Guidelines for the treatment of venous ulcers

Abstract

An advisory panel of academicians, private practice physicians, podiatrists, nurse clinicians, research nurses, industrial scientists, and an epidemiologist was chosen to develop guidelines for the treatment of venous ulcers of the lower extremity. Previous guidelines, meta-analyses, PubMed, MEDLINE, EMBASE, The Cochrane Database of Systematic Reviews, recent review articles of venous ulcer treatment, and the Medicare/CMS consensus of usual treatment of chronic wounds were all 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 venous ulcers. Therefore, evidence was sometimes cited that was not specific for venous 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 Level I, Level II, or Level 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. NB: 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 venous ulcers). Guidelines have been formulated in eight categories for the treatment of venous ulcers of the lower extremities. The categories are: Diagnosis Compression Infection Control Wound Bed Preparation Dressings Surgery Adjuvant Agents (Topical, Device, Systemic) Long-Term Maintenance Each of the separate guidelines underwent a Delphi consensus among the panel members to be critically evaluated. There was a consensus of at least ten panel members on each individual guideline. The majority of the guidelines had unanimous concurrence. The draft guidelines were presented at an open conference on October 3, 2005. Following the conference and audience discussion, a period of one month was allowed for written comments and submission of additional evidence literature. The draft guidelines were then modified, taking into consideration all verbal and written comments. The resultant Guidelines for the Treatment of Venous Ulcers follows. Preamble: Ulcers of the lower extremity may be caused by a variety of conditions. Elevation of ambulatory venous pressure (venous hypertension) is the most common. However, as treatment of the ulcer may vary depending on ulcer etiology, it is paramount that a correct diagnosis is made before treatment. Guideline #1.1: Gross arterial disease should be ruled out by establishing that pedal pulses are present on physical examination and/or that the ankle : brachial index (ABI) is >0.8. (Any ABI less than 1.0 suggests a degree of vascular disease and compression therapy is usually considered to be contraindicated with an ABI<0.7.) In elderly patients, patients with diabetes mellitus, or patients with an ABI>1.2, a toe : brachial index of >0.6 or a trans-cutaneous oxygen partial pressure of >30 mmHg in the region of the ulcer may help to suggest an adequate arterial flow (Level I). Principle: Venous ulcers can exist in the presence of mixed arterial/venous pathology. However, treatment of only the elevated venous pressure will not succeed when significant arterial disease is present. Evidence: Porter JM, Moneta GL. International consensus committee on chronic venous disease: reporting standards in venous disease: an update. J Vasc Surg 1995; 21: 635–45 [STAT]. Beebe HG, Bergan JJ, Bergqvist D et al. Classification and grading of chronic venous disease in the lower limbs: a consensus statement. Eur J Vasc Endovasc Surg 1996; 12: 487–92 [STAT]. Beebe HG, Bergan JJ, Bergqvist D et al. Classification and grading of chronic venous disease in the lower limbs: a consensus statement. Internat Angiology 1995; 14: 197–201 [STAT]. Porter JM, Rutherford RB, Clagett GP et al. Reporting standards in venous disease. J Vasc Surg 1988; 8: 172–81 [STAT]. Kjaer ML, Mainz J, Soerensen LT et al. Clinical quality indicators of venous leg ulcers: development, feasibility, and reliability. Ostomy/Wound [STAT]. et al. Venous ulcers: and treatment Ostomy/Wound J, et al. of chronic venous ulcers is not by the of to J D et al. arterial disease and treatment in Guideline have been used to venous leg ulcers clinical and and It is to the diagnosis was made and to the of the with compression or a is in and data to a venous for the leg ulcer (Level I). Principle: clinical and physical examination can be of a venous of the lower extremity ulcer arterial been a diagnosis of the venous disease is is not to venous it is paramount that the by the be to the Evidence: Porter JM, Moneta GL. International consensus committee on chronic venous disease. Reporting standards on venous disease: an update. J Vasc Surg 1995; [STAT]. Beebe HG, Bergan JJ, Bergqvist D et al. Classification and grading of chronic venous disease in the lower limbs: a consensus statement. Eur J Vasc Endovasc Surg 1996; 12: 487–92 [STAT]. Beebe HG, Bergan JJ, Bergqvist D et al. Classification and grading of chronic venous disease in the lower limbs: a consensus statement. 