Recommendation	Grade	Level of evidence	Key references
1. Definitions and nomenclature
1.1	Use objective hemodynamic tests to determine the presence and to quantify the severity of ischemia in all patients with suspected CLTI.	1 (Strong)	C (Low)	de Graaff,16 2003 Brownrigg,17 2016 Wang,18 2016
1.2	Use a lower extremity threatened limb classification staging system (eg, SVS’s WIfI classification system) that grades wound extent, degree of ischemia, and severity of infection to guide clinical management in all patients with suspected CLTI.	1 (Strong)	C (Low)	See Table 1.2 in full guideline.
2. Global epidemiology and risk factors for CLTI
	No recommendations
3. Diagnosis and limb staging in CLTI
3.1	Perform a detailed history to determine symptoms, past medical history, and cardiovascular risk factors in all patients with suspected CLTI.	Good practice statement
3.2	Perform a complete cardiovascular physical examination of all patients with suspected CLTI.	Good practice statement
3.3	Perform a complete examination of the foot, including an assessment of neuropathy and a probe-to-bone test of any open ulcers, in all patients with pedal tissue loss and suspected CLTI.	Good practice statement
3.4	Measure AP and ABI as the first-line noninvasive test in all patients with suspected CLTI.	1 (Strong)	B (Moderate)	Lijmer,19 1996 Dachun,20 2010
3.5	Measure TP and TBI in all patients with suspected CLTI and tissue loss (Fig 3.1 in full guideline).	1 (Strong)	B (Moderate)	Aboyans,21 2008 Salaun,22 2018
3.6	Consider using alternative methods for noninvasive assessment of perfusion, such as PVR, transcutaneous oximetry, or skin perfusion pressure, when ankle and toe pressures, indices, and waveforms cannot be assessed.	2 (Weak)	C (Low)	Aboyans,21 2008 Shirasu,23 2016 Saluan,22 2018
3.7	Consider DUS imaging as the first arterial imaging modality in patients with suspected CLTI.	2 (Weak)	B (Moderate)	Hingorani,24 2008
3.8	Consider noninvasive vascular imaging modalities (DUS, CTA, MRA) when available before invasive catheter angiography in patients with suspected CLTI who are candidates for revascularization.	2 (Weak)	B (Moderate)	Larch,25 1997 Adriaensen,26 2004 Hingorani,27 2004 Collins,28 2007 Hingorani,24 2008 Met,29 2009
3.9	Obtain high-quality angiographic imaging of the lower limb (with modalities and techniques to be determined by local availabilty of facilities and expertise). This should include the ankle and foot in all patients with suspected CLTI who are considered potential candidates for revascularization.	Good practice statement
4. Medical management
4.1	Evaluate cardiovascular risk factors in all patients with suspected CLTI.	1 (Strong)	B (Moderate)	I.C.A.I. Group,30 1997
4.2	Manage all modifiable risk factors to recommended levels in all patients with suspected CLTI.	1 (Strong)	B (Moderate)	Armstrong,31 2014 Faglia,32 2014
4.3	Treat all patients with CLTI with an antiplatelet agent.	1 (Strong)	A (High)	Antithrombotic Trialists’ Collaboration,33 2002 Antithrombotic Trialists’ Collaboration,34 2009
4.4	Consider clopidogrel as the single antiplatelet agent of choice in patients with CLTI.	2 (Weak)	B (Moderate)	CAPRIE,35 1996 Hiatt,36 2017
4.5	Consider low-dose aspirin and rivaroxaban, 2.5 mg twice daily, to reduce adverse cardiovascular events and lower extremity ischemic events in patients with CLTI.	2 (Weak)	B (Moderate)	Anand,37 2018
4.6	Do not use systemic vitamin K antagonists for the treatment of lower extremity atherosclerosis in patients with CLTI.	1 (Strong)	B (Moderate)	Anand,38 2007
4.7	Use moderate- or high-intensity statin therapy to reduce all-cause and cardiovascular mortality in patients with CLTI.	1 (Strong)	A (High)	Leng,39 2000 Heart Protection Study Collaborative Group,40 2002 Meade,41 2002 Aung,42 2007 Mills,43 2011 Rodriguez,44 2017
