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17.1 Intermittent, gradient, pneumatic compression plus standard compression for hard to heal venous ulcers in subjects with secondary lymphedema and chronic venous insufficiency: analysis of a prospective, randomized clinical trial
Oscar M. Alvarez, PhD; Linda Waltrous, RN, BSN; Martin Wendelken, DPM, RN; Lee Markowitz, DPM; Rachelle Parker, MD; Emannuel Pappous, MD; Center for Curative and Palliative Wound Care
Thirty-four subjects with secondary lymphedema, chronic venous insufficiency, and hard to heal lower leg ulceration (> 1-year-old and > 20 cm2 surface area) were treated with either intermittent, gradient, pneumatic compression (IPC* n = 17) plus standard care or standard care alone (control). Standard care consisted of a nonadherent primary wound dressing plus a 4-layer compression bandage (4-LB** n = 17). The mean age and size of the ulcers were 1.8 years and 34 cm2 respectively and did not differ significantly between groups. IPC was performed using a 4-chamber pneumatic leg sleeve and gradient, sequential pump. All pumps were calibrated to a pressure setting of 40Ð50 mmHg on each subject and treatments were for 1 hour twice daily. Evaluations were performed weekly to measure edema, local pain, degree of wound granulation, and wound healing (incidence of complete closure and rate of healing from wound surface area measurements). The median time to wound closure by 8 months was 135 days for the IPC-treated group and 198 days for the control group (P = 0.039). The rate of healing was 1.1 ± 0.4 mm/day for the control group and 2.3 ± 0.7 mm/day for the group treated with IPC (P = 0.026). When compared to subjects treated with standard care, the group treated with IPC reported less pain at each evaluation point for the first 6 weeks of the trial. At weeks 1, 2, and 3 the visual analog pain scores were significantly lower for the IPC-treated group (P < 0.05). During the first 8 weeks, the IPC-treated group had an 8.9% mean decrease in leg edema compared to 4.5% for the group treated with compression bandages alone. These results suggest that IPC is a valuable adjunct to standard care in the management of chronic, difficult to heal, large, or painful venous ulcers. |