1995; 14: 197–201 [STAT]. Porter JM, Rutherford RB, Clagett GP et al. Reporting standards in venous disease. J Vasc Surg 1988; 8: 172–81 [STAT]. Kjaer ML, Mainz J, Soerensen LT et al. Clinical quality indicators of venous leg ulcers: development, feasibility, and reliability. Ostomy/Wound [STAT]. et al. and treatment of leg J Guideline with an venous ulcer and are of disease should have a and a (Level Principle: with or can present with lower extremity ulcers venous ulcers. Evidence: et al. in patients and review of the literature. J in Surg Guideline venous ulcers that have been open of for or that not to treatment should be for diagnosis (Level Principle: and of may present as ulcers on the lower extremity. Evidence: on the and at a leg ulcer that as venous ulcer disease. Ostomy/Wound et al. and treatment of leg J ulcers of J 21: Guideline venous as as all that are and that in and/or treatment should be considered for other such as chronic and or should be especially the ulcer is in or the a disease such as vascular or (Level Principle: ulcers that in and treatment, or not of treatment, should that the ulcer is not venous in or that the therapy to be specific for and/or are as for Evidence: J, et al. Treatment for an evidence-based review of the literature on than J [STAT]. et al. and of J a of J a [STAT]. ML, JM, et al. of and with an on to review of patients Preamble: Venous an elevated ambulatory venous pressure (venous of the compression been the to these Guideline The use of a system is in the treatment of venous ulcers. these are in can in and The degree of compression be when mixed disease is the (Level I). Principle: Venous ulcer is when adequate compression is to the lower extremity. Evidence: Compression for venous leg ulcers. The Cochrane Database of Systematic The Cochrane and and Treatment of leg ulcers. of venous ulcers. Ostomy/Wound J, et al. of chronic venous ulcers is not by the of to J et al. of and of two of compression in treating venous ulcers. Vasc Surg Guideline pressure can be used with or compression and can in patients or will not use an adequate compression system (Level I). Principle: pressure venous and can be when compression is not Evidence: J et al. compression venous ulcer a Surgery compression in the treatment of venous leg ulcers. J Surg and and Because venous is an a degree of compression therapy should be and Long-Term Maintenance Preamble: Infection when the : is in of the Infection in the etiology, and of venous ulcers. Guideline all or by or (Level I). of is in Wound Preparation Principle: is with the to and as a for Evidence: et al. in wound In of Wound in The of chronic a [STAT]. et al. of and on the of ulcers. J Surg 1996; of ulcers: and Wound and the of a for multiple of 14: et al. of wound Surg index and with of ulcers. Wound et al. for chronic venous ulcers. J 14: Guideline is in a or the is not of and of compression the and level of in the ulcer by or by a validated (Level Principle: levels of of or level of the and have been to and of venous ulcers. should be to and Evidence: Wound caused by Surg Wound a of wound caused by an of Surg of chronic leg ulcers. of and Surg on a in the of the RB, et al. The and a for the of in open J The et al. wound a J Surg [STAT]. et al. the of chronic wounds wound in J The of in chronic leg ulcers. Surg Guideline ulcers with of or level of adequate the level with in the use of the to to the or of to the (Level I). Principle: not levels in can be Evidence: Wound a of wound caused by an of Surg et al. of two wound for the treatment of venous ulcers. J Vasc Surg of chronic leg ulcers. I, et al. The of in leg ulcer by a a et al. Maintenance of wound J Surg The of in chronic leg ulcers. Surg et al. The of on venous ulcer J Wound and the of J et al. and of venous leg ulcers. 