4.8	Control hypertension to target levels of <140 mm Hg systolic and <90 mm Hg diastolic in patients with CLTI.	1 (Strong)	B (Moderate)	ACCORD Study Group,45 2010 Bavry,46 2010 Wright,47 2015 (SPRINT) Moise,48 2016
4.9	Consider control of type 2 DM in CLTI patients to achieve a hemoglobin A1c of <7% (53 mmol/mol [International Federation of Clinical Chemistry]).	2 (Weak)	B (Moderate)	Selvin,49 2004 Nathan,50 2005 van Dieren,51 2014 Fox,52 2015 American Diabetes Association,53 2018
4.10	Use metformin as the primary hypoglycemic agent in patients with type 2 DM and CLTI.	1 (Strong)	A (High)	Palmer,54 2016
4.11	Consider withholding metformin immediately before and for 24 to 48 hours after the administration of an iodinated contrast agent for diabetic patients, especially those with an estimated glomerular filtration rate <30 mL/min/1.73 m2.	2 (Weak)	C (Low)	Nawaz,55 1998 Goergen,56 2010 Stacul,57 2011
4.12	Offer smoking cessation interventions (pharmacotherapy, counseling, or behavior modification therapy) to all patients with CLTI who smoke or use tobacco products.	1 (Strong)	A (High)	Dagenais,58 2005 Athyros,59 2013 Blomster,60 2016
4.13	Ask all CLTI patients who are smokers or former smokers about status of tobacco use at every visit.	1 (Strong)	A (High)	Kondo,61 2011 Newhall,62 2017
4.14	Prescribe analgesics of appropriate strength for CLTI patients who have ischemic rest pain of the lower extremity and foot until pain resolves after revascularization.	Good practice statement
4.15	In CLTI patients with chronic severe pain, use paracetamol (acetaminophen) in combination with opioids for pain control.	Good practice statement
5. The Global Limb Anatomic Staging System (GLASS) for CLTI
5.1	Use an integrated, limb-based anatomic staging system (such as the GLASS) to define complexity of a preferred target artery path (TAP) and to facilitate evidence-based revascularization (EBR) in patients with CLTI.	Good practice statement
6. Strategies for EBR
6.1	Refer all patients with suspected CLTI to a vascular specialist for consideration of limb salvage, unless major amputation is considered medically urgent.	Good practice statement
6.2	Offer primary amputation or palliation to patients with limited life expectancy, poor functional status (eg, nonambulatory), or an unsalvageable limb after shared decision-making.	Good practice statement
6.3	Estimate periprocedural risk and life expectancy in patients with CLTI who are candidates for revascularization.	1 (Strong)	C (Low)	Biancari,63 2007 Schanzer,64 2008 Bradbury,65 2010 Meltzer,66 2013 Simons,67 2016
6.4	Define a CLTI patient as average surgical risk when anticipated periprocedural mortality is <5% and estimated 2-year survival is >50%.	2 (Weak)	C (Low)
6.5	Define a CLTI patient as high surgical risk when anticipated periprocedural mortality is ≥5% or estimated 2-year survival is ≤50%.	2 (Weak)	C (Low)
6.6	Use an integrated threatened limb classification system (such as WIfI) to stage all CLTI patients who are candidates for limb salvage.	1 (Strong)	C (Low)	Cull,68 2014 Zhan,69 2015 Causey,70 2016 Darling,71 2016 Robinson,72 2017
6.7	Perform urgent surgical drainage and debridement (including minor amputation if needed) and commence antibiotic treatment in all patients with suspected CLTI who present with deep space foot infection or wet gangrene.	Good practice statement
6.8	Repeat limb staging after surgical drainage, debridement, minor amputations, or correction of inflow disease (AI, common and deep femoral artery disease) and before the next major treatment decision.	Good practice statement
6.9	Do not perform revascularization in the absence of significant ischemia (WIfI ischemia grade 0) unless an isolated region of poor perfusion in conjunction with major tissue loss (eg, WIfI wound grade 2 or3) can be effectively targeted and the wound progresses or fails to reduce in size by ≥50% within 4 weeks despite appropriate infection control, wound care, and offloading.	Good practice statement
