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The study was approved by the Institutional Review Board at Scott and White Hospital. We consented and enrolled 30 diabetic patients with foot wounds to IRS1 receive 80 mmHg of NPWT with a gauze dressing interface for up to 4 weeks, followed by a 1-week posttreatment evaluation (EZCare, Smith and Nephew Medical, London, UK). The NPWT dressing was changed every 3 days. Patients with exposed bone or tendon had exposed areas covered with protective nonadherent gauze prior to application of the dressing and NPWT. The primary outcome was 50% wound area reduction. ��Responders�� were defined as subjects that achieved at least a 50% wound area reduction after 4 weeks of therapy and ��nonresponders�� as subjects with included subjects with diabetes who were 18 years of age or older and with an acute or surgical wound deemed suitable for treatment with NPWT. We excluded patients with untreated osteomyelitis and presence of necrotic tissue and patients who were pregnant or planning to become pregnant. Patients who interrupted the evaluation treatment for longer than 48 hours were withdrawn from treatment. Digital photos and wound measurements of length, width, and depth were obtained once a week. Photos were taken of each wound at each dressing change. Wound volume was calculated using clinical measurements and check details the formula for volume of an ellipsoid; the volume is V = 4/3 LWD��, where selleck L is the length of the long axis, W is the width, and D is the depth. Wound area and volume reduction were calculated as percentage change from baseline wound size. Statistical analysis included 2-way analysis of variance with repeat measures. Patients who received off-loading used either a removable cast boot or a postop shoe based on the patient��s postural stability and wound location. In addition, patients were prescribed wheelchairs, crutches, or canes. Results Of the 30 patients enrolled in the study, 63% were male and the average age was 55 �� 11.8 (range 89-32). All of the study subjects had type 2 diabetes and diabetes-related foot wounds, with a mean duration of diabetes of 14.5 �� 10.7 years and a mean glycated hemoglobin of 7.9 �� 1.64. The average size of foot wounds was 8.2 �� 8.1 cm2. During the study there was 1 serious adverse event that was not device related; 20% of patients withdrew from the study, and 13.3% healed. Demographics for responders (��50% wound area reduction) and nonresponders (