Guidelines for the prevention of lower extremity arterial ulcers

Abstract

The Wound Healing Society (WHS) is a professional society of physicians, nurses, physical therapists, podiatrists, and other wound care specialists, basic scientists, clinical researchers, and industrial researchers dedicated to assuring that every patient receives optimal wound care. Its mission is to advance the science and practice of wound healing. To that end, the following comprehensive, evidence- and consensus-based guidelines were developed to address the Prevention of Lower Extremity Arterial Insufficiency Ulcers. The guidelines are presented in generic terms; the details of specific tests, therapies, and procedures are at the discretion of an interdisciplinary team of health care professionals who establish, implement, and evaluate policies and procedures directed at prevention of arterial ulcers. As with the arterial ulcers treatment guidelines published in 2006,1 PubMed, EMBASE, CINAHL, and the Cochrane Database of Systematic Reviews were searched and reviewed for evidence on arterial insufficiency ulcer prevention. In addition, a search of health care databases for current evidence-based guidelines addressing the prevention of arterial insufficiency ulcers was conducted using electronic and online resources. The panel classified studies based on whether the intervention being evaluated addressed arterial ulcer risk screening and assessment, arterial ulcer prevention plans of care (including interdisciplinary approaches), or patient and caregiver education. Evidence references for each standard are listed and coded. The code abbreviations for the evidence citations were as follows: The strength of evidence supporting a guideline is listed as Level I, Level II, or Level III, using the following definitions: Level I: Meta-analysis of multiple RCTs or at least two RCTs supporting the intervention in the guideline or multiple laboratory or animal experiments with at least two clinical series supporting the laboratory results. Level II: Less evidence than Level I, but at least one RCT and at least two significant clinical series or expert opinion papers with literature reviews supporting the intervention. Experimental evidence that is quite convincing but without support by adequate human experience. Level III: Suggestive data of proof-of-principle, but lacking sufficient data such as meta-analysis, RCT or multiple clinical series. Hopf HW, Ueno C, Aslam R, Burnand K, Fife C, Grant L, Holloway A, Iafrati MD, Mani R, Misare B, Rosen N, Shapshak D, Slade JB, West J, Barbul A. Guidelines for the treatment of arterial insufficiency ulcers. Wound Rep Reg 2006; 14: 693–710 [STAT]. Guidelines have been formulated in four categories for the prevention of arterial ulcers of the lower extremities. Awareness and Education, Screening, Selection of Preventive Interventions: Medical, and Selection of Preventive Interventions: Surgical (including endovascular). Each of the guidelines underwent a DELPHI consensus among the panel members. Each set was critically evaluated by all panel members. There was a unanimous concurrence of all panel members on each individual guideline. The resultant “Guidelines for the Prevention of Arterial Insufficiency Ulcers” is attached. These guidelines are intended to guide wound caretakers in choosing the best available options. They are not meant to be standards of care. Preamble: Guidelines for the treatment of arterial insufficiency ulcers were published in the November–December 2006 issue of Wound Repair and Regeneration1 and are available online at no cost at http://www.woundheal.org. The current guidelines will focus on preventing lower extremity arterial insufficiency ulcers in adults with lower extremity peripheral arterial occlusive disease (PAOD), as well as preventing recurrence in those who have already had an arterial insufficiency ulcer. Clearly, the ideal way to prevent arterial ulcers is to prevent PAOD. Several outstanding consensus guidelines on prevention and management of cardiovascular disease, including PAOD, have been published recently,2,3,4 and therefore we will not focus on this issue. Rather, we will focus on measures to prevent lower extremity ulcers in patients who already have PAOD. PAOD has a high prevalence, especially among people older than 60 years (about 30–40%) and is associated with high risk of fatal and nonfatal cardiovascular events. Patients with PAOD may develop gangrene and spontaneous ulceration (critical limb ischemia) or impaired or failed healing of injury. Although patients with PAOD are at risk for amputation, their risk of death from cardiac