Abstract
Clinical records of 94 chronic venous ulcer patients (treated at two independent specialty centers) were included in a retrospective analysis to evaluate the effects of standard of care, plus continued intermittent pneumatic compression (IPC) therapy during and after wound closure. Both clinical centers employed the Venous Clinical Severity Score (VCSS) to monitor clinical outcomes. IPC application varied slightly between the two clinical sites. One wound care center in South Florida treated patients (n=60) using a four chamber gradient IPC at 50 mmHg for 45 minutes BID (five days on and two days off). The other center in New York treated patients (n=34) with a four chamber gradient IPC at 55 mmHg for one hour BID. Both wound care centers applied IPC therapy using standard adjustable (95.3cm) half-leg sleeves. Both centers used the same IPC therapy pump (Bio Compression Model 2004, Bio Compression Systems Inc., Moonachie, NJ). All patients were seen weekly for standard evaluations and reapplication of compression bandages. Patient record analysis was for 12 consecutive weeks beginning at baseline (prior to IPC application). VCSS scores were recorded at monthly intervals. The incidence of ulcer healing was 80% after 12 weeks of IPC therapy. Symptomatic improvement was noted in every VCSS parameter measured. In the category of pain, there was a significant difference in the number of patients reporting severe pain before and after IPC therapy (42 at baseline vs. 0 after 12 weeks of IPC [p=0.004]). Also, the number of patients reporting no pain before and after IPC therapy increased by 67% (p<0.001). In the category of edema, significant improvement was noted after 12 weeks of IPC therapy in patients that had severe edema at baseline (p=0.017) and also in the number of patients where the edema resolved (p=0.004). Severe inflammation was significantly reduced in all study patients (p=0.022) and completely resolved in 60 of the 94 patients (63.8%, p<0.001). The incidence of ulcer healing was 80% after 12 weeks of IPC therapy. Significant symptomatic improvement was noted in every VCSS parameter.
Highlights
Venous leg ulcers (VLU) are chronic wounds that develop as a result of long-standing venous hypertension and chronic venous insufficiency (CVI) [1,2,3,4]
These two clinical sites were selected because both measured clinical outcomes for their CVI patients using the Venous Clinical Severity Scoring System (VCSS), and both sites prescribed intermittent pneumatic compression (IPC) therapy to treat recalcitrant VLUs that did not heal with static compression alone
Patients affected with acquired lymphedema and dermal fibrosis, or patients that have a previous history of DVT, do not respond to traditional compression bandaging [29]
Summary
Venous leg ulcers (VLU) are chronic wounds that develop as a result of long-standing venous hypertension and chronic venous insufficiency (CVI) [1,2,3,4]. Following a systematic review of IPC treatment for CVI and VLU [20], The Centers for Medicare and Medicaid Services (CMS) concluded that the body of evidence for IPC was not robust enough to merit reimbursement coverage across the board for the treatment VLU They issued a decision that IPC would only be covered for patients with refractory edema with significant ulceration of the lower extremities after a six month trial of standard therapies, such as compression bandages and stockings, had failed. Our goal, in this observational retrospective review, was to measure and compare clinical outcomes and physical function in VLU patients who were treated with IPC therapy (according to CMS coverage guidelines). This review involves VLU patients from two independent clinical centers who were treated with IPC and had outcomes measured using the same instrument (VCSS) as an evaluative tool to record changes in disease severity over time and in response to treatment
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