6.10	Do not perform revascularization in very-low-risk limbs (eg, WIfI stage 1) unless the wound progresses or fails to reduce in size by ≥50% within 4 weeks despite appropriate infection control, wound care, and offloading.	2 (Weak)	C (Low)	Sheehan,73 2003 Cardinal,74 2008 Lavery,75 2008 Snyder,76 2010
6.11	Offer revascularization to all average-risk patients with advanced limb-threatening conditions (eg, WIfI stage 4) and significant perfusion deficits (eg, WIfI ischemia grades 2 and 3).	1 (Strong)	C (Low)	Abu Dabrh,5 2015
6.12	Consider revascularization for average-risk patients with intermediate limb threat (eg, WIfI stages 2 and 3) and significant perfusion deficits (eg, WIfI ischemia grades 2 and 3).	2 (Weak)	C (Low)	Zhan,69 2015 Causey,70 2016 Darling,71 2016 Robinson,72 2017
6.13	Consider revascularization in average-risk patients with advanced limb threat (eg, WIfI stage 4) and moderate ischemia (eg, WIfI ischemia grade 1).	2 (Weak)	C (Low)
6.14	Consider revascularization in average-risk patients with intermediate limb threat (eg, WIfI stages 2 and 3) and moderate ischemia (eg, WIfI ischemia grade 1) if the wound progresses or fails to reduce in size by ≥50% within 4 weeks despite appropriate infection control, wound care, and offloading.	2 (Weak)	C (Low)
6.15	Obtain high-quality angiographic imaging with dedicated views of ankle and foot arteries to permit anatomic staging and procedural planning in all CLTI patients who are candidates for revascularization.	Good practice statement
6.16	Use an integrated limb-based staging system (eg, GLASS) to define the anatomic pattern of disease and preferred TAP in all CLTI patients who are candidates for revascularization.	Good practice statement
6.17	Perform ultrasound vein mapping when available in all CLTI patients who are candidates for surgical bypass.	1 (Strong)	C (Low)	Seeger,77 1987 Wengerter,78 1990 Schanzer,79 2007
6.18	Map the ipsilateral GSV and small saphenous vein for planning of surgical bypass. Map veins in the contralateral leg and both arms if ipsilateral vein is insufficient or inadequate.	Good practice statement
6.19	Do not classify a CLTI patient as being unsuitable for revascularization without review of adequate-quality imaging studies and clinical evaluation by a qualified vascular specialist.	Good practice statement
6.20	Correct inflow disease first when both inflow and outflow disease are present in a patient with CLTI.	Good practice statement
6.21	Base the decision for staged vs combined inflow and outflow revascularization on patient risk and the severity of limb threat (eg, WIfI stage).	1 (Strong)	C (Low)	Harward,80 1995 Zukauskas,81 1995
6.22	Correct inflow disease alone in CLTI patients with multilevel disease and low-grade ischemia (eg, WIfI ischemia grade 1) or limited tissue loss (eg, WIfI wound grade 0/1) and in any circumstance in which the risk-benefit of additional outflow reconstruction is high or initially unclear.	1 (Strong)	C (Low)
6.23	Restage the limb and repeat the hemodynamic assessment after performing inflow correction in CLTI patients with inflow and outflow disease.	1 (Strong)	C (Low)
6.24	Consider simultaneous inflow and outflow revascularization in CLTI patients with a high limb risk (eg, WIfI stages 3 and 4), or in patients with severe ischemia (eg, WIfI ischemia grades 2 and 3).	2 (Weak)	C (Low)
6.25	Use an endovascular-first approach for treatment of CLTI patients with moderate to severe (eg, GLASS stage IA) aorto-iliac (AI) disease, depending on the history of prior intervention.	1 (Strong)	B (Moderate)	Jongkind,82 2010 Ye,83 2011 Deloose,84 2017
