Guidelines for the treatment of arterial insufficiency ulcers

An advisory panel of academicians, private practice physicians, nurse clinicians, and research nurses was chosen to develop guidelines (minimum standards) for the treatment of arterial insufficiency ulcers of the lower extremities. Previous guidelines, meta-analyses, PubMed, MEDLINE, EMBASE, The Cochrane Database of Systematic Reviews, recent review articles of arterial ulcer treatment, and the Medicare/CMS consensus of usual treatment of chronic wounds were all searched and reviewed for evidence. Guidelines were formulated, the underlying principle(s) enumerated, and evidence references listed and coded. The code abbreviations for the evidence citations were as follows: There were major differences between our approach to evidence citations and past approaches to evidence-based guidelines. Most past approaches relied only on publications regarding clinical human studies. Laboratory or animal studies were not cited. We have used well-controlled animal studies that present proof of principle, especially when a clinical series corroborated the laboratory results. It was also clear that principles that have been validated for other chronic wound types often are applicable to arterial ulcers. Therefore, evidence was sometimes cited that was not specific for arterial ulcers. Because of these variations, a different system was used to grade the evidence weight supporting a given guideline. The level strength of evidence supporting a guideline is listed as Levels I, II, or III. The guideline levels are: Level I: Meta-analysis of multiple RCTs or at least two RCTs support the intervention of the guideline. Another route would be multiple laboratory or animal experiments with at least two clinical series supporting the laboratory results. Level II: Less 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 not yet supported by adequate human experience is included. Level III: Suggestive data of proof-of-principle, but lacking sufficient data such as meta analysis, RCT, or multiple clinical series. N.B. The suggestion in the guideline can be positive or negative at the proposed level (e.g., meta-analysis and two RCTs stating intervention is not of use in treating arterial ulcers). In addition to Level of Evidence, the committee agreed to classify the strength of the recommendation. The purpose is to correlate Level of Evidence with Level of Strength. The Levels of Strength supporting a guideline are listed as Level A, Level B, Level C, or Level D. The guideline levels of strength are: Level A: Strongly recommended/Likely to be of benefit. Level B: Recommended. Level C: Recommended but not essential. Level D: NOT recommended. Guidelines have been formulated in seven categories for the treatment of arterial ulcers of the lower extremities. The categories are: Diagnosis Surgery Infection control Wound bed preparation Dressings Adjuvant therapy (device, systemic, local/topical) Long-term maintenance Each of the guidelines underwent a Delphi consensus among the panel members. Each set was critically evaluated by all panel members. There was a consensus of at least ten panel members on each individual guideline. The majority of the guidelines had unanimous concurrence. The resultant GUIDELINES FOR THE TREATMENT OF ARTERIAL INSUFFICIENCY ULCERS are attached. These are guidelines for treatment. They are intended to guide wound caretakers in choosing the best available options. They are NOT meant to be standards of care. Preamble: Peripheral arterial occlusive disease (PAOD) affects approximately 10 million people in the United States and is highly associated with significant morbidity and mortality. Because of its high prevalence and associated co-morbidities, there must be an effort to detect arterial disease in patients with wounds and to select appropriate therapy when arterial insufficiency is identified as a significant or primary etiology for an ulcer. [Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Peripheral arterial disease and treatment in the primary care. patients with lower ulcers be for arterial The and that arterial disease be of arterial disease in the of a with a lower ulcer to a The to a not been by clinical treating patients with lower ulcers these as appropriate for and in a is or and patients present with and NOT to be of to There can be The of a for of can be the is In is not present in in and are in in of in of when the to for of for and a of is for disease and for than of patients with to an not have but a in of for of the studies in the two the for is by a all patients with but for be and are in patients with or in other patients have and also to to a as is also of on the is not available in It is a that be in all patients with lower ulcers is of studies have that a of is associated with to arterial insufficiency in and of studies have at the of to of an The studies have all been in patients for and for have been These studies the between and when effort is to (e.g., would be to and the and a meta-analysis to the of to studies to There were a of lower in patients with and the was was as or of the They that was the for to with a of and a of The positive to of the was and the negative was The was is a of disease than or studies that is as studies that than studies and or The of to its for also been used to the of intervention or These data that be to in for and the of intervention. these studies that by a be for all patients with and be for patients with would be the would to arterial arterial ulcers are insufficiency to in ulcers with primary etiology such as or insufficiency and and treatment options. AT, Criqui MH, Treat-Jacobson D, Peripheral arterial disease and treatment in the primary care. 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Preamble: Wound bed preparation is as the of the wound to or to the of other The of wound bed preparation is to the and of a chronic wound to that of an The principles of wound bed preparation have been Wound bed a approach to wound Wound D, the wound and Wound An arterial ulcer is a of a of It is to the as a and the of of and and A: a in and of The of a major or disease and such as and with wound by in and such as or can all and or wound can in addition to a of the wound is of benefit. and guidelines for of wounds and of of and in wound of in wound in the major A, of and on and of and Surgery chronic a on and for B: must be adequate to sufficient to support the of weight must be for a chronic wound to I, of the of in critically a in the of D. and weight the of intervention in wound Wound The of in the of lower and A, wound and in Surgery weight and the of wound weight and the the of Wound wound a of wound C: in an that is to the wound be is and other that such as or all by these must be or of wound and in B, as an of the of and on in Wound and wound and can and in to wound in Wound the of wound in in wound and of and is the be only in a with and of an ulcer in the of adequate arterial an ulcer when for are not available and by and wound and of the often to of is to A, of and An of associated with Wound and its in the insufficiency and and treatment options. 