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. 2017 May 12;17(5):1–142.

Table 12:

Variations and Limitations Across Included Studies

Author, Year Limitations and Variations
Faglia et al, 199630
  • Multiplace hyperbaric chamber at 2.5 ATA in the first phase and 2.2–2.4 ATA in the second phase

  • Patients started as inpatients, so diabetes management is likely to have been better enforced than in studies with patients receiving treatment only as outpatients

  • Met standard wound care guideline requirements (vascular assessment, offloading, infection control, debridement, and dressing changes)

  • Most patients had about 40 HBOT sessions

  • No follow-up time specified

Kalani et al, 200234
  • Monoplace hyperbaric chamber at 2.5 ATA 5 times a week

  • Nonrandomized, which caused significant differences between groups (age, ID vs. NID, ulcer size)

  • Standard care consisted of assessment and offloading

  • Most patients received 60 HBOT treatments

  • No details of what treatment participants received for 2.5 years after HBOT treatments were finished

  • Follow-up was 3 years

Abidia et al, 200328
  • Multiplace hyperbaric chamber at 2.4 ATA 5 times a week

  • All patients (except one) had Wagner grade 2 ulcers

  • Met standard wound care guideline requirements (vascular assessment, offloading, infection control, debridement, and dressing changes)

  • Patients received 30 HBOT sessions

  • 3 patients had chronic obstructive pulmonary disease (a contraindication for HBOT)

  • Small sample (8 patients in each arm)

  • Follow-up was 1 year

Kessler et al, 200331
  • Multiplace hyperbaric chamber at 2.5 ATA; 2 sessions daily, 5 times a week

  • Patients started as inpatients, so diabetes management is likely to have been better enforced than in studies with patients receiving treatment only as outpatients

  • All patients received 20 HBOT sessions

  • Very few baseline characteristics reported

  • Standard care consisted of infection control and offloading

  • Small sample (14 and 13 patients in each arm)

  • Follow-up was 1 month

Duzgun et al, 200829
  • Monoplace hyperbaric chamber at 2.0 ATA; 2 sessions one day, followed by 1 session the following day (alternating)

  • Standard care consisted of infection control, debridement, and dressing changes

  • Authors did not distinguish patients whose ulcers were a result of ischemia from those whose ulcers were a result of ischemia and prolonged pressure that went undetected owing to neuropathy

  • Outcomes assessed were inconsistent with those assessed in other studies (wound closure through amputation, graft or flap closure, or surgical intervention); further, the study did not identify which patients achieved ulcer closure via each method

  • Defined a minor amputation as either distal or proximal to the metatarsophalangeal joint

  • No follow-up time specified

Londahl et al, 201032
  • Multiplace hyperbaric chamber at 2.5 ATA 5 times a week

  • All patients had 40 HBOT sessions over a span of up to 10 weeks

  • Met standard wound care guideline requirements (vascular assessment, offloading, infection control, and debridement)

  • Follow-up was 1 year

Fedorko et al, 201635
  • Monoplace hyperbaric chamber at 2.4 ATA five times a week

  • All patients had about 27 HBOT sessions

  • Standard care consisted of offloading, infection control, and debridement

  • “Prescription for offloading” given, but study did not indicate how many patients fulfilled prescription

  • Did not measure major amputation; used another outcome: “having met criteria for amputation”

  • Follow-up was 3 months

Abbreviations: ATA, atmospheres absolute; HBOT, hyperbaric oxygen therapy; ID, insulin dependent; NID, not insulin dependent.