6.26	Consider surgical reconstruction for the treatment of average-risk CLTI patients with extensive (eg, GLASS stage II) AI disease or after failed endovascular intervention.	2 (Weak)	C (Low)	Ricco,85 2008 Chiu,86 2010 Indes,87 2013
6.27	Perform open CFA endarterectomy with patch angioplasty, with or without extension into the PFA, in CLTI patients with hemodynamically significant (>50% stenosis) disease of the common and deep femoral arteries.	1 (Strong)	C (Low)	Kang,88 2008 Ballotta,89 2010
6.28	Consider a hybrid procedure combining open CFA endarterectomy and endovascular treatment of AI disease with concomitant CFA involvement (GLASS stage IB).	2 (Weak)	C (Low)	Chang,90 2008
6.29	Consider endovascular treatment of significant CFA disease in selected patients who are deemed to be at high surgical risk or to have a hostile groin.	2 (Weak)	C (Low)	Baumann,91 2011 Bonvini,92 2011 Gouëffic,93 2017 Siracuse,94 2017
6.30	Avoid stents in the CFA and do not place stents across the origin of a patent deep femoral artery.	Good practice statement
6.31	Correct hemodynamically significant (≥50% stenosis) disease of the proximal deep femoral artery whenever technically feasible.	Good practice statement
6.32	In average-risk CLTI patients with infrainguinal disease, base decisions of endovascular intervention vs open surgical bypass on the severity of limb threat (eg, WIfI), the anatomic pattern of disease (eg, GLASS), and the availability of autologous vein.	1 (Strong)	C (Low)	Almasri,7 2018
6.33	Offer endovascular revascularization when technically feasible for high-risk patients with advanced limb threat (eg, WIfI stage 4) and significant perfusion deficits (eg, WIfI ischemia grades 2 and 3).	2 (Weak)	C (Low)	Abu Dabrh,5 2015 Zhan,69 2015 Causey,70 2016 Darling,71 2016 Robinson,72 2017
6.34	Consider endovascular revascularization for high-risk patients with intermediate limb threat (eg, WIfI stages 2 and 3) and significant perfusion deficits (eg, WIfI ischemia grades 2 and 3).	2 (Weak)	C (Low)
6.35	Consider endovascular revascularization for high-risk patients with advanced limb threat (eg, WIfI stage 4) and moderate ischemia (eg, WIfI ischemia grade 1) if the wound progresses or fails to reduce in size by ≥50% within 4 weeks despite appropriate infection control, wound care, and offloading, when technically feasible.	2 (Weak)	C (Low)
6.36	Consider endovascular revascularization for high-risk patients with intermediate limb threat (eg, WIfI stages 2 and 3) and moderate ischemia (eg, WIfI ischemia grade 1) if the wound progresses or fails to reduce in size by ≥50% within 4 weeks despite appropriate infection control, wound care, and offloading, when technically feasible.	2 (Weak)	C (Low)
6.37	Consider open surgery in selected high-risk patients with advanced limb threat (eg, WIfI stage 3 or 4), significant perfusion deficits (ischemia grade 2 or 3), and advanced complexity of disease (eg, GLASS stage III) or after prior failed endovascular attempts and unresolved symptoms of CLTI.	2 (Weak)	C (Low)
6.38	Consider angiosome-guided revascularization in patients with significant wounds (eg, WIfI wound grades 3 and 4), particularly those involving the midfoot or hindfoot, and when the appropriate TAP is available.	2 (Weak)	C (Low)	Azuma,95 2012 Sumpio,96 2013 Biancari,97 2014 Chae,98 2016 Jongsma,99 2017
6.39	In treating femoro-popliteal (FP) disease in CLTI patients by endovascular means, consider adjuncts to balloon angioplasty (eg, stents, covered stents, or drug-eluting technologies) when there is a technically inadequate result (residual stenosis or flow-limiting dissection) or in the setting of advanced lesion complexity (eg, GLASS FP grade 2–4).	2 (Weak)	B (Moderate)	Schillinger,100 2006 Saxon,101 2008 Dake,102 2011 Rosenfield,103 2015 Almasri,7 2018
6.40	Use autologous vein as the preferred conduit for infrainguinal bypass surgery in CLTI.	1 (Strong)	B (Moderate)	Almasri,7 2018
