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A summary
Disclaimer 
The information contained in this document is intended to provide general information only. It is not intended to be, nor does it constitute, medical advice. Under no circumstances is the information contained in this document to be interpreted as a recommendation for a particular treatment for specific individuals. In all cases it is recommended that clinicians perform their own interpretations of data in conjunction with the clinical assessment of their patient. 
Due to Perimed’scommitment to continuous improvement of our products, all specifications are subject to change without notice. 
All information and content in this document is protected by copyright. All rights are reserved. Users are prohibited from modifying, copying, distributing, transmitting, displaying, publishing, selling, licensing, creating derivative works, or using any information available in or through the document for commercial or public purposes. All responsibility for any liability, loss or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any of the material in this document is specifically disclaimed.
Introduction 
The aim of this document is to summarize the recommendations and diagnostic guidelines provided by different societies and associations for the assessment of peripheral arterial disease, critical limb ischemia, diabetic foot ulcers and chronic wounds.
Guidelines and Consensus Documents 
Document 
Society/Association 
Published 
Practical guidelines on the management and prevention of the diabetic foot 
IWGDF–International Working Group on the Diabetic Foot 
2007, 2012 
Guidelines for Critical Limb Ischemia and Diabetic Foot 
ESVS (European Society for Vascular Surgery) CLI Guideline Committee 
2011 
ACC/AHA 2005 Guidelines for the Management of PatientsWith Peripheral Arterial Disease: Executive Summary, Update 2011 
ACC/AHA (American Collage of Cardiology/American Heart Association) 
2005, 2011 
TranscutaneousOximetryin Clinical Practice: Consensus statements from an expert panel based on evidence 
Fife CE,SmartDE, Sheffield PJ, HopfHW, Hawkins G, Clarke D 
2009 
Comprehensive Foot Examination and Risk Assessment 
ADA (American Diabetes Association ) 
2008 
Inter-Society consensus for the Management of Peripheral Arterial Disease 
TASCII 
2007
Guidelines and Consensus Documents 
Trust ABI when low but not when high. An ABI < 0.6 indicates significant ischemia in respect to wound healing potential, whereas an ABI > 0.6 has little predictive value and, therefore, at least the toe pressure should be measured. 
Topreventadelayinvascularconsultationandrevascularization,earlynon-invasivevascularevaluationisimportantinidentifyingpatientswithpoorulcerhealingandahighriskforamputation. 
Critical Limb Ischemia is a clinical diagnosis but should be supported by objective tests. 
85 % of ampuations may be prevented by early detection and appropriate treatment. 
In CLI, there is a maldistribution of the skin microcirculation in addition to a reduction in total flow.” 
Every foot ulcer should be examined for the presence of ischemia. 
All diabetic patients with an ulceration should be evaluated for Peripheral Arterial Disease using objective tests. 
Exclude ischemia 
Rely not only on ABI 
Time is important
IWGDF 
International Working Group on the Diabetic Foot 
Practical guidelines on the management and prevention of the diabetic foot 2012, 2007
In allpatients with diabetes and a foot ulcer, evaluate PAD 
Clinical history: 
History to identify symptoms of PAD. 
Palpation of pulses in the lower limb. 
Non-invasive screening tests: 
Hand-held Doppler evaluation of flow signals from both foot arteries 
Ankle-Brachial Index (ABI) 
Toe-Brachial Index when ABI is uncertain 
PAD is likely when: 
The patient has claudicationor rest pain. 
Both foot pulses are absent to palpation. 
Absent or monophasicDoppler signals from one or both foot arteries 
TBI < 0.7 
ABI < 0.9 
Assess severity of PAD (wound healing potential) 
Mild PAD: 
Palpable foot pulses 
Toe pressure > 55 mmHg 
tcpO2> 50 mm Hg 
ABI > 0.6* 
Evaluate the effect of maximum 6 weeks optimal wound care. Reassess perfusion and consider duplex ultrasound or angiography when wound healing response is poor. 