causes is much higher. Criqui et al.5 demonstrated a 30% 5-year mortality (23% of vascular etiology, including 20% cardiovascular or cerebrovascular) in patients with PAOD, but only a 2% rate of amputation. Although 5-year survival is diminished in patients with critical limb ischemia (45% vs. 90% in age-matched controls), 5-year survival is also diminished in patients with claudication (75%).2 PAOD is a clear risk factor for cardiovascular mortality. All patients with PAOD should be evaluated for medical treatment with antiplatelet drugs, β blockers, statin therapy, and ACE inhibitors to reduce the risk of cardiovascular morbidity and mortality. Despite the high risk of death from cardiac causes in patients with PAOD, several studies have demonstrated that health care providers often underestimate the risks and provide less comprehensive cardiovascular treatment in patients with a presenting diagnosis of PAOD. In the ATTEST study,6 only 13% of patients with PAOD received appropriate cardiac risk reduction medical treatment compared with 30% of patients with coronary artery disease (CAD) or ischemic stroke. Thus, awareness of the implications of PAOD is critical to appropriate treatment of patients with PAOD, outside of the prevention of ulceration. Awareness of risk factors for PAOD will clearly increase recognition of it and thus initiation of appropriate treatment both to reduce mortality and to reduce the incidence of arterial ulcers. Risk factors include smoking, diabetes, age, gender, hyperlipidemia, renal insufficiency or failure, hyperviscosity or hypercoagulable states, nonambulatory status, CAD, cerebrovascular disease, race, level of awareness, hypertension, and associated vasculitis.2 Individuals at high risk for PAOD or other cardiovascular disease should be screened and assessed so that efforts can be focused with interdisciplinary plans of care for preventing peripheral arterial ulcers. Hopf HW, Ueno C, Aslam R, Burnand K, Fife C, Grant L, Holloway A, Iafrati MD, Mani R, Misare B, Rosen N, Shapshak D, Slade JB, West J, Barbul A. Guidelines for the treatment of arterial insufficiency ulcers. Wound Rep Reg 2006; 14: 693–710 [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA. Fowkes FGR on behalf of the TASC II working group. [STAT]. JB, D, J, guidelines for the management of patients with peripheral arterial disease and 2006; [STAT]. A, A. for of a peripheral arterial disease awareness an to cardiovascular [STAT]. Criqui A, MR, a of years in patients with peripheral arterial J, J, arterial disease other of vascular the ATTEST 2006; arterial [STAT]. Arterial Awareness PAOD is a of claudication is often of as the of PAOD, but only of patients with PAOD with this a of patients with claudication to arterial ulceration. patients with critical limb ischemia had PAOD the of or arterial ulcers in of PAOD with associated high of cardiovascular limb amputation, of and cost of health care. compared with other in the of cardiovascular PAOD is and is associated with and risks of cardiovascular events. Awareness and recognition of PAOD by care providers has a significant on prevention of ischemic arterial ulcers. include the for lower extremity and assessment, and to should have a high of for the of PAOD in patients with multiple risk not have disease Patients with PAOD may not to have of and may not develop in patients with peripheral of ischemia may not be among other such as or or cardiac high of is to disease, using such as on the or and Level of K, Criqui C, L, L, D, in peripheral arterial and Arterial insufficiency and and treatment options. Criqui D, Hiatt arterial disease awareness, and treatment in the care. arterial and [STAT]. J, J, arterial disease other of vascular the ATTEST 2006; Criqui A, A. and peripheral arterial the J, JA, D, arterial disease in of with in with coronary the and and a critical in prevention and treatment of arterial of 14: Arterial insufficiency and Wound WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. Awareness and recognition of the risks and of treatment of PAOD on cardiovascular in the PAOD should be in and Level of R, K, risk and medical treatment of patients with Arterial in an vascular MR, in Arterial the on and [STAT]. in cerebrovascular disease, coronary artery disease and peripheral arterial [STAT]. Hiatt medical for patients with Arterial a critical [STAT]. Risk medical and in limb from the Criqui A, MR, a of years in patients with peripheral artery Hiatt medical for patients with peripheral arterial a critical medical management of peripheral arterial 2006; should be and the of should or and at Patients may not of PAOD to health care