6.41	Avoid using a nonautologous conduit for infrainguinal bypass unless there is no endovascular option and no adequate autologous vein.	2 (Weak)	C (Low)	Almasri,7 2018
6.42	Perform intraoperative imaging (angiography, DUS, or both) on completion of open bypass surgery for CLTI and correct significant technical defects if feasible during the index operation.	1 (Strong)	C (Low)	Mills,104 1992 Bandyk,105 1994
7. Nonrevascularization treatments of the limb
7.1	Consider spinal cord stimulation to reduce the risk of amputation and to decrease pain in carefully selected patients (eg, rest pain, minor tissue loss) in whom revascularization is not possible.	2 (Weak)	B (Moderate)	Ubbink,106 2013
7.2	Do not use lumbar sympathectomy for limb salvage in CLTI patients in whom revascularization is not possible.	2 (Weak)	C (Low)	Karanth,107 2016
7.3	Consider intermittent pneumatic compression therapy in carefully selected patients (eg, rest pain, minor tissue loss) in whom revascularization is not possible.	2 (Weak)	B (Moderate)	Abu Dabrh,4 2015
7.4	Do not offer prostanoids for limb salvage in CLTI patients. Consider offering selectively for patients with rest pain or minor tissue loss and in whom revascularization is not possible.	2 (Weak)	B (Moderate)	Vietto,108 2018
7.5	Do not offer vasoactive drugs or defibrinating agents (ancrod) in patients in whom revascularization is not possible.	1 (Strong)	C (Low)	Smith,109 2012
7.6	Do not offer HBOT to improve limb salvage in CLTI patients with severe, uncorrected ischemia (eg, WIfI ischemia grade 2/3).	1 (Strong)	B (Moderate)	Kranke,110 2015 Game,111 2016 Santema,112 2018
7.7	Continue to provide optimal wound care until the lower extremity wound is completely healed or the patient undergoes amputation.	Good practice statement
8. Biologic and regenerative medicine approaches in CLTI
8.1	Restrict use of therapeutic angiogenesis to CLTI patients who are enrolled in a registered clinical trial.	1 (Strong)	B (Moderate)	Abu Dabrh,4 2015 Peeters,113 2015
9. The role of minor and major amputations
9.1	Consider transmetatarsal amputation of the forefoot in CLTI patients who would require more than two digital ray amputations to resolve distal necrosis, especially when the hallux is involved.	2 (Weak)	C (Low)	Elsherif,114 2018
9.2	Offer primary amputation to CLTI patients who have a pre-existing dysfunctional or unsalvageable limb, a poor functional status (eg, bedridden), or a short life expectancy after shared decision-making with the patient and health care team.	1 (Strong)	C (Low)	Aziz,115 2015 Siracuse,116 2015
9.3	Consider secondary amputation for patients with CLTI who have a failed or ineffective reconstruction and in whom no further revascularization is possible and who have incapacitating pain, nonhealing wounds, or uncontrolled sepsis in the affected limb after shared decision-making with the patient and health care team.	2 (Weak)	C (Low)	Reed,117 2008
9.4	Consider revascularization to improve the possibility of healing an amputation at a more distal functional amputation level (eg, AKA to BKA), particularly for patients with a high likelihood of rehabilitation and continued ambulation.	2 (Weak)	C (Low)	Rollins,118 1985 Miksic,119 1986
9.5	Consider a TKA or AKA in patients who are nonambulatory for reasons other than CLTI (ie, bedridden patients with flexion contracture, dense hemiplegia, cancer) and are unlikely to undergo successful rehabilitation to ambulation.	2 (Weak)	C (Low)	Ayoub,120 1993 Taylor,121 2008
9.6	Involve a multidisciplinary rehabilitation team from the time a decision to amputate has been made until successful completion of rehabilitation has been achieved.	1 (Strong)	C (Low)	Webster,122 2012
9.7	Continue to observe CLTI patients who have undergone amputation at least yearly to monitor progression of disease in the contralateral limb and to maintain optimal medical therapy and risk factor management.	1 (Strong)	C (Low)	Bradley,123 2006 Glaser,124 2013
