Health Problem: Chronic wounds are those that fail to heal with at least 30 days of optimized standard wound therapy, which usually includes cleaning, debridement, infection control, dressing, and offloading. Poor circulation is a common cause across etiologies, including diabetes. Chronic foot ulcers in people with diabetes may occur when foot injuries, such as cuts, blisters, or sores, develop, worsen, and do not heal. Sequelae can include poor healing of wounds, particularly on the feet, which can lead to amputation. Reasons are multifactorial and may include compromised sensation due to diabetes-related nerve damage and poor blood flow due to diabetes-related blood vessel damage.

Technology Description: There are 2 types of topical oxygen therapy (TOT), both of which are intended to improve wound oxygenation and promote healing by delivering oxygen to the wound area:

  • Hyperbaric topical oxygen therapy (HTOT) is the original mode of administering TOT. During a clinical appointment, the affected limb is enclosed in a chamber or gas-impermeable bag, and the chamber is filled with oxygen pressurized slightly above atmospheric pressure. HTOT requires patient immobility during in-clinic treatment sessions, which may last 90 minutes once per day for weeks.
  • Continuous topical oxygen therapy (CTOT) is a newer alternative to HTOT that does not require patient immobilization or in-clinic administration and can be used at the same time as dressings and offloading. A portable oxygen concentrator refines and delivers atmospheric (normobaric) oxygen to the wound site through a cannula.

Controversy: TOT’s potential for oxygenating wounds has been questioned, since the amount of oxygen absorbed through intact skin is very small, and TOT’s ability to perfuse oxygen through the wound is limited and may even be diminished in a pressurized environment (i.e., HTOT).

Key Questions:

For the treatment of chronic wounds:

  • Compared with standard wound care alone, what is the efficacy of TOT in terms of amputation incidence, proportion of patients with complete wound healing, time to complete healing, and quality of life (QOL)?
  • What complications are associated with TOT?
  • Have definitive patient selection criteria been established for TOT?

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