1996; et al. of to venous J Guideline and of the and most to or the venous ulcer should be with (Level Principle: the of and the of the and to by and Evidence: et al. with to the of the an update. J Agents and of the J Treatment of and et al. of the J et al. of in patients with and Guideline the level of to of with in the venous ulcer before by or (Level Principle: wound with than of be as the of wound that is Evidence: et al. of Surg The of on the of in Surg and Surg et al. The of on and J Surg of and Surg in patients with ulcers wound of Ostomy/Wound of wound are out of are of and are in Infection Control Dressings and Adjuvant Agents Device, and Preamble: Wound is as the of the wound to or to the of other The of wound is to the and of a chronic wound to that of an The principles of wound have been et al. Wound a approach to wound Wound the wound and Ostomy/Wound Guideline of the as a is to and correct of such and and and (Level Principle: and physical a will help in and of The presence of a major or disease and such as and will with wound by in and such as or can all and may or before wound can major have a as chronic in to a of the wound is of Evidence: et al. and guidelines for of wounds and of [STAT]. of and in wound of in wound in the et al. major J Surg 1996; et al. of and on and of and Surgery chronic a on and for J Surg Principle: be adequate to sufficient to support the of most venous ulcer patients are ambulatory and not as as patients or chronic support is an individual is Evidence: I, et al. of the of in critically a consideration in the of J and weight the of intervention in wound Ostomy/Wound Principle: will in an that is to a wound will be is and that such as or will all oxygen by these be or Evidence: et al. of wound and oxygen in Surg as an a of the of oxygen and on in Surg Wound and wound and can Surg et al. and in to wound in Surg et al. Surg et al. Wound oxygen the of wound in Surg in wound and J Surg Guideline is to the and of and Maintenance is to the and of the wound for The can a of or than one may be (Level I). Principle: and can all wound is often the most However, the of chosen may on the of the the of the the of the and can in a of the with a of Evidence: J Surg the Wound and Wound The of chronic a [STAT]. the wound and Ostomy/Wound J, et al. of of a Wound 12: index and with of ulcers. Wound et al. for chronic venous leg ulcers. J 14: et al. of on the of ulcers. J Surg 1996; therapy is a treatment of venous leg ulcers. J Wound and the of a for multiple of the 14: et al. of and for pressure ulcer 14: in the treatment of and ulcers. J et al. the of and a treatment in venous leg ulcers. for Ostomy/Wound 1995; The and of two wound J The of on and in J Surg of two in the of venous ulcers. Ostomy/Wound of and compression for the treatment of venous leg ulcers. Guideline should be and at each a wound should be with a of and/or (Level Principle: and the wound to wound or is usually should only be used the is Experimental data suggest that a may be as may by Evidence: Wound wound wound Wound Clinical for clinical experience with in vascular wound J Wound 21: et al. a wound et al. of wound Surg Guideline There should be an and of wound and of the and to wound The of wound should be to treatment is (Level I). Principle: of wound are the ulcer is not at the for wound to be The the of the the it is to an ulcer is or of and to be Evidence: et al. and guidelines for of wounds and of [STAT]. index and with of ulcers. Wound Wound a Wound Porter JM, Moneta International on Venous Reporting standards on venous disease: an update. J Vasc 1995; 21: 635–45 [STAT]. Beebe HG, Bergan JJ, Bergqvist D et al. Classification and grading of chronic venous disease in the lower limbs: a consensus statement. Eur J Vasc Endovasc Surg 1996; 12: 487–92 [STAT]. of the to venous ulcer Ostomy/Wound J, of in venous leg ulcer as a index of at J [STAT]. leg ulcers: and of J Preamble: There is a of for treatment of venous ulcers. wound and/or with Guidelines are to help the regarding the and use of these wound Most will be used in with compression Compression Guideline a that will a (Level I). Principle: wound and of wounds by wound also are considered and can of the Evidence: of and on the of a et al. of partial wounds in a J Surg et al. of wounds in a Surg JJ, J, et al. wound Surg of chronic venous ulcers: a 12: et al. The of on venous ulcer Eur J Vasc Endovasc Surg or for in venous leg ulcers. The Cochrane Database of Systematic The Cochrane [STAT]. out to and of venous and pressure ulcer of [STAT]. of leg ulcers with Guideline clinical to a wound that (Level I). Principle: are not considered are as as other types of wound in of may have other such as of the of and It can also be to Evidence: of in the treatment of leg ulcers: a Wound The of two on wound J Surg 8: et al. Clinical of J Surg et al. venous ulcers. Vasc Surg 8: J, of J Wound 1996; et al. Systematic reviews of wound Dressings and used in the of chronic [STAT]. D et al. of for the treatment of venous ulcers. J out to