Guidelines for the treatment of arterial insufficiency ulcers
2006; Wiley; Volume: 14; Issue: 6 Linguagem: Inglês
10.1111/j.1524-475x.2006.00177.x
ISSN1524-475X
AutoresHarriet W. Hopf, Cristiane M. Ueno, Rummana Aslam, K G Burnand, Caroline E. Fife, Lynne Grant, Allen Holloway, Mark D. Iafrati, Raj Mani, Bruce D. Misare, Noah Rosen, Dag Shapshak, J. Benjamin Slade, Judith West, Adrian Barbul,
Tópico(s)Diabetic Foot Ulcer Assessment and Management
ResumoAn 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, Olin JW, et al. Peripheral arterial disease detection, awareness, and treatment in the primary care. JAMA 2001; 286: 1317–24.] Guideline # 1.1: All patients with lower extremity ulcers should be assessed for arterial disease. The following signs and values predict that arterial disease may be present. Suspicion of arterial disease in the context of a patient with a lower extremity ulcer should prompt referral to a vascular specialist. (Level IA) The ideal way to determine whether a patient requires vascular referral has not been defined by clinical research. Health care providers treating patients with lower extremity ulcers should incorporate these evaluations as appropriate for their particular practice, and should consider patient history in deciding whether a vascular referral is necessary. Decreased or absent palpable pedal pulses (dorsalis pedis and posterior tibialis).3,9,10 If patients present with strong DP and PT pulses, they generally do NOT need to be referred. A lack of pulse should usually lead to referral. There can be anatomic variability. The sensitivity of a nondetectable pulse for diagnosis of PAOD can be 17–32%, whereas the specificity is 97–99%.9 In healthy individuals, DP pulse is not present in 8.1%, PT in 2.9%, and both are absent in < 2%.14 Delay in capillary refill response.1,12 Delay of 10–15 seconds in returning of color when raising the leg to 45° for 1 minute, dependent rubor (Buerger's test).1,12 Ankle Brachial Index (ABI) of ≤0.90. ABI for PAOD vary from<0.80 to<0.97,9,15,16 and a cutoff value of 1.2 should also lead to referral to a vascular specialist, as it is also predictive of angiogram-positive disease. Transcutaneous oxygen tension (TcPO2) on the periwound skin <40 mmHg.7,8,11 Transcutaneous oximetry is not available in every clinic. It is a valuable modality that should be considered in all patients with lower extremity ulcers where it is available. A number of studies have demonstrated that periwound PtcO2 below a cutoff of about 40 mmHg is associated with impaired healing due to inadequate oxygen supply. Clearly, arterial insufficiency results in reduced oxygen supply and thus decreased PtcO2. A large number of studies have looked at the ability of PtcO2 to predict healing of an amputation.17–41 The studies have all been performed in patients scheduled for amputation, and thus, presumably, options for revascularization have been exhausted. These studies specifically assess the relationship between PtcO2 and healing when no effort is made to change PtcO2 (e.g., revascularization). Revascularization would be expected to increase PtcO2 and thus change the predicted outcome. Wutschert and Bounameaux38 performed a meta-analysis to determine the ability of PtcO2 to predict amputation level, using studies published from 1985 to 1996. There were a total of 615 lower limb amputations (51% in patients with diabetes) and the reamputation rate was 16.4%. Failure was defined as more proximal amputation or extensive (operative) debridement of the stump. They found that 20 mmHg was the most useful cutoff for failure to heal, with a sensitivity of 82% and a specificity of 64%. The positive predictive value (failed to heal) of the 20 mmHg cutoff was 92% and the negative predictive value was 42%. The accuracy was 79%. PtcO2 is a more effective marker of disease than Doppler assessment or ankle-brachial indices. Thirty-eight studies since 1982 suggest that hypoxia is defined as PtcO2 below 10–40 mmHg.43−73 Fifteen studies (1137 patients) demonstrated that PtcO2 provides better overall predictive capability than Doppler studies measuring ABI and segmental pressures, or laser fluximetry.42–44,48,49,53,56,58,63,64,68,69 