providers and treatment health care Level of J, J, arterial disease other of vascular the ATTEST 2006; Criqui D, Hiatt arterial disease awareness and treatment in care. WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. of including have been at awareness of and cerebrovascular efforts at awareness of PAOD have been These should be and There is a with PAOD and associated and that is with physical to with of PAOD, such as Patients may also have with to and patients may have a and not be of the implications of this or the to medical Level of Criqui D, Hiatt arterial disease awareness and treatment in care. Dormandy J, B, L, of for ischemia and the of on healing. group. Dormandy JA, B, L, J, K, A, L, A, A, J, prevention of in patients with in the In a Dormandy J, I, Fowkes Norgren L, clinical to the management of a patient with disease who with treatment of 2006; [STAT]. Arterial Risk on ischemic arterial ulcers as an are PAOD is associated with other and this it is to patients with limb ulcers to PAOD. efforts should be to prevent ulcers in two those with PAOD who have to be and those who are already as PAOD. interdisciplinary team of appropriate health care including a practice or care physical and other health care professionals as should be to establish, and policies and procedures for the prevention of peripheral arterial ulcers. team is to the of that have been to be of working with patients who have been as PAOD, it is to of to critical limb ischemia and to a patient with PAOD to an management the of ulceration. Patients with an an or a less that are at high risk of arterial ulceration. to a vascular is Level of are lacking to of but and a for to a vascular Level of In patients with PAOD or should be assessed by The by is the is to is not The may be especially artery is as is in of this a of in or in is a significant and may also be of in following of should have a high of for of disease, and a for or for for vascular Level of L, Risk and occlusive peripheral arterial of of [STAT]. Criqui K, L, C, L, C, strength in peripheral arterial with disease and lower extremity Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. A. the clinical lower extremity peripheral arterial 2006; [STAT]. ischemia for in patients with ulceration. Criqui A. Risk factors for of peripheral artery disease in and 2006; Hiatt WR, arterial medical care and prevention of R, K, risk and medical treatment of patients with peripheral arterial disease in an vascular WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for guidelines for the management of patients with peripheral arterial disease and of a from the for for Society for and Society for and Society of and the on practice guidelines to develop guidelines for the management of patients with Arterial by the of and and Society for and 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. limb a of critical limb of patients who of one extremity for arterial ulceration will to arterial ulceration of the other These patients should be by a vascular Level of of the As with diagnosis is to preventing ulcers in patients with PAOD. care providers should be in risk factors and screening for PAOD. Patients should be to a vascular Level of should be in patients at high risk for vascular disease so as to patients with PAOD, as of the care physical Level of will of prevention with for vascular risk years have a 30% of coronary artery disease or cerebrovascular disease renal L, Risk and occlusive peripheral arterial of of [STAT]. Criqui K, L, C, L, C, strength in peripheral arterial with disease and lower extremity Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. A. the clinical lower extremity peripheral arterial 2006; [STAT]. B, of with arterial insufficiency and ulceration without 2006; Criqui A. Risk factors for of peripheral artery disease in and 2006; of the peripheral of PAOD develop at the or level and may to ulceration not These of or or and with a or should be with a or other in the to a limb often from in patients without PAOD. Level of Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. Criqui A, MR, The of peripheral artery disease in a of and risk factors for peripheral arterial disease in the from the and Fowkes artery of and peripheral arterial disease in the WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for guidelines for the management of patients with peripheral arterial disease and of a from the for for Society for and Society for and Society of and the on practice guidelines to develop guidelines for the management of patients with Arterial by the of and and Society for and 2006; [STAT]. WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. Selection