Guideline a that will the wound and the (Level I). Principle: and with wound can the wound and Evidence: of by chronic wound Wound et al. of the and chronic wound the of and Wound et al. Wound human pressure ulcers elevated levels and to wound J 1996; et al. of of in venous ulcers. Wound J, of J Wound 1996; of two in the of venous ulcers. Ostomy/Wound The of in the treatment of venous leg ulcers with and J in chronic venous wound Guideline a that in and and not additional (Level Principle: Wound and can all the of The use of compression for venous ulcers the for to the in However, additional may the pressure on the wound or Venous ulcer patients are to to Evidence: J 8: et al. of patients with or leg ulcers: of the and the and of the of positive to of in and leg et al. in leg ulcer 1988; and venous Wound in chronic venous wound Guideline a that is and to the and the (Level I). Principle: Because of are often as the least most However, as out in Guideline it is to a it is to into consideration of and as as the of the Evidence: et al. of leg ulcer treatment in J 12: et al. and of and in the of patients with chronic leg et al. An of for the treatment of venous leg ulcers. Wound 8: a to a in the of venous leg ulcers: a clinical Ostomy/Wound out to et al. and of venous and pressure ulcer of [STAT]. Guideline use and/or individual and when is a of in to of these are in Adjuvant Agents Device, Level Principle: and may and in patients or are quite and are in in the Adjuvant Agents Evidence: references are in the Adjuvant Agents (Topical, Device, Systemic) Preamble: The of wound and a compression system are not in all venous ulcers. not the of ambulatory venous the multiple have been to venous ulcers with of clinical are in the but data are supporting in data a Venous a to treatment. J Vasc Surg 1996; Guideline of a venous to the underlying venous is not a and is to leg (Level I). Principle: the venous ulcer with an may a of wound but not the ambulatory venous pressure (venous hypertension) that is the underlying of the Evidence: for venous ulcers. The Cochrane Database of Systematic The Cochrane [STAT]. Treatment of leg ulcers with and results. J Surg et al. or in venous ulcers: a J et al. of leg ulcers. Surg 1995; 21: Guideline is the of when it is to the underlying venous of the ulcer by the to the venous the when be to all The is not the venous disease with or The with or or use of a a lower and with the open in of ulcer and (Level I). Principle: of will in elevated ambulatory venous pressure in the Evidence: et al. open of in the treatment of venous leg a J Vasc Surg et al. with or treatment for leg ulcers. Bergan JJ, et al. of for chronic venous the The J Vasc Surg [STAT]. et al. open of in the treatment of venous leg J Vasc Surg treatment of venous ulcers: of Surg et al. for patients with chronic venous Vasc Endovasc Surg et al. Treatment of and venous is J Vasc Surg Guideline Less on the venous system such as venous or especially when with compression can be in the of venous ulcers (Level I). Principle: that are less than of multiple can help to venous when with an adequate compression Evidence: J et al. of and compression with compression in chronic venous et al. clinical of compression compression in chronic venous and J Surg et al. of venous ulcers compression a clinical Eur J Vasc Endovasc Surg of venous a J Vasc Surg [STAT]. of in patients and Vasc Surg Guideline with can venous ulcers with by of and venous in the (Level Principle: a region of the can with to an of Evidence: et al. for venous J Vasc Surg treatment for venous ulcers. J Vasc Surg et al. and clinical of for treatment of venous in the lower extremity. in treatment of the chronic venous Surg with in the treatment of chronic venous ulcers. J Preamble: have been for use as to and compression therapy in the treatment of venous ulcers. can be into to be to the at ulcer and to the of these have evidence to guidelines regarding use to be Guideline have yet to be to sufficient significant of to of for treatment of venous suggest (Level I). Principle: are of the have been to be or in chronic be for treatment of venous and have positive in series. Evidence: et al. of in venous ulcer Eur J Vasc Endovasc Surg et al. and with 1995; et al. of in the treatment of venous ulcers of the J, et al. of in patients with chronic venous ulcers. Wound human in and of chronic venous ulcers. J et al. use of human in venous ulcers. J Surg et al. The and of for treatment of venous ulcers. Wound 1995; et al. of to in venous ulcers. Wound J, et al. of chronic venous ulcers is not by the of to J J et al. of levels of in wounds with and of in chronic 1995; et al. of in chronic Surg The of venous ulcers. 