political views [0.65,:15 mg/day), radiation therapy or chemotherapy; or enrollment in studies within the past 30 days for investigational devices or within the past three months for investigational drugs related to wound healing. Extremities with multiple ulcers were enrolled; however, only one ulcer per extremity was studied. Non-study ulcer care was not specifically defined. Study ulcer care was defined for the treatment (Apligraf and compression therapy) and control (zinc paste gauze and compression therapy), treatment groups in two phases: Active Phase (0-8 weeks): All patients received: i) a non-adherent, ii) a non-occlusive, and iii) a therapeutic compression dressing on day 0, mid-week during the first week (day 3-5), and at weeks 1-8. Control treated patients also received zinc impregnated gauze at each visit. All Apligraf patients received Apligraf on day 0. At the day 3-5 and weeks 1, 2, and 3 visits, if less than 50% Apligraf take was observed, then patients received an additional application of Apligraf. Patients were not allowed to receive more than 5 Apligraf applications total. Maintenance Phase (8-52 weeks): Closed-ulcer extremities received non-specified elastic compression stockings. Open-ulcer extremities continued with dressing changes. Wound closure was defined as 100% epithelialization without drainage and assessed by clinical observation at visits on day 0, day 3-5, weekly from weeks 1-8, months 3 and 6 after initial treatment application or until wound closure was achieved. Additional follow-up visits were 9 and 12 months after initial treatment. VLU Study Results The incidence of VLU wound closure at set visits up to 6 months is presented below as the raw data results (Figure 1) and the results after adjustment for pooled center, baseline ulcer duration, and baseline area (Figure 2). VLU Ulcer recurrence At six months, the incidence of VLU recurrence was 8.3% (6/72) for Apligraf- and 7.4% (4/54) for control-treated patients. The incidence of VLU recurrence by 12 months was 18.1% (13/72) in the Apligraf group and 22.2% (12/54) in the control group. VLU Suspected wound infection In the VLU effectiveness cohort, there were 33/130 (25.4%) Apligraf-treated and 15/110 (13.6%) control-treated ulcers with suspected wound infection. While the overall incidence of wound infection was higher in the Apligraf arm, the incidence of wound closure (Figures 1 and 2) was also higher for Apligraf-treated patients. VLU Baseline status impact on wound closure The impact of VLU patient baseline status on wound closure was evaluated for the patient populations above and below the median values for ulcer duration and ulcer size as well as for baseline IAET Ulcer Stage, the presence of diabetes and a patient's Ankle Brachial Index. The results of these analyses are displayed in Table 4. Table 4 Pre-Treatment Status and Wound Closure VLU Effectiveness Cohort (n=240 patients) Pre-Treatment Status Number and Percent of Wound Closure by 6 months Patient Condition No. and (%) Apligraf Pts. No. and (%) Control Pts. Apligraf Control Total 130 Patients 110 Patients 72 (55.4%) 54 (49.1%) Ulcer Duration] FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates you got
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