of Preventive Interventions: Prevention of ischemic arterial ulcers should focus on management of PAOD and prevention of to the and of patients at should be and with a evidence-based treatment guidelines for medical (including β blockers, ACE and will for not only coronary artery disease, but also ischemic arterial ulcers. Level of Hiatt WR, arterial medical care and prevention of Hiatt for peripheral arterial disease and Criqui D, Hiatt arterial disease awareness and treatment in care. Dormandy J, B, L, of for ischemia and the of on healing. group. Dormandy JA, B, L, J, K, A, L, A, A, J, prevention of in patients with in the In a Dormandy J, I, Fowkes Norgren L, clinical to the management of a patient with disease who with treatment of 2006; [STAT]. management of occlusive arterial disease of the extremities. Lower extremity arterial and ulcers. vascular diagnosis and 2006; of is by the factor the of peripheral disease to arterial ulceration. to patients with PAOD to should be of years of is associated with risk of vascular and mortality. therapy, and should be with to Level of JA, risk reduction associated with in patients with coronary a JA, and the of lower limb extremity a [STAT]. J, The of a intervention on a clinical health and medical management of peripheral arterial 2006; WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. at a a to and the to claudication as well as peripheral and of PAOD is by of of ischemic and of in of a comprehensive of patient and The of in preventing or arterial ulcers has not been clearly may increase the risk of and ulceration. a is Level of Hiatt R, of strength for patients with peripheral arterial for the of A, for the treatment of claudication a [STAT]. K, Hiatt J, A. for Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. medical management of peripheral arterial 2006; WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. the rate of of peripheral disease and the for intervention. or is also to reduce the risk of and vascular death in patients with PAOD. Level of in and have been as a factor for in PAOD. of antiplatelet the incidence of cardiovascular In the in Patients at Risk for the incidence of cardiovascular death by in patients to and in patients to The published than patients to with or without the of The failed to a in of from or cardiovascular death including the treatment in the vs. in the to guidelines for the prevention of arterial risks with no clinical in people with the antiplatelet as prevention based on the of multiple risk factors without cardiovascular the other in the with cardiovascular disease, was a significant clinical of antiplatelet a increase in These data support a for antiplatelet in all patients at risk for PAOD, it is whether compared with In of PAOD, antiplatelet may be the specific are not of in patients at risk of ischemic MD, J, of in the for Risk and and D, R, A, A. in a 2006; 14: MD, C, Risk cardiac management vascular of therapy, clinical and to cardiac management vascular JB, JA, of guideline for cardiovascular for a of the of on Guidelines to the guidelines on cardiovascular for [STAT]. WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. of ischemic arterial ulcer are the of their of is not Level of of Arterial treatment of peripheral arterial 2006; A. the clinical lower extremity peripheral arterial 2006; Hiatt WR, of on the of peripheral arterial Hiatt treatment of peripheral arterial disease and B, A, J, A, of in people at of vascular disease of a clinical in medical management of peripheral arterial 2006; WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. of and management of using guidelines should be including of is associated with prevention of PAOD ischemic ulcers the risk of PAOD to and can in and and the appropriate are in in the and Prevention Guidelines for ulcers in this issue. Level of with or compared with treatment and risk and in patients with The and of management on and risk factors in the and [STAT]. WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. were not to treatment of and PAOD. Level of J, J, C, Prevention with and in vascular 2006; I, A, and cardiovascular 2006; WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. Lower extremity should be in patients with or PAOD whether or not the patient has associated from or other The for is lower than for The limb may be but may be in patients with PAOD. Level of with and are to prevention of ulceration by Prevention of is to limb Level of is as Patients should be on to prevent to the lower Level of of and in or patients with for or should be In patients with PAOD, of a ulcer to amputation. Level of