*Note: ABI > 0.6 has less predictive value, and in these patients, tcpO2or toe pressure should be measured. 
Severe PAD 
Significant ischemia, severely impaired wound healing: 
Toe pressure < 50 mmHg 
tcpO2< 30 mm Hg 
ABI < 0.6 
Consider revascularization
ESVS 
European Society for Vascular Surgery, 
CLI Guideline Committee 
Guidelines for Critical Limb Ischemia and Diabetic Foot, 2011
All patients with ulcers and gangrene of the extremity 
Confirm clinical signs and assess severity with objective tests such as distal pressures and microcirculatory assessment (mainly forefoot tcpO2). 
ABI < 0.5 
Toe pressure < 30 mmHg 
tcpO2 < 30 mmHg 
Note: ABI is not a reliable parameter in patients with CLI, toe pressure is more reliable. 
Look for clinical signs for CLI: 
Rest pain, ulcers, prolonged refilling of superficial veins and capillaries on the foot, Buergerstest 
Note: Ischemic rest pain may be reduced or abolished due to sensory neuropathy. 
Risk stratification to identify the best management for each CLI patient. 
Forefoot tcpO2is probably the best non-invasive method for quantification of ischemia severity and prognostic assessment 
Supine forefoot tcpO2value 
Prognosis 
> 35 –40 mmHg 
Local prognosis fairly good even with conservative management 
10 –35 mmHg 
Local prognosis is intermediate 
≤ 10 mmHg 
Local prognosis is very poor
All patients with ulcers and gangrene of the extremity 
Further risk stratification to identify the best management for each CLI patient. 
Severity of CLI 
Supine tcpO2value 
Sitting positionor under oxygen inhalation tcpO2value 
Prognosis 
Degree 1 
10 mmHg <forefoot tcpO2 
≤ 35 mmHg 
Best prognosis 
Degree 2 
forefoot tcpO2 ≤ 10 mmHg 
Clear increasein tcpO2value 
(≥ 40 mmHg) 
Degree 3 
forefoot tcpO2 ≤ 10 mmHg 
Inadequate increase forefoot tcpO2< 30-40 mmHg 
Degree 4 
forefoot tcpO2 ≤ 10 mmHg 
forefoot tcpO2 ≤ 10 mmHg 
Very poor prognosis
ACC/AHA 
American College of Cardiology 
American Heart Association 
ACC/AHA 2005 Guidelines for the Management of Patients with Peripheral Arterial Disease: Executive Summary, Update 2011
Confirmation of PAD 
> 1.40 
TBI 
0.91 -0.99 
Measure ABI after treadmill 
(TBI, segmental pressures, duplex ultrasound examination) 
Decreased post exercise ABI 
≤ 0.90 
Diagnosis of PAD 
Resting ABI should be measured in both legs in patients with excertionalleg symptoms, non-healing wounds, age 65 years and older, or 50 years and older with a history of smoking or diabetes. 
Ankle/Brachial Index (ABI) in both legs 
Vascular laboratories could use segmental pressures, Doppler wave form analysis, pulse volume recording, or ABI with duplex ultrasonography(or combinations of these methods) to document the presence and location of PAD in the lower extremities. 
Leg segmental pressures are useful to establish the lower extremity PAD diagnosis when anatomic localization of lower extremity PAD is required to create a therapeutic plan.