The inability of PtcO2 to provide anatomical information may limit its usefulness for vascular screening.73 PtcO2 has also been used to assess the success of vascular intervention (surgical or endovascular).46,61,62,69−73 These data suggest that PtcO2 may be superior to Doppler in screening for vascular disease, predicting healing after amputation, and assessing the success of vascular intervention. Taken together, these studies suggest that evaluation by a vascular specialist be strongly considered for all patients with periwound PtcO2 <40 mmHg, and should be routine for patients with periwound PtcO2 <20 mmHg unless it would clearly be inappropriate (for example, the patient would refuse to consider surgical intervention). Doppler arterial waveforms disparities.1 Dampened pulse volume recordings.11 Principle: Pure arterial ulcers are unusual. Arterial insufficiency frequently contributes to poor healing in ulcers with another primary etiology such as diabetic neuropathy or venous insufficiency. Evidence: Sieggreen MY, Kline RA. Arterial insufficiency and ulceration—diagnosis and treatment options. Nurse Pract 2004; 29: 46–52. [LIT REV] Hirsch AT, Criqui MH, Treat-Jacobson D, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in the primary care. JAMA 2001; 286: 1317–24. [CLIN S] Mohler III ER. 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Comparison of transcutaneous oximetry and laser Doppler flowmetry as non-invasive predictors of wound healing after excision of extremity soft-tissue sarcomas. Surgery 1994; 115: 335–40. [CLIN S] Yablon SA, Novick ES, Jain SS, Graves DE. Postoperative transcutaneous oxygen measurement in the prediction of delayed wound healing and prosthetic fitting among amputees during rehabilitation. A pilot study. Am J Phys Med Rehabil 1995; 74: 193–8. [CLIN S] Bunt TJ, Holloway GA. TcPO2 as an accurate predictor of therapy in limb salvage. Ann Vasc Surg 1996; 10: 224–7. [CLIN S] Kalani M, Brismar K, Fagrell B, Jorneskog G. Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcer. Diabetes Care 1999; 22: 147–51. [CLIN S] Rhodes GR, Skudder P Jr. Salvage of ischaemic diabetic feet. Role of transcutaneous oxygen mapping and multiple configurations of in situ bypass. Am J Surg 1986; 152: 165–71. [CLIN S] Lalka SG, Malone JM, Anderson GG, Hagamann RM, McIntyre KE. Transcutaneous oxygen and carbon dioxide pressure monitoring to determine limb ischaemia and to predict surgical outcome. J Vasc Surg 1988; 7: 507–14. [CLIN S] Poredos P, Rakovec S, Guzic-Salobir B. Determination of amputation level in ischaemic limbs using tcPO2 measurement. Vasa J Vasc Dis 2005; 34: 108–12. [CLIN S] Hauser CJ, Appel P, Shoemaker WC. Pathophysiologic classification of peripheral vascular disease by positional changes in regional transcutaneous oxygen tension. Surgery 1984 Jun; 95: 689–93. [CLIN S] Kram HB, Appel PL, Shoemaker WC. Comparison of transcutaneous oximetry, vascular hemodynamic measurements, angiography, and clinical findings to predict the success of peripheral vascular reconstruction. Am J Surg 1988; 155: 551–8. [CLIN S] Moosa HH, Peitzman AB, Makaroun MS, Webster MW, Steed DL. Transcutaneous oxygen measurements in lower extremity ischaemia: effects of position, oxygen inhalation and arterial reconstruction. Surgery 1988; 2: 193–8. [CLIN S] Ubbink DT, Jacobs MJHM, Tangelder GJ, Slaaf DW, Reneman RS. The usefulness of capillary microscopy, transcutaneous oximetry and laser Doppler fluximetry in the assessment of the severity of lower limb ischaemia. Int J Microcirc 1994; 14: 34–44. [CLIN S] Ballard JL, Eke CC, Bunt TJ, Killeen JD. A prospective evaluation of transcutaneous oxygen measurements in the management of diabetic foot problems. J Vasc Surg 1995; 22: 485–92. [CLIN S] Katsamouris A, Brewster DC, Megerman J, Cina C, Darling RC, Abbott WM. Transcutaneous oxygen tension in selection of amputation level. Am J Surg 1984; 147: 510–7. [CLIN S] Dowd GS. Predicting stump healing following amputation for peripheral vascular disease using the transcutaneous oxygen monitor. Ann R Coll Surg Engl 1987; 69: 31–5. [CLIN S] Bongard O, Krähenbuhl B. Predicting amputation in severe ischaemia. J Bone Joint Surg 