Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia　― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ―

Abstract

Background: Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revascularization to prevent limb loss in CLTI patients. The aim of the HOTFOOT study is to examine the impact of HBOT on wound healing in CLTI patients after successful endovascular therapy (EVT). Methods and Results:The HOTFOOT study is a multicenter prospective randomized open blinded-endpoint trial that is to be conducted at 10 trial centers in Japan between February 2021 and February 2022. This study will enroll 140 patients with CLTI receiving successful EVT. Eligible participants will be allocated 1 : 1 to either the EVT+HBOT or EVT group; participants in the EVT+HBOT group will receive 30 HBOT sessions. The primary outcome is the time to complete wound healing over the 6-month follow-up. Secondary outcomes during the 6-month follow-up are the proportion of patients who achieved complete wound healing, freedom from major lower-limb amputation, amputation-free survival, and freedom from target lesion reintervention. Conclusions:This study is expects to assess whether HBOT, in combination with successful EVT, can improve lower-limb outcomes in CLTI patients.

Effectiveness of Repetitive Hyperbaric Oxygen Therapy for Chronic Limb-Threatening Ischemia

“…Despite the initiation of a registry study in Japan 17 , the number of effective treatments, dropout rates, and patient selection by indication have not been clarified.…”

Orbital Onslaught: An Atypical Presentation of Mucormycosis in a Diabetic and Hypertensive Patient

“…The protocol for HBOT can vary but typically involves multiple sessions or 'dives' in the hyperbaric chamber, each lasting about 90 to 120 minutes. The total number of sessions might range from 20 to 40 or more, spread over several weeks, depending on the severity of the infection and the patient's health status [10]. This treatment option was explored to enhance our comprehensive management strategy, considering its potential to deter fungal proliferation and support tissue healing.…”