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CLINICAL STATEMENTS AND GUIDELINES

June 11, 2024 Circulation. 2024;149:e1313–e1410. DOI: 10.1161/CIR.0000000000001251 e1364

of complete wound healing and a functional limb (Table 17). One study showed a limb salvage rate of 100% at 3 years in a cohort of patients with CLTI who achieved complete wound healing with endovascular revascularization followed by dedicated wound care.6 Repeated wound assessment during follow-up allows for close evaluation of the nature of the wound to help determine the best local wound care, identify signs of biofilm or infection, and allow for frequent debridement.7,17–20 Debridement techniques include: surgical, sharp/ conservative-sharp, autolytic, mechanical, enzymatic, chemical/mechanical/surfactant, and biosurgical/larval methods.21 Specifics regarding the approach to local wound care are highly variable and depend on the status and location of the wound. Particularly among patients with diabetes, the pathophysiological mechanisms of nonhealing wounds are complex and multifactorial and include neuropathy, infection, ischemia, and abnormal foot biomechanics and structure. In general, wound dressing products should be used to maintain a moist wound bed while controlling any drainage and exudate and avoiding tissue maceration. Some wound care products also help manage biofilm. Optimizing the wound-healing environment also includes medical optimization, such as smoking cessation, good glycemic control, cardiovascular risk factor modification, and nutrition. Thus, management of these patients is optimal when delivered by a multispecialty care team. Adjunctive wound care therapies including NPWT and biologics (eg, topical cytokine ointments, skin substitutes, cell-based therapies intended to optimize wound healing) are often considered when wounds do not heal or progress after standard wound care. To date, no RCTs or high-quality studies have focused on wound-healing adjuncts in such patients other than NPWT wound therapy. Limited data have shown the efficacy of NPWT as an adjunctive therapy for treatment of nonhealing wounds (eg, diabetic foot ulcers, CLTI wounds).8–10 Updated international consensus guidelines on wound care therapies have been recently published.21

3 Numerous studies of various sizes, including some

RCTs and some meta-analyses, have evaluated the impact of hyperbaric oxygen therapy on limb salvage and wound healing. Variability in terms of methodology, types of wounds, and presence of ischemia exists. Many of the studies focused on limb salvage for diabetic foot ulcers, without evidence of severe PAD. One small RCT that focused on patients with foot ulcers and PAD (ABI <0.80 or TBI <0.70), for whom no revascularization was planned, showed a significant decrease in ulcer area at 6 weeks, but no significant differences in ulcer size at 6 months, complete ulcer healing at 6 weeks or 6 months, and major or minor amputations.11 In a slightly larger study that included 70 patients with severely ischemic foot ulcers, the amputation rate was 9% in the treatment group and 33% in the control group.12 However, in a larger longitudinal study of diabetic foot ulcers, the use of hyperbaric oxygen therapy did not result in better wound healing.13 A recent systematic review and meta-analysis of hyperbaric oxygen therapy for diabetic foot ulcers reported reduction in major amputation with hyperbaric oxygen therapy, although no reduction in minor amputation or overall mortality.14 Hyperbaric oxygen therapy may be considered as an adjunctive therapy to revascularization for wound healing in the context of CLTI and diabetic foot ulcers.

10.3.3 Approach to the “No Option” Patient With CLTI

Recommendations for Approach to the “No Option” Patient With CLTI Referenced studies that support the recommendations are summarized in the Online Data Supplement. COR LOE Recommendations

2b B-R 1 In patients with CLTI for whom revascularization is

not an option and a lack of outflow to the foot is observed, the usefulness of prostanoids is uncertain.1–3

2b B-NR 2 In patients with CLTI for whom revascularization is

not an option, arterial intermittent pneumatic compression devices may be considered to augment wound healing or ameliorate ischemic rest pain.4–7

2b B-NR 3 In patients with CLTI for whom arterial

revascularization is not an option and a lack of outflow to the foot is observed, venous arterialization may be considered for limb preservation.8–12

Synopsis CLTI is a severe manifestation of PAD. Within this heterogenous patient population are those with no options for revascularization after evaluation by a multispecialty care

Table 17.  Components of Wound Care for Patients With CLTI Revascularization for adequate perfusion (see Section 10.2, “Revascularization for CLTI”) Debridement of nonviable tissue Management of infection, inflammation, or both Pressure offloading, when appropriate (see Section 10.3.1, “Pressure Offloading for CLTI”) Maintaining conducive wound-healing environment (ie, local wound care, dressings) (see Section 10.3.2, “Wound Care and Management of Infection for CLTI”) Pain control Medical optimization of host factors (eg, smoking cessation, glycemic control) (see Section 5, “Medical Therapy and Preventive Foot Care for Patients with PAD”) Optimization of tissue growth Control of edema CLTI indicates chronic limb-threatening ischemia; PAD, peripheral artery disease.

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