1988; 70B: 465–7. [CLIN S] Scheffler A, Rieger H. A comparative analysis of transcutaneous oximetry (tcPO2) during oxygen inhalation and leg dependency in severe peripheral arterial occlusive disease. J Vasc Surg 1992; 16: 218–24. [CLIN S] Ray SA, Buckenham TM, Bellie A-M, Taylor RS, Dormandy JA. The predictive value of laser Doppler fluxmetry and transcutaneous oximetry for clinical outcome in patients undergoing revascularization for severe leg ischaemia. Eur J Vasc Endovasc Surg 1997; 13: 54–9. [CLIN S] Stalc M, Poredos P. The usefulness of transcutaneous oximetry in assessing the success of percutaneous transluminal angioplasty. Eur J Vasc Endovasc Surg 2002; 24: 528–32. [CLIN S] Wagner HJ, Schmitz R, Alfke H, Klose KJ. Influence of percutaneous transluminal angioplasty on transcutaneous oxygen pressure in patients with peripheral arterial obstructive disease. Radiology 2003; 22: 791–7. [CLIN S] Caselli A, Latini V, Lapenna A, Di Carlo S, Pirozzi F, and two others. Transcutaneous oxygen tension monitoring after successful revascularization in diabetic patients with ischaemic foot ulcers. Diabetic Med 2005; 22: 460–5. [CLIN S] DeGraaff JC, Ubbink DT, Legemate DA, Tijssen JGP, Jacobs MJHM. Evaluation of toe pressure and transcutaneous oxygen measurements in management of chronic leg ischaemia: A diagnostic randomized clinical trial. J Vasc Surg 2003; 38: 528–34. [RCT] Guideline # 1.2: Patients presenting with risk factors for atherosclerosis (smoking, diabetes, hypertension, hypercholesterolemia, advanced age, obesity, hypothyroidism) who have ulcers are more likely to have arterial ulcers and should be carefully and broadly evaluated. Discuss a more complete workup with the primary care physician. (Level IA) Guideline #1.3: In ischemic-appearing ulcers, look for contributing factors other than atherosclerosis that involve the arterial system (microvascular vs. macrovascular), such as thromboangiitis, vasculitis, Raynaud's, pyoderma gangrenosum, thalassemia, or sickle cell disease. (Level IA) Principle: Patients with ulcers that appear “ischemic” should be evaluated for diseases beyond large vessel occlusive disease if the clinical presentation is not completely consistent with atherosclerotic occlusive disease. This generally requires referral to a specialist. Evidence: Hirsch AT, Criqui MH, Treat-Jacobson D, et al. Peripheral arterial disease detection, awareness, and treatment in the primary care. JAMA 2001; 286: 1317–24. [CLIN S] Mohler III ER. Peripheral arterial disease: Identification and implications. Arch Intern Med 2003; 163: 2306–14. [STAT] Norman PE, Eikelboom JW, Hankey GJ. Peripheral arterial disease: prognostic significance and prevention of the atherotrombotic complications. MJA 2004; 181: 150–4. Tesfaye S, Chaturvedi N, Eaton SEM, et al. Vascular risk factors and diabetic neuropathy. N Engl J Med 2005; 352: 341–50. [RCT] Kerstein MD. The non-healing leg ulcer: peripheral vascular disease, chronic venous insufficiency, and ischemic vasculitis. Ostomy Wound Manage. 1996 Nov–Dec; 42(10A Suppl.):19S–35S. [LIT REV] Mekkes JR, Loots MAM, Van der Wal AC, Bos JD. Causes, investigation and treatment of leg ulceration. Br J Dermatol 2003; 148: 388–401. [LIT REV] McDermott MM, Guralnik JM, Ferrucci L, et al. Functional decline in lower-extremity peripheral arterial disease: associations with co-morbidity, gender, and race. J Vasc Surg 2005; 42: 1131–7. [CLIN S] Mekkes JR, Loots MAM, Van der Wal AC, Bos JD. Causes, investigation, and treatment of leg ulceration. Br J Dermatol 2003; 148: 388–401. [LIT REV] Sarkar PK, Ballantyne S. Management of leg ulcers. Postgrad Med F 2000; 76: 674–82. [LIT REV] Kerstein MD. The non-healing leg ulcer: peripheral vascular disease, chronic venous insufficiency and ischemic vasculitis. Ostomy Wound Manage 1996 Nov–Dec; 42(10A Suppl.):19S–35S. [LIT REV] Oien RF, Hakansson A, Hansen BU. Leg ulcers in patients with rheumatoid arthritis—a prospective study of aetiology, wound healing and pain reduction after pinch grafting. Rheumatology 2001; 40: 816–20. [CLIN S] Adler AJ, Boyko EJ, Ahroni JH, Smith DG. Lower-extremity amputation in diabetes. Diabetes Care 1999; 22: 1029–35. [CLIN S] Guideline # 