Expert panel : 
Fife, Smart, Sheffield, Hopf, Hawkins, Clarke 
TranscutaneousOximetryin Clinical Practice: Consensus statements from an expert panel based on evidence, 2009
tcpO2for wound healing and amputation level
tcpO2 for hyperbaric treatment 
•tcpO2 values in-chamber 
•tcpO2 values during oxygen challenge test 
Values in-chamber tcpO2 
> 200 mmHg 
(26.7 kPa) 
Benefit from hyperbaric oxygen therapy likely 
< 100 mmHg 
(13.3 kPa) 
Benefit from hyperbaric oxygen therapy unlikely 
Transcutaneous Oximetry in Clinical Practice: Consensus statements from an expert panel based on evidence. C. E FIFE, D. R. SMART, P. J. SHEFFIELD, H. W. HOPF, G. HAWKINS , D CLARKE , J Undersea and Hyp Med Vol. 36, No. 1 p 43-53, 2009 
Values duringO2challenge 
> 35 mmHg (4.7 kPa) and> 50 % increase compared to valuein air 
Benefit from hyperbaric oxygen therapy likely
Summary tcpO2 
•Hear Dr. Caroline Fife summarize the information from this document: http://www.perimed- instruments.com/diagnosing-PAD#tcpo2 
Transcutaneous Oximetry in Clinical Practice: Consensus statements from an expert panel based on evidence. C. E FIFE, D. R. SMART, P. J. SHEFFIELD, H. W. HOPF, G. HAWKINS , D CLARKE , J Undersea and Hyp Med Vol. 36, No. 1 p 43-53, 2009
ADA 
American Diabetes Association 
Comprehensive Foot Examination and Risk Assessment, 2008
In patients with diabetes: Vascular assessment to define overall lower extremity risk status 
Clinical history: 
Vascular symptoms: 
Claudication, rest pain, non-healing ulcer. 
In patients with ABI > 1.3: 
Toe pressure 
tcpO2 
Note: ABI may be misleading in diabetes because of incompressible arteries resulting in falsely elevated ABI. 
Vascular foot exam: 
Palpation of posterior tibialand dorsalispedis 
In patients with absent pulses or signs/symptoms of vascular disease, 
In all diabetic patients over 50 years : 
Ankle-Brachial Index (ABI) 
Assign foot risk category 
Apart from vascular status, other parameters such as neurological assessment are included in the risk assessment. 
ABI < 0.8 claudication 
ABI < 0.4 tissue necrosis 
ABI > 0.9 normal
TASC II 
Inter-Society consensus for the Management of Peripheral Arterial Disease, 2007
* In addition: PVR, VWF, Duplex imaging 
*
Thank You! 
Please visitwww.perimed-instruments.com

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Diagnostic guidelines for peripheral arterial disease

  • 2. Disclaimer The information contained in this document is intended to provide general information only. It is not intended to be, nor does it constitute, medical advice. Under no circumstances is the information contained in this document to be interpreted as a recommendation for a particular treatment for specific individuals. In all cases it is recommended that clinicians perform their own interpretations of data in conjunction with the clinical assessment of their patient. Due to Perimed’scommitment to continuous improvement of our products, all specifications are subject to change without notice. All information and content in this document is protected by copyright. All rights are reserved. Users are prohibited from modifying, copying, distributing, transmitting, displaying, publishing, selling, licensing, creating derivative works, or using any information available in or through the document for commercial or public purposes. All responsibility for any liability, loss or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any of the material in this document is specifically disclaimed.
  • 3. Introduction The aim of this document is to summarize the recommendations and diagnostic guidelines provided by different societies and associations for the assessment of peripheral arterial disease, critical limb ischemia, diabetic foot ulcers and chronic wounds.