10. Postprocedural care and surveillance after infrainguinal revascularization for CLTI
10.1	Continue best medical therapy for PAD, including the long-term use of antiplatelet and statin therapies, in all patients who have undergone lower extremity revascularization.	1 (Strong)	A (High)	Abbruzzese,125 2004 Henke,126 2004 Brown,127 2008 Bedenis,128 2015 Suckow,129 2015
10.2	Promote smoking cessation in all CLTI patients who have undergone lower extremity revascularization.	1 (Strong)	A (High)	Hobbs,130 2003 Willigendael,131 2005
10.3	Consider DAPT (aspirin plus clopidogrel) in patients who have undergone infrainguinal prosthetic bypass for CLTI for a period of 6 to 24 months to maintain graft patency.	2 (Weak)	B (Moderate)	Brown,127 2008 Belch,132 2010 Gassman,133 2014 Bedenis,128 2015
10.4	Consider DAPT (aspirin plus clopidogrel) in patients who have undergone infrainguinal endovascular interventions for CLTI for a period of at least 1 month.	2 (Weak)	C (Low)	Cassar,134 2005 Bhatt,135 2006 Tepe,136 2012 Strobl,137 2013
10.5	Consider DAPT for a period of 1 to 6 months in patients undergoing repeated catheter-based interventions if they are at low risk for bleeding.	2 (Weak)	C (Low)	Cassar,134 2005 Tepe,136 2012 Strobl,137 2013
10.6	Observe patients who have undergone lower extremity vein bypass for CLTI on a regular basis for at least 2 years with a clinical surveillance program consisting of interval history, pulse examination, and measurement of resting APs and TPs. Consider DUS scanning where available.	Good practice statement
10.7	Observe patients who have undergone lower extremity prosthetic bypass for CLTI on a regular basis for at least 2 years with interval history, pulse examination, and measurement of resting APs and TPs.	Good practice statement
10.8	Observe patients who have undergone infrainguinal endovascular interventions for CLTI in a surveillance program that includes clinical visits, pulse examination, and noninvasive testing (resting APs and TPs).	Good practice statement
10.9	Consider performing additional imaging in patients with lower extremity vein grafts who have a decrease in ABI ≥0.15 and recurrence of symptoms or change in pulse status to detect vein graft stenosis.	Good practice statement
10.10	Offer intervention for DUS-detected vein graft lesions with an associated PSV of >300 cm/s and a PSV ratio >3.5 or grafts with low velocity (midgraft PSV <45 cm/s) to maintain patency.	1 (Strong)	B (Moderate)	Mills,138 2001
10.11	Maintain long-term surveillance after surgical or catheter-based revision of a vein graft, including DUS graft scanning where available, to detect recurrent graft-threatening lesions.	1 (Strong)	B (Moderate)	Landry,139 2002 Nguyen,140 2004
10.12	Consider arterial imaging after endovascular intervention for failure to improve (wound healing, rest pain) or a recurrence of symptoms to detect restenosis or progression of pre-existing disease.	2 (Weak)	C (Low)	Bui,141 2012
10.13	Consider reintervention for patients with DUS-detected restenosis lesions >70% (PSV ratio >3.5, PSV >300 cm/s) if symptoms of CLTI are unresolved or on a selective basis in asymptomatic patients after catheter-based interventions.	2 (Weak)	C (Low)	Humphries,142 2011
10.14	Provide mechanical offloading as a primary component for care of all CLTI patients with pedal wounds.	1 (Strong)	A (High)	Elraiyah,143 2016
10.15	Provide counseling on continued protection of the healed wound and foot to include appropriate shoes, insoles, and monitoring of inflammation.	1 (Strong)	A (High)	Elraiyah,143 2016
11. Study designs and trial end points in CLTI
11.1	Use a research framework such as the IDEAL for gathering new data and evidence on the surgical and endovascular management of CLTI.