1.4: Patients presenting with rest pain or gangrene should be promptly referred to a vascular specialist. (Level IA) Principle: Ulcers in patients with rest pain and gangrene may progress rapidly, and delay in referral increases the risk of limb loss. Evidence: Adler AJ, Boyko EJ, Ahroni JH, Smith DG. Lower-extremity amputation in diabetes. Diabetes Care 1999; 22: 1029–35. [CLIN S] Treiman GS, Oderich GSC, Ashrafi A, Scneider PA. Management of ischemic heel ulceration and gangrene: An evaluation of factors associated with successful healing. J Vasc Surg 2000; 31: 1110–8. [RETRO S] Grey JE, Hardling KG, Enoch S. Venous and arterial leg ulcers. BMJ 2006; 332: 347–50. [STAT] Sieggreen MY, Kline RA. Arterial insufficiency and ulceration—diagnosis and treatment options. Nurse Pract 2004; 29: 46–52. [LIT REV] Rauwerda JA. Surgical Treatment of the infected diabetic foot. Diabetes Metab Res Rev 2004; 20 (S1): S41–44. [RETRO S] Goshima KR, Mils JL, Hughes JD. A new look at outcomes after infrainguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage. J Vasc Surg 2004; 39: 330–5. [RETRO S] Preamble: In patients with arterial insufficiency ulcers, restoration of blood flow by revascularization is the intervention that will most likely lead to healing. [Grey JE, Hardling KG, Enoch S. Venous and arterial leg ulcers. BMJ 2006; 332: 347–350.] Guideline #2.1: Prior to revascularization, an anatomic road map should be obtained. (Level IIA) Options include: Angiogram1–3,5 Duplex Angiography,5 which has a sensitivity of 99% and 80% and a specificity of 94% and 91% for the femoropopliteal and tibial segments, respectively, as compared with arteriography.6 Magnetic Resonance Angiography4,5 Contrast Tomography Angiography4 Principle: The goal of revascularization (open or endovascular) is to restore in-line arterial blood flow to the ulcer, which may be manifested by a pulse in the foot and/or improved ABI.1 Evidence: Treiman GS, Oderich GSC, Ashrafi A, Scneider PA. Management of ischemic heel ulceration and gangrene: an evaluation of factors associated with successful healing. J Vasc Surg 2000; 31: 1110–8. [RETRO S] Toursarkissian B, D'Ayala M, Stefanidis D, Shirreman PK, Harrison A, Schoolfield J, Sykes MT. Angiographic scoring of vascular occlusive disease in the diabetic foot: relevance to bypass graft patency and limb salvage. J Vasc Surg 2002; 35: 494–500. [CLIN S] Sieggreen MY, Kline RA. Arterial insufficiency and ulceration—diagnosis and treatment options. Nurse Pract 2004; 29: 46–52. [LIT REV] Hingorani A, Ascher E, Markevich et al. A comparison of magnetic resonance angiography, contrast arteriography, and duplex arteriography for patients undergoing lower extremity revascularization. Ann Vasc Surg 2004; 18: 294–301. [CLIN S] Gjoannaess E, Morken B, Sandbaek J, et al. Gadolinium-enhanced magnetic resonance angiography, colour duplex and digital subtraction angiography of the lower limb arteries from the aorta to the tibio-peroneal trunk in patients with intermittent claudication. Eur J Vasc Endovasc Surg 2006; 31. [CLIN S] Katsamouris AN, Giannoukas AD, Tstetis D, et al. Can ultrasound replace arteriography in the management of chronic arterial occlusive disease of the lower limb? Eur J Endovasc Surg 2001; 21:155–60. [CLIN S] Guideline #2.2: In the presence of an arterial ulceration, the natural history is one of disease progression and eventual limb loss, and the treatment options are revascularization (endovascular or open surgery) or amputation. Adjuvant therapies may improve healing of the ulcer but do not correct the underlying vascular disease. They cannot replace revascularization. Revascularization is not always successful and durable. Thus, adjuvant therapy may improve the outcome if combined with revascularization. (Level IIA) Principle: Approximately 10–20% of patients with PAOD will need revascularization surgery. Bypass surgery has a reported patency rate of 70% for crural-pedal bypass in both diabetics and nondiabetics at five years (in survivors), a limb salvage rate of 80% with a 1–2% amputation rate at two years in both diabetics and nondiabetics (the same in diabetic
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