  • 4. Guidelines and Consensus Documents Document Society/Association Published Practical guidelines on the management and prevention of the diabetic foot IWGDF–International Working Group on the Diabetic Foot 2007, 2012 Guidelines for Critical Limb Ischemia and Diabetic Foot ESVS (European Society for Vascular Surgery) CLI Guideline Committee 2011 ACC/AHA 2005 Guidelines for the Management of PatientsWith Peripheral Arterial Disease: Executive Summary, Update 2011 ACC/AHA (American Collage of Cardiology/American Heart Association) 2005, 2011 TranscutaneousOximetryin Clinical Practice: Consensus statements from an expert panel based on evidence Fife CE,SmartDE, Sheffield PJ, HopfHW, Hawkins G, Clarke D 2009 Comprehensive Foot Examination and Risk Assessment ADA (American Diabetes Association ) 2008 Inter-Society consensus for the Management of Peripheral Arterial Disease TASCII 2007
  • 5. Guidelines and Consensus Documents Trust ABI when low but not when high. An ABI < 0.6 indicates significant ischemia in respect to wound healing potential, whereas an ABI > 0.6 has little predictive value and, therefore, at least the toe pressure should be measured. Topreventadelayinvascularconsultationandrevascularization,earlynon-invasivevascularevaluationisimportantinidentifyingpatientswithpoorulcerhealingandahighriskforamputation. Critical Limb Ischemia is a clinical diagnosis but should be supported by objective tests. 85 % of ampuations may be prevented by early detection and appropriate treatment. In CLI, there is a maldistribution of the skin microcirculation in addition to a reduction in total flow.” Every foot ulcer should be examined for the presence of ischemia. All diabetic patients with an ulceration should be evaluated for Peripheral Arterial Disease using objective tests. Exclude ischemia Rely not only on ABI Time is important
  • 6. IWGDF International Working Group on the Diabetic Foot Practical guidelines on the management and prevention of the diabetic foot 2012, 2007
  • 7. In allpatients with diabetes and a foot ulcer, evaluate PAD Clinical history: History to identify symptoms of PAD. Palpation of pulses in the lower limb. Non-invasive screening tests: Hand-held Doppler evaluation of flow signals from both foot arteries Ankle-Brachial Index (ABI) Toe-Brachial Index when ABI is uncertain PAD is likely when: The patient has claudicationor rest pain. Both foot pulses are absent to palpation. Absent or monophasicDoppler signals from one or both foot arteries TBI < 0.7 ABI < 0.9 Assess severity of PAD (wound healing potential) Mild PAD: Palpable foot pulses Toe pressure > 55 mmHg tcpO2> 50 mm Hg ABI > 0.6* Evaluate the effect of maximum 6 weeks optimal wound care. Reassess perfusion and consider duplex ultrasound or angiography when wound healing response is poor. *Note: ABI > 0.6 has less predictive value, and in these patients, tcpO2or toe pressure should be measured. Severe PAD Significant ischemia, severely impaired wound healing: Toe pressure < 50 mmHg tcpO2< 30 mm Hg ABI < 0.6 Consider revascularization
  • 8. ESVS European Society for Vascular Surgery, CLI Guideline Committee Guidelines for Critical Limb Ischemia and Diabetic Foot, 2011
  • 9. All patients with ulcers and gangrene of the extremity Confirm clinical signs and assess severity with objective tests such as distal pressures and microcirculatory assessment (mainly forefoot tcpO2). ABI < 0.5 Toe pressure < 30 mmHg tcpO2 < 30 mmHg Note: ABI is not a reliable parameter in patients with CLI, toe pressure is more reliable. Look for clinical signs for CLI: Rest pain, ulcers, prolonged refilling of superficial veins and capillaries on the foot, Buergerstest Note: Ischemic rest pain may be reduced or abolished due to sensory neuropathy. Risk stratification to identify the best management for each CLI patient. Forefoot tcpO2is probably the best non-invasive method for quantification of ischemia severity and prognostic assessment Supine forefoot tcpO2value Prognosis > 35 –40 mmHg Local prognosis fairly good even with conservative management 10 –35 mmHg Local prognosis is intermediate ≤ 10 mmHg Local prognosis is very poor
