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CLINICAL STATEMENTS AND GUIDELINES Circulation. 2024;149:e1313–e1410. DOI: 10.1161/CIR.0000000000001251 June 11, 2024 e1363 Recommendation-Specific Supportive Text 1 Multiple randomized and nonrandomized studies have shown the superiority of nonremovable over removable pressure offloading devices for wound healing in the setting of diabetic foot ulcers.2,6–9 Forefoot pressure offloading shoes or cast shoes have also been shown in several nonrandomized studies to be effective in promoting wound healing.1–5 A significant percentage of patients with diabetic foot ulcers have PAD; therefore, these data are applicable to the population with CLTI.13 2 At least 2 well-conducted RCTs have shown that effective pressure offloading footwear reduces the risk of recurrent plantar ulcers in patients with diabetes.10 In a randomized trial, subjects were treated with foot shape- and barefoot pressure-based orthoses versus standard of care for 15 months.10 Compared with standard of care, these customized orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence but only if worn as prescribed.10,11 In another RCT,11 171 patients with diabetic neuropathy and previous foot ulcer were randomized to custom-made footwear with improved and sustained pressure offloading or to usual care. In individuals with high adherence, custom-made footwear was associated with lower plantar foot ulcer recurrence at 18 months. In an RCT comparing 3 different pressure offloading devices, patients with diabetic plantar foot ulcers who were randomized to total-contact cast had a higher and faster rate of wound healing than those randomized to a half-shoe or to a removable cast walker.12 3 By far, most research on the efficacy of pressure offloading has been conducted in patients with diabetic foot ulcers, where peripheral neuropathy is a common occurrence. The effectiveness of pressure offloading in patients with foot ulcers without diabetes is unknown. However, proper pressure offloading may be beneficial in allowing tissue growth and wound healing and may be considered in patients with CLTI and foot ulcers who do not have diabetes. Proper pressure offloading is individually tailored to minimize excessive or persistent pressure at the site of the foot ulcer. 10.3.2 Wound Care and Management of Infection for CLTI Recommendations for Wound Care and Management of Infection for CLTI Referenced studies that support the recommendations are summarized in the Online Data Supplement. COR LOE Recommendations 1 B-NR 1 In patients with CLTI, prompt management of foot infection with antibiotics, debridement, and other surgical management is recommended.1–5 1 C-LD 2. In patients with CLTI with nonhealing wounds, wound care should be provided to optimize the wound-healing environment after revascularization with the goal of complete wound healing.6–10 2b B-NR 3 In patients with CLTI with nonhealing diabetic foot ulcers, hyperbaric oxygen therapy may be considered to assist in wound healing after revascularization.11–14 Synopsis Management of infection and local wound care are a critical component to the care of patients with CLTI and must be implemented concurrently with revascularization (Figures 6 and 7). The multispecialty care team for CLTI should include expertise in developing a wound care plan along with its implementation. Components of wound care in CLTI are outlined in Table 17. Beyond wound care, hyperbaric oxygen therapy has been studied in the context of wound healing for CLTI as an adjunctive therapy to revascularization and may have a limited role in this population. Recommendation-Specific Supportive Text 1 Foot infection, particularly among patients with diabetes, can progress rapidly, and thus, prompt diagnosis and initiation of therapy, including antibiotics and often surgical management, are key to reducing the high probability of both amputation and death.15 Patients with CLTI should be promptly evaluated and treated to prevent infections with resistant microorganisms and amputation.16 Surgical debridement is recommended for foot infections involving abscess, gas, or necrotizing fasciitis. After successful revascularization, most patients with gangrene of the foot are evaluated for minor amputation with staged or delayed primary closure or surgical reconstruction when feasible.1–3 Negative pressure wound therapy (NPWT), which applies vacuum suction to a wound dressing, can be used to achieve wound healing after revascularization and minor (ie, digit or partial foot) amputation when primary or delayed secondary closure is not feasible.4,5,8 Of note, studies of the efficacy of NPWT have focused primarily on patients with diabetes with very limited data in the patient population without diabetes. For patients with uncomplicated osteomyelitis, one can consider treating primarily with antibiotics. 2. The management of patients with CLTI and non- healing wounds should include coordinated multidisciplinary efforts for both revascularization and evidence-based wound care with the goal Recommendations for Wound Care and Management of Infection for CLTI (Continued) COR LOE Recommendations Downloaded from http://ahajournals.org by on October 7, 2026