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Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening

Yusuke Sato1, Kazushi Urasawa1, Tetsuji Morishita2

  • 1Cardiovascular Center, Tokeidai Memorial Hospital Sapporo Japan.

Circulation Reports
|December 24, 2021
PubMed

Insights

Hyperbaric oxygen therapy (HBOT) combined with endovascular therapy (EVT) may improve wound healing in chronic limb-threatening ischemia (CLTI) patients. This study investigates HBOT

Area of Science:

  • Vascular Surgery
  • Hyperbaric Medicine
  • Regenerative Medicine

Background:

  • Chronic limb-threatening ischemia (CLTI) poses a significant risk of lower-limb amputation.
  • Hyperbaric oxygen therapy (HBOT) is an adjunctive treatment option for CLTI.
  • Current guidelines recommend HBOT alongside, not instead of, revascularization for CLTI.

Purpose of the Study:

  • To evaluate the efficacy of HBOT when added to successful endovascular therapy (EVT) in CLTI patients.
  • To assess the impact of HBOT on wound healing and limb salvage in CLTI.
  • To determine if HBOT improves outcomes after EVT for CLTI.

Main Methods:

  • A multicenter prospective randomized open blinded-endpoint trial (HOTFOOT study).
  • 140 CLTI patients undergoing successful EVT will be randomized 1:1 to EVT+HBOT or EVT alone.
  • Participants will receive 30 HBOT sessions over a 6-month follow-up period.

Main Results:

  • Primary outcome: time to complete wound healing.
  • Secondary outcomes: proportion of complete wound healing, freedom from major amputation, amputation-free survival, and target lesion reintervention.
  • Data collection and analysis will occur over a 6-month follow-up period.

Conclusions:

  • The study aims to determine if combining HBOT with EVT enhances lower-limb outcomes in CLTI patients.
  • Findings will inform clinical practice regarding the use of HBOT as an adjunct therapy for CLTI.
  • This research is expected to provide evidence on the role of HBOT in improving wound healing and preventing amputation in CLTI.

Keywords:
Chronic limb-threatening ischemiaEndovascular treatmentHyperbaric oxygen therapyPeripheral artery diseaseRandomized controlled trial

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