  • 10. All patients with ulcers and gangrene of the extremity Further risk stratification to identify the best management for each CLI patient. Severity of CLI Supine tcpO2value Sitting positionor under oxygen inhalation tcpO2value Prognosis Degree 1 10 mmHg <forefoot tcpO2 ≤ 35 mmHg Best prognosis Degree 2 forefoot tcpO2 ≤ 10 mmHg Clear increasein tcpO2value (≥ 40 mmHg) Degree 3 forefoot tcpO2 ≤ 10 mmHg Inadequate increase forefoot tcpO2< 30-40 mmHg Degree 4 forefoot tcpO2 ≤ 10 mmHg forefoot tcpO2 ≤ 10 mmHg Very poor prognosis
  • 11. ACC/AHA American College of Cardiology American Heart Association ACC/AHA 2005 Guidelines for the Management of Patients with Peripheral Arterial Disease: Executive Summary, Update 2011
  • 12. Confirmation of PAD > 1.40 TBI 0.91 -0.99 Measure ABI after treadmill (TBI, segmental pressures, duplex ultrasound examination) Decreased post exercise ABI ≤ 0.90 Diagnosis of PAD Resting ABI should be measured in both legs in patients with excertionalleg symptoms, non-healing wounds, age 65 years and older, or 50 years and older with a history of smoking or diabetes. Ankle/Brachial Index (ABI) in both legs Vascular laboratories could use segmental pressures, Doppler wave form analysis, pulse volume recording, or ABI with duplex ultrasonography(or combinations of these methods) to document the presence and location of PAD in the lower extremities. Leg segmental pressures are useful to establish the lower extremity PAD diagnosis when anatomic localization of lower extremity PAD is required to create a therapeutic plan.
  • 13. Expert panel : Fife, Smart, Sheffield, Hopf, Hawkins, Clarke TranscutaneousOximetryin Clinical Practice: Consensus statements from an expert panel based on evidence, 2009
  • 14. tcpO2for wound healing and amputation level
  • 15. tcpO2 for hyperbaric treatment •tcpO2 values in-chamber •tcpO2 values during oxygen challenge test Values in-chamber tcpO2 > 200 mmHg (26.7 kPa) Benefit from hyperbaric oxygen therapy likely < 100 mmHg (13.3 kPa) Benefit from hyperbaric oxygen therapy unlikely Transcutaneous Oximetry in Clinical Practice: Consensus statements from an expert panel based on evidence. C. E FIFE, D. R. SMART, P. J. SHEFFIELD, H. W. HOPF, G. HAWKINS , D CLARKE , J Undersea and Hyp Med Vol. 36, No. 1 p 43-53, 2009 Values duringO2challenge > 35 mmHg (4.7 kPa) and> 50 % increase compared to valuein air Benefit from hyperbaric oxygen therapy likely
  • 16. Summary tcpO2 •Hear Dr. Caroline Fife summarize the information from this document: http://www.perimed- instruments.com/diagnosing-PAD#tcpo2 Transcutaneous Oximetry in Clinical Practice: Consensus statements from an expert panel based on evidence. C. E FIFE, D. R. SMART, P. J. SHEFFIELD, H. W. HOPF, G. HAWKINS , D CLARKE , J Undersea and Hyp Med Vol. 36, No. 1 p 43-53, 2009
  • 17. ADA American Diabetes Association Comprehensive Foot Examination and Risk Assessment, 2008
  • 18. In patients with diabetes: Vascular assessment to define overall lower extremity risk status Clinical history: Vascular symptoms: Claudication, rest pain, non-healing ulcer. In patients with ABI > 1.3: Toe pressure tcpO2 Note: ABI may be misleading in diabetes because of incompressible arteries resulting in falsely elevated ABI. Vascular foot exam: Palpation of posterior tibialand dorsalispedis In patients with absent pulses or signs/symptoms of vascular disease, In all diabetic patients over 50 years : Ankle-Brachial Index (ABI) Assign foot risk category Apart from vascular status, other parameters such as neurological assessment are included in the risk assessment. ABI < 0.8 claudication ABI < 0.4 tissue necrosis ABI > 0.9 normal
  • 19. TASC II Inter-Society consensus for the Management of Peripheral Arterial Disease, 2007
  • 20. * In addition: PVR, VWF, Duplex imaging *
  • 21. Thank You! Please visitwww.perimed-instruments.com