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Evidence: J et al. with in chronic venous ulcers. J Treatment of venous leg ulcers with a open J Treatment of leg ulcers with Clinical and Ostomy/Wound 1995; et al. Treatment of chronic venous ulcers with of J Guideline may be in the of venous leg ulcers (Level I). Principle: of have been to wound in data exist to the should be or and or is Evidence: of for of venous et al. of on chronic leg ulcer and et al. to of venous ulcers: a J Guideline pressure wound therapy may be to a by the of in the wound or by and However, experience in venous ulcers is (Level Principle: pressure wound therapy negative pressure to help in wound and help Evidence: et al. clinical of negative pressure use in Surg et al. used for chronic wounds and in the lower extremities. Wound et al. a for wound and animal studies and Surg et al. of therapy of chronic 12: Guideline and therapy have not been to venous ulcer (Level I). Principle: There are and studies that such as and therapy be in the treatment of venous ulcers. evidence not support Evidence: review of therapy for venous leg ulcers. J Wound 8: [STAT]. et al. in the of chronic venous a J Surg et al. the use of wound in chronic venous leg J Wound 14: therapy in chronic leg a Wound [STAT]. et al. Systematic reviews of wound and [STAT]. Guideline may be as an to compression therapy in the treatment of venous ulcers (Level Principle: may be to when used with an adequate compression may ulcer treatment. Evidence: et al. The of as an to for treating venous ulcers: a J Vasc Surg Guideline used in with compression therapy of venous ulcers (Level I). Principle: to the of the leg should the of venous ulcers. Evidence: J, for treating venous leg ulcers. The Cochrane Database of Systematic The Cochrane [STAT]. et al. treatment of venous leg ulcers with of in a Wound et al. Treatment of venous ulcers with a and Angiology et al. Treatment of venous ulcers with a Angiology et al. treatment of venous ulcers of the J in the treatment of venous leg ulcers. 12: JJ, et al. of in the treatment of venous leg ulcers. J Guideline The of or in the treatment of venous ulcers sufficient data to a (Level Principle: and of such as or venous and Evidence: in the treatment of venous ulcers: a et al. treatment of leg ulcers caused by venous or arterial et al. The of on in the treatment of chronic venous leg J 1995; Guideline treatment with may be a to compression therapy in the treatment of leg ulcers (Level I). Principle: Agents that of and oxygen and and should in the of venous ulcers. Evidence: Venous leg a meta-analysis of therapy with Eur J Vasc Endovasc Surg [STAT]. JJ, et al. of a treatment with a on venous ulcer J The of on the of leg ulcers. An open 14: Bergan JJ, approach to chronic venous and of Angiology Clinical of in the most of chronic venous Angiology et al. in the of in chronic venous clinical J Surg Guideline with an such as in with compression therapy may be in treating with venous ulcers. However, one be of (Level Principle: of should be to and in of Evidence: et al. Venous treatment by and J and treatment of venous et al. The clinical of J as a in J 1995; J, Treatment of with in a with J Guideline is not in the treatment of venous leg ulcers (Level I). Principle: to patients a will not of chronic wounds such as venous ulcers. Evidence: for arterial and venous leg ulcers. The Cochrane Database of Systematic The Cochrane [STAT]. Venous leg of treatment, and of and of chronic leg ulcers. J Surg of in the treatment of chronic venous J Preamble: Venous ulcers of the lower extremity are a are as as Therefore, be for ulcers. Guideline with or venous ulcers should use compression and (Level I). Principle: Most not the underlying ambulatory venous pressure (venous a degree of compression is Evidence: The Cochrane Database of Systematic Reviews, The Cochrane [STAT]. and the of venous ulcers. Surg 1996; D et al. for leg ulcer a of two types of compression 1995; Moneta et al. of ambulatory compression therapy for chronic venous ulcers. Surgery et al. venous of the and of an evidence-based of the venous and studies. Angiology [STAT]. Guideline to have been to be in and venous ulcer (Level Principle: been to be with Evidence: in chronic venous a J Vasc Surg of on in patients with chronic venous disease. J Surg was supported by the Wound a to the Wound