Guidelines For The Treatment Of Arterial Insufficiency Ulcers

1
Guidelines For The Treatment Of Arterial
Insufficiency Ulcers

• Consensus Conference
• Lister Hill Center
• National Institutes of Health
• March 20, 2006

2
Comments

• Send to Adrian Barbul by April 15, 2006
• abarbul_at_jhmi.edu

3
Committee

• Harriet W. Hopf, MD - Chair
• Cristiane Ueno, MD (Overall)
• Rummana Aslam, M.D.
• Professor Kevin Burnand
• Lynne Grant MS, RN, CWOCN
• Allen Holloway, MD
• Mark D. Iafrati, MD
• Dr. Raj Mani
• Bruce Misare, MD
• Noah Rosen, MD (Diagnosis, Surgery)
• Dag Shapshak, MD (Wound Bed Prep, Adjuvant, Long
  Term)
• J. Benjamin Slade, Jr., MD
• Judith West, RN, DNS

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Methodology

• Followed the format of the other guidelines
• Appropriate topic areas identified by committee
• Articles obtained, distributed, and reviewed
• Additional articles obtained
• Conference calls to define and reach consensus on
  specific guidelines

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Methodology

• Our goal is to help clinicians make decisions
• The Cochrane reports review perfect evidence
  only
• We focused on best evidence in order to be able
  to make a recommendation when inadequate data
  exist

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Levels of Evidence

• Level I
• At least 2 RCTs and / or meta-analysis and / or
  multiple laboratory or animal experiments with at
  least two clinical series supporting the
  laboratory results.
• Level II
• At least one RCT and at least two significant
  clinical series or expert opinion papers with
  literature reviews. Convincing experimental
  evidence without adequate human experience.
• Level III
• Animal or human data suggesting
  proof-of-principle.
• Conclusions may be positive (treatment in
  question should be used) or negative (treatment
  in question should not be used).

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Categories Reviewed

• Diagnosis
• Surgery
• Infection Control
• Wound Bed Preparation
• Dressings
• Adjuvant Therapy
• Device, Systemic, Local / Topical
• Long-term Maintenance

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Special Considerations

• Arterial ulcers represent a continuum
• Mildly impaired arterial inflow
• Delayed but intact healing
• Critical Limb Ischemia
• Rapid progression without correction
• Arterial ulcers represent two conditions
• Prior to revascularization
• After revascularization

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Special Considerations

• Guidelines are primarily aimed at
• Appropriate referral to a vascular specialist
• Not appropriate interventions for
  revascularization
• Appropriate treatment of revascularized ulcers
• Local care and adjunctive treatments
• Appropriate treatment when revascularization is
  impossible or inadequate
• Local care and adjunctive treatments

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Diagnosis add levels

• All patients with ulcers should be assessed for
  arterial disease. (Level I)
• Pedal pulses
• Ankle brachial index
• Patients with absent or reduced pulses or ABI
  0.9 should be considered for referral to a
  vascular specialist. (Level I)
• Assess capillary refill, dependent rubor, foot
  temperature as confirmatory measure

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Diagnosis

• Patients presenting with risk factors for
  atherosclerosis who have ulcers are more likely
  to have arterial ulcers and should be carefully
  evaluated. (Level I)
• In ischemic appearing ulcers, look for
  contributing factors other than atherosclerosis
  that involve the arterial system. (Level I)
• Patients with an ulcer and rest pain or gangrene
  should be promptly referred to a vascular
  specialist. (Level I)

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Surgery

• Prior to revascularization, an anatomic roadmap
  should be obtained (Level II)
• In the presence of an arterial ulceration, the
  natural history is one of disease progression and
  eventual limb loss (Level I)
• Treatment options are revascularization
  (endovascular or open surgery) or amputation
• Adjuvant therapies may improve healing but do not
  correct the underlying vascular disease

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Surgery

• Revascularization does not always result in a
  perfused foot or adequate inflow of oxygen to
  guarantee ulcer healing in the foot. (Level II)
• Adjunctive agents should be considered in such
  patients
• Early amputation should be considered in some
  patients

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Surgery

• After revascularization, flaps and skin grafts
  may be beneficial for wound coverage. (Level II)
• Requires appropriate infection control and wound
  bed preparation

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Infection Control

• In general removal of all necrotic or devitalized
  tissue by debridement leads to a more normal
  wound healing process. (Level II)
• In arterial ulcers with dry gangrene or eschar,
  however, debridement should not be attempted
  until arterial in-flow has been re-established.
  (Level III)

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Infection Control

• Patients with neuro-ischemic ulcers should be
  considered for aggressive treatment with a short
  course of systemic antibiotics even when clinical
  signs of infection are not present. (Level II)
• Chronic treatment with systemic antibiotics does
  not prevent infection and may worsen outcome if
  infection develops. (Level II)
• Routine use of antibiotics should be avoided, and
  antibiotics should be stopped if no response
  occurs.