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The Cochrane Database of Systematic The Cochrane a that is and appropriate to the ulcer etiology and the or often be chosen Because of are often as the least and when is to and of of and as as the of the Dressings and for arterial ulcers. Cochrane Database C, A, of in the treatment of a Wound The chronic and its in the of wound bed Preamble: The level of evidence for arterial ulcers is a to studies. arterial disease be be by when is or or when not in be Adjuvant therapy also be in in with research is to the use of therapy been in and ulcers. There are studies in arterial ulcers. for use in arterial ulcers be research be in have and on the and there are animal studies and series that support the of the of RCTs and the in that have been used in different studies to a for its in arterial ulcers. Systematic review of wound and MA, review of in wound negative and to be as an therapy in arterial on animal studies and series. of the and RCTs are to a recommendation. for wound a review of evidence in animal and clinical Systematic review of wound and MA, review of in wound negative and to be as an therapy in lower and on animal studies and series. It is in RCTs are to a recommendation. on one RCT that at two on patients with was not than in the of and the level of These and be as treatment of arterial RCTs that and use for each and on for the in a by a in and of in the of in patients with lower in the treatment of arterial occlusive negative wound therapy to be for ulcers. 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A: is to in of arterial in or was in when ulcers in patients with and and and in Most have been in patients with but ulcers to as In an RCT, a significant in in patients with significant with that was associated with a significant in levels in the treatment of studies have evaluated the of in the to wound with a significant when at is the best of B: The of in the treatment of in are I, therapy for chronic wounds The Cochrane of reviews I, Systematic review of in the of chronic MA, review of in wound negative and wound and in treatment. a approach to wound of the wound and with wound and an The use of in treatment of the D, wounds with negative wound Wound A, therapy in treatment of ulcer. a the of evidence for clinical practice guidelines. C, of chronic a as a of wound in and A, a and of wound by therapy in of on in of the of wounds with Wound therapy in chronic wound of the of of for a A, and Wound C, The of in lower ulcers with a of Wound not arterial ulcer The of in arterial ulcers to be a in clinical as with and for There are data use with ulcer of in of and and have not significant of in patients at of therapy in arterial occlusive on and therapy for arterial disease and There is evidence supporting the use of in the treatment of arterial ulcers. 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The chronic and its in the of wound bed of chronic wounds with of in patients with arterial occlusive disease and therapy with be of for arterial especially in patients with are not for studies are to its therapy with to the of the in and there are regarding the of there is a between the of for in different and studies with high of of I, A, of in patients with of Surgery therapy in patients with chronic in patients with and therapy been for wound is to its It been that is for wound and that wounds or in to evidence the of that in to Because is for wound is to the of in wound The of to is The of to an to be quite The best data to a of or the wound when is of the used to to the of for have been as a a or by a system a and an the or as a a or as a The of of the is of at the wound been to and wound in animal studies. of studies and clinical series a of in the treatment of a of ulcers. ulcers such as ulcers have the best of these clinical series arterial ulcers. the only to The used in the have been have been in a that of the would for the use of be for arterial ulcers studies. The literature often a on literature that the of in treating arterial insufficiency ulcers. literature not to the route of and of are different with the two and are use of the be to be but is to the two to of in to the wound high as The of that can be is by the of arterial or with high In is as the of than to a is the at of for for a of the evidence supporting the use of in arterial ulcers. as an to wound a clinical series. of for treatment of ulcers. wound in treatment with The of on lower in the treatment of a clinical and of therapy in a of Wound for ulcers. therapy treatment of and ulcers. Preamble: with arterial disease often be and yet present with significant The of to arterial disease with and of arterial with a of approximately Therefore, of the a significant in morbidity and Peripheral arterial and is the significant to be It control of and to these the of arterial ulcer and as as such as and Criqui MH, A, a of 10 in patients with Peripheral arterial and of the Peripheral arterial and in arterial with the and AT, Criqui MH, Treat-Jacobson D, Peripheral arterial disease and treatment in the primary care. insufficiency and and treatment options. therapy be and of arterial insufficiency and studies are A: as that is than and and with positive the other the in the primary of and in patients to and B: a in the of high the and and in treatment of arterial occlusive disease and of in patients at of therapy in arterial occlusive on and of treatment for of of on of chronic ulcers in patients with arterial occlusive a of in the for and and to arterial been to be in maintenance and arterial ulcer therapy is one of the for patients with It also in and Peripheral arterial and of the Peripheral arterial and insufficiency and and treatment options. in arterial with the and Criqui MH, A, a of 10 in patients with AT, Criqui MH, Treat-Jacobson D, Peripheral arterial disease and treatment in the primary care. was supported by the Wound a to the Wound