In patients with should be to with and of to the in PAOD especially associated with and disease, the risk of and may recognition of the risk of amputation. Level of Patients with PAOD, is a should in their In care for patients with PAOD should be by a or other the is or is significant Level of consensus on and the from the consensus on diagnosis and the [STAT]. R, of the in a J, R, as an risk factor for in critical limb N, D, ulcers in patients with C, K, C, of on in patients with a of ulcer using available clinical 2006; of risk factors for ulcer. D, patients at risk for ulceration. in L, B, K, K, J, JA, J, C, of risk factors to in patients on ulcer and arterial Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. of care in a on wound care. N, ulcers in patients with has been to arterial in ischemic and may be of in or preventing arterial ulcers. Level of The for of the lower extremity as a treatment in arterial N, C, for the treatment of lower extremity arterial a [STAT]. The of on the arterial and of the lower a in the treatment of peripheral arterial occlusive disease or 2006 and of arterial with an the N, A, of in patients with critical limb D, treatment for R, J, A, J, The in lower limb of the as with a has been to in ischemic and is to be of in preventing or arterial ulcers. Level of The of on in and ischemic lower extremities. A, B, C, the of ischemic limb ulceration. insufficiency with PAOD and is the treatment for insufficiency and should be to the The ideal of adequate in patients with PAOD without or ulceration or the risk of or has not been is a of for prevention of arterial ulcers. Level of N, for ulcers and on healing. J, is and Wound of in in patients with lower peripheral and of and arterial Wound All ulcers are not preventing arterial ulcers. patients with or is associated with an risk of an ischemic arterial ulcer and should be addressed by a care Level of MR, of of the Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. A, for the treatment of claudication a [STAT]. Hiatt R, of vs. strength for patients with peripheral arterial for the of Criqui D, Hiatt arterial disease awareness, and treatment in the care. of and risk factors for peripheral arterial disease in the from the and [STAT]. of lower limb [STAT]. Nehler MR, Hiatt WR, in a series of lower extremity R, B, The of intervention on of in patients with of lower limb in the of patients with peripheral vascular of for critical limb an of vascular 2006; Selection of Preventive Interventions: Surgical There is no for lower extremity or to prevent the of PAOD to arterial ulceration. claudication to for claudication should be to patients with a significant The of is a clear for to prevent limb Level of the is no for in patients without it is for the to patients in the of management of PAOD ulceration or will the may be The and in procedures may be the a provide data for the appropriate treatment in a to a vascular for is critical to the of In all whether is or the intervention. B, of with arterial insufficiency and ulceration without 2006; A, of ischemic ulceration and an of factors associated with healing. N, of a of an of Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. Hopf HW, Ueno C, Aslam R, Burnand K, Fife C, Grant L, Holloway A, Iafrati MD, Mani R, Misare B, Rosen N, Shapshak D, Slade JB, West J, Barbul A. Guidelines for the treatment of arterial insufficiency ulcers. Wound Rep Reg 2006; 14: 693–710 [STAT]. of should be should be with peripheral artery or has been to the of artery Level of that are less well but may have a include such as and and statin of evidence for are The the of an to at the of and that was no in of or MD, J, of in the for Risk and and L, C, C, R, N, and of and in the prevention of occlusive vascular a and [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT]. J, for preventing peripheral arterial Cochrane Database J, A, Systematic of of and in prevention of and ischemic [STAT]. J, for preventing peripheral Cochrane Database [STAT]. Risk medical and in limb from the R, K, risk and medical treatment of patients with Arterial in an vascular MR, in Arterial the on and [STAT]. J, is associated with of L, C, J, N, B, A, B, A, L, B, of of treatment for lower limb and mortality associated with of to patients with peripheral arterial a L, of III: a of for the prevention of in lower extremity 2006; WR, JB, D, J, R, for Society for Society for and Society for and Society of on of and and Society for Guidelines for the management of patients with peripheral arterial 2006; [STAT]. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris Fowkes FGR on behalf of the TASC II working group. [STAT].