Evidence-Based Algorithm for Venous Leg Ulcers
Evidence-Based Algorithm for Venous Leg Ulcers
Over the years, clinicians have been faced with numerous treatments for VLUs. Some current products and treatments have minimal to no evidence to show that they are effective. The goal of the algorithm is to treat VLUs with the best evidence to close them sooner and more cost effectively.
The CEAP classification system was originally developed in 1994 by an international ad hoc committee of the American Venous Forum and adopted worldwide to facilitate meaningful communication about CVD, and to serve as a basis for scientific analysis of CVD and treatment options. The management of a patient with a suspected VLU begins with a comprehensive medical history and detailed physical examination. The medical history should include documentation of previous manifestations of CVD and previous and current ulcers. Preceding episodes of malignancy, vasculitis, collagen-vascular diseases, and dermal manifestations of systemic diseases should be identified. Suspected chronic VLUs that increase in size after debridement, or are excessively painful, should be reevaluated for possible underlying etiologies.
An important goal of the physical examination is to document or exclude the presence of CVD. Physical examination should include evaluation of ulcers, venous dilatation, edema, skin pigmentation, and venous refill time. A detailed history should be performed, especially if there is a healed or active ulcer. If there is a current venous ulcer, a physical exam with descriptive terms is important. The exam should be done with the patient both supine and standing.
Venous dilatation should be described and examined by both visualization and palpation. Description of a dilated vein can range from telangiectases to reticular veins to varicose veins.
Edema indicates the disease has progressed and is functionally advanced. The extent of the edema should be described and the limbs should be circumferentially measured.
Skin pigmentation changes, such as venous eczema and lipodermatosclerosis, are important signs of severe chronic disease. Any and all pigmentation changes should be described.
Venous ulceration is the sign of the most advanced disease. The location and the measurement of the ulcer should be well described, along with any healed ulcers that have scarring.
Venous refill time provides an overall measurement of venous reflux. Venous leg ulcers may exist in the presence of mixed arterial/venous pathology, and treatment of only the elevated venous pressure will be unsuccessful when significant arterial disease is present. 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. If concurrent arterial disease is present, this should be evaluated and addressed. When present, patients should not have traditional compressive dressings. The complexity of the diagnostic work-up is influenced by the severity of the clinical problem and the degree of disability. An international consensus conference was held in 1994 at the American Venous Forum to develop a new classification system of CVD. The CEAP classification was developed and implemented, and is broken down into 4 components:
There are 7 clinical classes from 0 to 6, with 0 indicating no disease; 1 indicating signs of telangiectasia or reticular veins; 2 indicating varicose veins; 3 indicating edema without skin changes; 4 indicating skin changes associated with venous disease; 5 indicating skin changes with healed ulcers; and 6 indicating skin changes with active ulceration.
The type of dysfunction is classified as either congenital, primary, or secondary. Congenital dysfunctions are noted at birth, but don't manifest until later in life. Primary dysfunction is of an unknown cause, while secondary dysfunction is an acquired condition such as deep vein thrombosis.
Anatomic sites of venous disease are either superficial, deep, and/or perforating. One system or all systems simultaneously can be involved in the same time.
Signs or systems of CVD result from reflux, obstruction, or both. This classification system is very detailed and can be used to direct treatment for surgical vs conservative treatment. The one fault of the system is that there is no classification for other concurrent conditions that might affect the severity or treatment of CVD. Important considerations for other diseases, such as diabetes and lymphedema, need to be taken into account because they might affect the treatment and healing times.
The diagnostic tests useful in CVD have been classified into 3 levels: I = office testing (eg, history, physical examination, and continuous-wave ([handheld] Doppler studies); II = vascular laboratory (eg, duplex scanning, plethysmography, and venous pressure); and III = phlebography (eg, ascending and descending phlebography and varicography). All patients should undergo level I diagnostic studies, in which the minimal degree of objective testing is achieved by the continuous-wave Doppler examination. Level II diagnostic investigations are done for patients with the simplest and most straightforward problems, and level III diagnostic studies are reserved for difficult cases and preoperative planning, especially for patients undergoing deep venous reconstruction.
Baseline clinical features of VLUs can help identify patients who are likely to respond to conservative treatment and those who may require more aggressive interventions. Margolis et al analyzed a dataset of more than 20,000 patients with VLUs treated with lower limb compression therapy to determine the accuracy of several prognostic models. Initial measures of wound size and duration accurately identified patients who were likely to heal by the 24th week of care. For example, a wound < 10 cm and < 12 months old at the first visit has a 29% chance of not healing by the 24th week of care, while a wound > 10 cm and > 12 months old has a 78% chance of not healing. These criteria may help wound care providers decide when to consider using conservative treatments only, or in addition to, adjuvant therapies early in the course of VLU treatment.
The treatment options can be broken down to 5 categories: compression, local wound care, surgical intervention, medical treatment, and advanced technology. Basic wound care principles also need to be followed, such as proper wound environment, control of clinical signs of infection, and debridement. In a recent review of the impact of debridement on healing of VLUs, ulcer surface area reduction was greater in visits after debridement. Attention should be paid to removal of all necrotic tissue, densely adherent slough and exudates, and reshaping of the ulcer margins.