11.2	Encourage funders, journal reviewers, and editors to prioritize prospective, multicenter, controlled, and preferably randomized studies over retrospective case series, studies using historical controls, or other less rigorous research methodologies.
11.3	When RCTs are not feasible, use the OPG benchmarks from the SVS’s Critical Limb Ischemia Working Group to evaluate the efficacy of novel endovascular CLTI techniques and devices.
11.4	To facilitate sufficient enrollment, limit RCT exclusion criteria to those who are deemed essential to trial integrity.
11.5	Design RCTs, prospective cohort studies, and registries that are specific to CLTI.
11.6	Use an integrated, limb-based threatened limb classification system (eg, WIfI) and a whole limb anatomic classification scheme (eg, GLASS) to describe the characteristics and outcomes of CLTI patients who are enrolled.
11.7	Describe outcomes in CLTI trials using a combination of objective and clinically relevant events, subjective PROMs and HRQL assessments, and anatomic and hemodynamic end points.
11.8	Require regulatory trials aimed at obtaining premarket approval for devices for use in CLTI to study CLTI patients and to present data on objective and clinically relevant end points, PROMs and HRQL assessments, and anatomic and hemodynamic end points.
11.9	Follow up patients in trials for a time sufficient (this will usually be >2 years) to allow appropriate comparison of the impact of the different interventions on the natural history of CLTI. Measure and declare completeness of follow-up coverage to quantify risk of attrition bias.
11.10	Include a time-integrated measure of clinical disease severity (such as freedom from CLTI) in the CLTI trial design to describe the total impact of comparator CLTI interventions.
11.11	Publish all CLTI trial protocols together with the full statistical analysis plans in peer-reviewed journals to allow independent, public, and transparent scrutiny and to prevent nonreporting of negative trials.
11.12	Conduct postmarketing surveillance data collection using well-designed, large observational studies and registries.
11.13	Share clinical trial data to allow subsequent individual patient data analyses, meta-analyses, and subgroup analyses; updating of OPGs; and validation of decision-making tools, such as the WIfI system and GLASS.
11.14	Assess the quality of evidence in CLTI research using frameworks such as GRADE that consider multiple certainty domains and are not based solely on study design.
12. Creating a Center of Excellence for amputation prevention
	No recommendations

ABI, Ankle-brachial index; AI, aortoiliac; AKA, above-knee amputation; AP, ankle pressure; BKA, below-knee amputation; CFA, common femoral artery; CLTI, chronic limb-threatening ischemia; CTA, computed tomography angiography; DAPT, dual antiplatelet therapy; DM, diabetes mellitus; DUS, duplex ultrasound; EBR, evidence-based revascularization; FP, femoropopliteal disease; GLASS, Global Limb Anatomic Staging System; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; GSV, great saphenous vein; HBOT, hyperbaric oxygen therapy; HRQL, health-related quality of life; IDEAL, Idea, Development, Exploration, Assessment, and Long-term study; IPC, intermittent pneumatic compression; LS, lumbar sympathectomy; MRA, magnetic resonance angiography; OPGs, objective performance goals; PAD, peripheral artery disease; PFA, profunda femoris artery; PROMs, patient-reported outcomes measures; PSV, peak systolic velocity; PVR, pulse volume recording; RCTs, randomized controlled trials; SCS, spinal cord stimulation; SVS, Society for Vascular Surgery; TAP, target arterial path; TBI, toe-brachial index; TKA, through-knee amputation; TP, toe pressure; WIfI, Wound, Ischemia, and foot Infection.