIVE: To determine the clinical effectiveness of the end-diastolic pneumatic compression boot and of local antibiotics in treating limb lesions associated with diabetes and peripheral arterial, venous, and neuropathic disease.

RESEARCH DESIGN AND METHODS: Office and hospital data were kept over 15 years on 2177 episodes of leg problems classified by the Wagner method for 1514 legs of 1035 patients largely referred because of failure of standard therapies. The fate of the untreated legs served as a controls when possible.

RESULTS: Healing or improvement of treated legs was seen above that in the literature in all Wagner categories and was significant (P < 0.001) compared to the "control" leg, which deteriorated in 38.7% of patients. Significant risk factors against a successful outcome included smoking, inability to walk, increased home distance from the boot center, loss to treatment, hemodialysis, a Wagner 4-5 classification, inoperable iliac occlusions, vascular procedures before or after referral for boot therapy, and an aggressive vascular surgeon. Neuropathy allowed successful treatment of lesions nondiabetic patients could not tolerate. Relapse was significantly more frequent in arteriosclerosis obliterans (ASO) patients with diabetes than without diabetes and in patients with neuropathy than in those with ASO. Diabetes did not affect the relapse rate in stasis disease. The overall percentage of legs having major amputations was low: 2.5% for diabetic legs at the initial treatment episode, 1.6% at the time of a relapse, and 4.1% after seeking treatment elsewhere. For nondiabetic patients, the respective risks were similar: 2.0%, 1.2%, and 2.9%.