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April 12, 2013
Oxygen Treatment May Not Help Foot Ulcers
This was somewhat of a shocker when I
received the email mail recently from a reader in Great Britain, and
then later finding it in a newsletter. I have been following several
news outlets about hyperbaric oxygen therapy for different types of
topics, but had not seen this coming. I will admit at first I did
not believe it and had to read it several times. I appreciate the
reader for having alerted me to this as I may have missed this study
Reuters Health reported this and I will
attempt to analyze the study for materials not in the press release.
The results of this study do call into question results of previous
studies, but this study seems to vary and be about foot ulcers only.
The prior studies were more centered on wounds and skin problems in
areas above the ankle. This is a distinction that may or may not be
valid, but still needs to be evaluated. Dr. Stephen Thom, a
professor at the Perelman School of Medicine in Philadelphia was very
realistic in his analysis and how this needs to be reviewed to see
what differences there are.
Please note that HBO (hyperbaric
oxygen) and HBOT (hyperbaric oxygen therapy) are usable
interchangeably, although HBO may not be as rigorous in its
application. This possible variable needs to be explored. The study
authors did state that further study is needed to understand the
current results and the effects of oxygen treatments. They are also
concerned that the people chosen from the National Healing
Corporation (NHC) may have had more severe problems although they
tried to compensate for that.
Covariates are a continuous control
variable that is observed rather than manipulated, but can affect the
outcome included age, sex, wound duration at enrollment, wound size
at enrollment, Wagner grade, number of wounds on the patient, wound
location, history of neuropathy, history of wound
recurrence, and history of osteomyelitisor abscess. Osteomyelitis is an
infectious, usually painful inflammatory disease of bone that is
often of bacterial origin and may result in death of bone tissue.
To minimize bias the researchers used a
PS approach. The propensity score (PS) is the conditional
probability of assignment to a particular treatment given a vector of
observed covariates. This allowed the researchers to achieve balance
on observed covariates between treatment groups so that the treatment
groups were more comparable. The PS provides a summary value for the
potential measured confounders.
The PS represents a summary value of
the potential covariates for each patient and is defined, regardless
of the actual treatment choice, as the probability that each patient
would receive the treatment of interest given the background
covariates of that subject. The PS model was used to balance a
number of baseline covariates such as age, sex, wound age, wound
size, Wagner wound grade = 2, the number of wounds on the patient,
history of neuropathy, history of wound recurrence, and history of
osteomyelitis or abscess. Importantly, wound age, wound size, and
Wagner wound grade = 2 at ﬁrst visit are highly predictive of the
likelihood that a subject will heal and has been used in other PS
studies of wound therapies.
Wagner Grading System for Diabetic Foot
Infections is the following:
- 0 - Intact Skin - 1 - Superficial
ulcer of skin or subcutaneous tissue - 2 - Ulcers extend into
tendon, bone, or capsule - 3 - Deep ulcer with osteomyelitis, or
abscess - 4 - Gangrene of toes or forefoot - 5 - Midfoot or
This study does point out how important
it is to have our feet examined on a regular basis to head off
problems before they get to this stage. I hope that this study is
not reflective of other problems we may encounter with hyperbaric
oxygen therapy in the future. I will be looking for more studies to
see if there are further problems, or if it is the foot ulcers that
are the problem.
For a past blog on hyperbaric oxygen therapy, read my blog here.