Venous Leg Ulcer Treatment Algorithm
Over the years, clinicians have been faced with numerous treatments for VLUs. Some current products and treatments have minimal to no evidence to show that they are effective. The goal of the algorithm is to treat VLUs with the best evidence to close them sooner and more cost effectively.
The CEAP classification system was originally developed in 1994 by an international ad hoc committee of the American Venous Forum and adopted worldwide to facilitate meaningful communication about CVD, and to serve as a basis for scientific analysis of CVD and treatment options. The management of a patient with a suspected VLU begins with a comprehensive medical history and detailed physical examination. The medical history should include documentation of previous manifestations of CVD and previous and current ulcers. Preceding episodes of malignancy, vasculitis, collagen-vascular diseases, and dermal manifestations of systemic diseases should be identified. Suspected chronic VLUs that increase in size after debridement, or are excessively painful, should be reevaluated for possible underlying etiologies.
An important goal of the physical examination is to document or exclude the presence of CVD. Physical examination should include evaluation of ulcers, venous dilatation, edema, skin pigmentation, and venous refill time. A detailed history should be performed, especially if there is a healed or active ulcer. If there is a current venous ulcer, a physical exam with descriptive terms is important. The exam should be done with the patient both supine and standing.
Venous dilatation should be described and examined by both visualization and palpation. Description of a dilated vein can range from telangiectases to reticular veins to varicose veins.
Edema indicates the disease has progressed and is functionally advanced. The extent of the edema should be described and the limbs should be circumferentially measured.
Skin pigmentation changes, such as venous eczema and lipodermatosclerosis, are important signs of severe chronic disease. Any and all pigmentation changes should be described.
Venous ulceration is the sign of the most advanced disease. The location and the measurement of the ulcer should be well described, along with any healed ulcers that have scarring.
Venous refill time provides an overall measurement of venous reflux. Venous leg ulcers may exist in the presence of mixed arterial/venous pathology, and treatment of only the elevated venous pressure will be unsuccessful when significant arterial disease is present. 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. If concurrent arterial disease is present, this should be evaluated and addressed. When present, patients should not have traditional compressive dressings. The complexity of the diagnostic work-up is influenced by the severity of the clinical problem and the degree of disability. An international consensus conference was held in 1994 at the American Venous Forum to develop a new classification system of CVD. The CEAP classification was developed and implemented, and is broken down into 4 components:
Clinical Classification
There are 7 clinical classes from 0 to 6, with 0 indicating no disease; 1 indicating signs of telangiectasia or reticular veins; 2 indicating varicose veins; 3 indicating edema without skin changes; 4 indicating skin changes associated with venous disease; 5 indicating skin changes with healed ulcers; and 6 indicating skin changes with active ulceration.
Etiologic Classification
The type of dysfunction is classified as either congenital, primary, or secondary. Congenital dysfunctions are noted at birth, but don't manifest until later in life. Primary dysfunction is of an unknown cause, while secondary dysfunction is an acquired condition such as deep vein thrombosis.
Anatomic Classification
Anatomic sites of venous disease are either superficial, deep, and/or perforating. One system or all systems simultaneously can be involved in the same time.
Pathophysiologic Classification
Signs or systems of CVD result from reflux, obstruction, or both. This classification system is very detailed and can be used to direct treatment for surgical vs conservative treatment. The one fault of the system is that there is no classification for other concurrent conditions that might affect the severity or treatment of CVD. Important considerations for other diseases, such as diabetes and lymphedema, need to be taken into account because they might affect the treatment and healing times.
The diagnostic tests useful in CVD have been classified into 3 levels: I = office testing (eg, history, physical examination, and continuous-wave ([handheld] Doppler studies); II = vascular laboratory (eg, duplex scanning, plethysmography, and venous pressure); and III = phlebography (eg, ascending and descending phlebography and varicography). All patients should undergo level I diagnostic studies, in which the minimal degree of objective testing is achieved by the continuous-wave Doppler examination. Level II diagnostic investigations are done for patients with the simplest and most straightforward problems, and level III diagnostic studies are reserved for difficult cases and preoperative planning, especially for patients undergoing deep venous reconstruction.
Baseline clinical features of VLUs can help identify patients who are likely to respond to conservative treatment and those who may require more aggressive interventions. Margolis et al analyzed a dataset of more than 20,000 patients with VLUs treated with lower limb compression therapy to determine the accuracy of several prognostic models. Initial measures of wound size and duration accurately identified patients who were likely to heal by the 24th week of care. For example, a wound < 10 cm and < 12 months old at the first visit has a 29% chance of not healing by the 24th week of care, while a wound > 10 cm and > 12 months old has a 78% chance of not healing. These criteria may help wound care providers decide when to consider using conservative treatments only, or in addition to, adjuvant therapies early in the course of VLU treatment.
Treatment
The treatment options can be broken down to 5 categories: compression, local wound care, surgical intervention, medical treatment, and advanced technology. Basic wound care principles also need to be followed, such as proper wound environment, control of clinical signs of infection, and debridement. In a recent review of the impact of debridement on healing of VLUs, ulcer surface area reduction was greater in visits after debridement. Attention should be paid to removal of all necrotic tissue, densely adherent slough and exudates, and reshaping of the ulcer margins.
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