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Infection Control /Wound Bed Preparation

• Wounds will heal and infection will be better
  prevented and controlled in an environment that
  is adequately oxygenated. (Level I)
• Revascularization (Level I)
• Maximizing surface flow with warmth, hydration,
  pain control, and reducing systemic
  vasoconstrictors (Level III)
• Increased inspired oxygen (Level II)

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Wound Bed Preparation

• Evaluate the patient as a whole, identifying and
  addressing the causes of tissue damage. (Level
  II)
• Address systemic diseases and medications,
  nutrition, and tissue perfusion and oxygenation.

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Wound Bed Preparation

• Debridement of nonviable and uninfected tissue is
  performed only after the revascularization
  procedure. (Level II)
• Pre-revascularization debridement is indicated in
  a septic foot with and without ischemic signs
  (Level II)
• Edema and infection can lead to digital arterial
  thrombosis.

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Wound Bed Preparation

• Many debriding agents may be useful (Level II)
• Sharp, enzymatic, mechanical, biological,
  autolytic
• There is no consensus about the best agent
• Varies with ulcer presentation, health care
  provider expertise, and other factors

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Wound Bed Preparation

• Edema impairs wound healing and should be
  controlled.
• Excessive compression may be harmful in patients
  with arterial disease.
• Research is required to establish guidelines for
  compression in patients with a significant
  arterial component to their ulcer.

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Dressings

• In arterial ulcers with sufficient arterial
  inflow to support healing, use a dressing that
  will maintain a moist wound-healing environment.
  (Level II)
• Dry gangrene or eschar is best left dry until
  revascularization is successful.

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Dressings

• In ulcers with sufficient arterial inflow,
  autografts and allografts act as a biological
  dressing and may increase the chance of wound
  healing (Level II)
• Further study is required in arterial ulcers
• Level III

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Dressings

• Select a moist dressing that is cost effective
  and appropriate to the ulcer etiology and the
  health care provider.
• Dressings should be changed once daily or less
  often where possible.
• Level II

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Adjuvant Therapy

• Adjuvant agents cannot replace revascularization.
• When revascularization is impossible or
  unsuccessful or when successful revascularization
  does not result in healing, adjuvant agents may
  be useful.
• Adjuvant therapy may also be useful in assuring
  healing in combination with revascularization.
• More research is needed to define the proper use
  (timing, dosage, etc) of most adjuvant therapies.

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Adjuvant Therapy

• Promising or potentially promising therapies that
  require more research
• RCTs
• Specific to arterial ulcers
• Information on proper use
• Ultrasound (Level III)
• Electrical stimulation (Level II)
• Spinal cord stimulation (Level II)
• Percutaneous lumbar sympathetic block (Level III)
• LMWH (Level II)

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Adjuvant Therapy

• Promising or potentially promising therapies that
  require more research
• RCTs
• Specific to arterial ulcers
• Information on proper use
• Intermittent pneumatic leg compression (Level II)
• Cilostazol (Level III)
• Prostaglandins (Level III)
• Stem cell therapy (Level III)
• Gene therapy (Level III)
• Topical reduced pressure therapy (Level III)

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Adjuvant Therapy

• Hyperbaric oxygen therapy (systemic)
• Benefit demonstrated in Wagner Grade 3 ischemic
  (revascularized when possible) ulcers in patients
  with diabetes (Level I)
• Studies are required to determine whether these
  results can be generalized to all ischemic ulcers
• Benefit in ischemia-reperfusion injury in other
  settings (gas embolism, compromised flaps,
  decompression sickness, carbon monoxide
  poisoning) demonstrated (Level I)
• Studies are required to determine whether
  post-revascularization treatment is of benefit

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Adjuvant Therapy

• Topical oxygen therapy (Level III)
• Literature that supports systemic HBO2 does not
  pertain to topical oxygen
• Basic science and case series suggest potential
  benefit in non-arterial ulcers
• Research required to evaluate use in arterial
  ulcers
• Little penetration of topical oxygen
• Potential benefit unclear if hypoxia is only
  corrected at the surface

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Adjuvant Therapy

• Agents that are not recommended
• Lack of efficacy demonstrated
• Pentoxifylline (Level I)
• Useful in venous insufficiency ulcers
• Anticoagulants (Level I)

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Long Term Maintenance

• Risk factor reduction (Level I)
• Smoking cessation
• Control of
• diabetes
• hyperlipidemia
• hypertension
• elevated homocysteine levels
• Exercise to increase arterial blood flow (Level I)

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Long Term Maintenance

• Anti-coagulation therapy (Level II)
• Aspirin
• Clopidogrel
• Ticlodipine
• LMWH
• Use and efficacy not well delineated

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Conclusions

• Draft statement
• Comments welcome
• abarbul_at_jhmi.edu
• Will be incorporated with consensus from
  committee members
• Few Level I Guidelines
• More research in arterial ulcers required