Authors' objectives:

The Circulator Boot Corporation™ (Circulator Boot Corp.; Malvern, PA) contacted the Department of Veterans Affairs (VA) to consider the use of the Circulator Boot™ in the Veteran population for preventing amputation caused by vascular insufficiency. The Circulator Boot™ is a form of end-diastolic pneumatic compression therapy that employs cardio-synchronous compression to improve perfusion to the leg and foot to treat chronic ulcers and pain and prevent amputation1. The manufacturer claims that the Circulator Boot™ requires minimal training and can be performed in almost any clinical setting.

Authors' recommendations: The systematic reviews included in this report considered comparative studies of a range of mechanical compression devices for the prevention or treatment of CVI. Labropoulos (2002) also included observational studies (case series) of the Circulator Boot™; the largest represented 15 years of cumulative experience with 1,035 subjects with a range of arterial and venous insufficiencies and associated complications. Two subsequently published studies from this investigator group were identified: 1) a retrospective case series of the Circulator Boot™ in patients with cholesterol embolization syndrome of the lower extremities who had not responded to previous therapies (Filip 2008), and 2) one small randomized clinical trial (RCT) of IPC for treatment of arterial insufficiency (Delis 2005).Evidence for the Circulator Boot™ is limited to a handful of observational studies primarily from one investigator group led by the physician (Dillon) who invented the technology. Additional citations listed on the corporation’s website provide weak, self-serving arguments for using observational data to address questions of effectiveness, rather than carrying out controlled studies and RCTs, in particular.Observational studies, such as case series or cross sectional studies, can be helpful in positing the presence of a causal relationship or in situations where RCTs would be impractical or unethical, but that is not the situation here. As with any study design, the validity of the results, and hence, the degree of certainty derived from them, will depend on the extent to which bias and confounders are minimized in the conduct of the study. Controlled studies comparing mechanical compression therapies for treatment of CVI would be needed to validate the presence and magnitude of a causal relationship, and the literature demonstrates that these types of studies have been conducted successfully.For now, the available evidence is insufficient to permit conclusions regarding the relative effectiveness of the Circulator Boot™ as a treatment option for CVI.Treatment of CVI and ulcers. Compression therapy has become standard treatment for CVI, despite lacking sufficient evidence regarding the optimal strategy. Compression therapy includes bandages, stockings, Unna boots and various IPC devices. Ambulation, limb elevation and anticoagulants (in high risk patients) may also be employed. Contraindications to using IPC include significant arterial insufficiency, edema from congestive heart failure, active phlebitis, DVT and the presence of localized wound infection or cellulitis (Berliner 2003).For treating venous leg ulcers, evidence suggests that using some form of external mechanical compression therapy is better than nothing, but the relative benefit of IPC versus other alternatives, particularly compression bandages, is unclear. Comparative study of the optimal use of compression therapy versus other options is insufficient. Limited evidence exists for using IPC in a subset of patients for the treatment of edema with significant ulceration of the lower limbs associated with CVI after other standard therapies have failed.Van Hecke (2008) synthesized guidelines for treatment of venous leg ulcers published since 1998 that included detailed, transparent, evidence-based methodology.8 There was consensus for supporting the use of: 1) graduated multilayer high compression systems for uncomplicated venous ulcer; 2) high compression over low compression, when correctly applied by a trained practitioner; and 3) correctly fitted compression hosiery for healed ulcers to prevent recurrence. There was no mention of the use of other compression devices.Analysis of each guideline development process revealed that existing guidelines varied with respect to stakeholder involvement and generally lacked information on patient compliance, quality of life, organizational aspects of care, and economic evaluation. Reasons for this may be the lack of a multidisciplinary approach to, and patient involvement in, the guideline development process, as well as the paucity of this information in the research literature. To better inform clinical practice, future research should incorporate these outcomes.Major US payers support the use of IPC for treatment of CVI of the lower extremities with one or more venous stasis ulcer(s), after six months of standard compression therapy has failed. RCTs are needed to address important questions regarding optimal administration, risks and benefits derived from different types of mechanical compression, as well as patient satisfaction, staff knowledge and skill, and available resources.Thromboprophylaxis. Evidence for the effectiveness of IPC alone, or in combination with anticoagulants, in reducing the risk of VTE consists of studies of high risk trauma and non-trauma populations. The evidence of whether to use IPC alone, or in combination, is conflicting. Limited evidence suggests IPC may reduce the incidence of DVT (but not PE) for patients with restricted ambulation due to trauma, joint surgery or neurosurgery. The evidence is inconclusive for the effectiveness of IPC for thromboprophylaxis in post-stroke care.One reason for the lack of clear guidance from the research literature on the effectiveness of IPC for thromboprophylaxis may be that much of the research conflates various high risk populations, or extrapolates results from studies of non-trauma patients to trauma patients.9 Trauma patients comprise a unique population whose physiologic response to injury should be taken into account when determining the optimal strategy for thromboprophylaxis, and in designing future research.Peripheral arterial disease. Limited promising evidence is emerging for the use of IPC for this indication, but at this stage it is far from conclusive. Again, RCTs are needed to clarify its role.

Project Status: Completed

URL for project: http://www4.va.gov/VATAP/docs/CirculatorBoot2010.pdf

Year Published: 2009

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: VA Technology Assessment Program

Contact Address: Liz Adams, VA Technology Assessment Program, Office of Patient Care Services (11T), VA Boston Healthcare System Room 4D-142, 150 South Huntington Avenue, Boston, MA 02130 USA Tel: +1 617 278 4469; Fax: +1 617 264 6587;

Contact Name: elizabeth.adams@med.va.gov

Contact Email: elizabeth.adams@med.va.gov

Copyright: VA Technology Assessment Program (VATAP)