OBJECTIVE - To document peer-reviewed medical publications that have report
ed on hyperbaric oxygen (HBO) therapy as an adjunct to standard lower-extre
mity wound care. Focusing on publications dealing with the diabetic foot.
RESEARCH DESIGN AND METHODS - A review of the medical literature was conduc
ted using MEDLINE. Research articles involving HBO treatment and the diabet
ic foot were critiqued to identify factors that may have been a source of b
ias.
RESULTS - Of the published reports on human studies, seven involved diabete
s-related foot pathology. Five of these studies, two of which were randomiz
ed, included a control group that did not receive HBO therapy. The controll
ed diabetic foot studies included an average of 28 subjects in the HBO ther
apy group (range 10-62) and an average of 16.2 subjects in the non-HBO cont
rol group (range 5-33). Most of the published reports have several potentia
l sources of bias, including, but nor limited to, inadequate evaluation of
comorbid conditions relevant to wound healing, small sample size, and poor
documentation of wound size or severity. Four of the seven reports involvin
g the diabetic foot were published by a group of researchers at the Univers
ity of Milan between 1987 and 1996.
CONCLUSIONS - Additional randomized placebo-controlled clinical trials in l
arge diabetic populations would further lend credence to the presumption th
at HBO therapy improves clinical outcomes. Given the relatively high cost o
f this treatment modality, perhaps a more acute awareness of the medical li
terature would reduce the economic burden that HBO therapy imposes on care
providers that are financially at risk.