The
addition of hyperbaric oxygenation to a comprehensive diabetic foot ulcer
protocol resulted in a lower major amputation rate.
Clinical
Bottom Line:
1.
The addition of hyperbaric oxygenation to the regime resulted in significantly
fewer major amputations.
2.
The transcutaneous oxygen tensions in the affected feet were significantly
improved.
Appraised
by:
Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital,
Sydney; Friday, 13 November, 1998
Clinical
Scenario:
A diabetic with a foot ulcer threatening to require amputation.
Three-part
Question:
In diabetic patients with lower limb wounds, does the adjunctive use of
hyperbaric oxygenation in addition to other intensive treatment therapies,
result in a lower rate of morbidity and or mortality?
Search
Terms:
Hyperbaric oxygenation, diabetes.
The
Study:
Non-blinded
randomised controlled trial without intention-to-treat.
Adult
diabetic patients with problematic foot ulcers referred to a major diabetic foot
clinic.
Control
group (N = 33; 32 analysed): A comprehensive diagnostic-therapeutic protocol by
a multi-disciplinary team including diabetic control, wound care, podiatry and
vascular surgery.
Experimental
group (N = 35; 34 analysed): As above with the addition of hyperbaric
oxygenation at 2.2 to 2.5 ATA for 90 minutes daily until healing established or
treatment abandoned in favour of amputation.
The
Evidence:
|
Outcome |
Time
to Outcome |
Protocol |
Protocol
plus HBO |
Relative
risk reduction |
Absolute
risk reduction |
Number
needed to treat |
|
Major
Amputation |
Variable |
0.344 |
0.088 |
74% |
0.26 |
4 |
|
95%CI
|
|
|
|
19%
to 100% |
0.07
to 0.45 |
2
to 15 |
Transcutaneous
oxygen tension
improvement on dorsum of foot at completion of treatment: Control: 5.0 +/- 5.4
mmHg, Hyperbaric:14.0 +/- 11.8 mmHg. P=0.0002
Comments:
1.
Unblinded study.
2.
The time to estimation of the outcome was not specified and may influence the
long-term differences in major amputation rate.
3.
The significance of the higher transcutaneous oxygen tensions in the hyperbaric
arm of the study is not clear.
4.
The average number of hyperbaric treatment sessions was 38 +/-8.
Expiry
date:
References:
1.
Faglia E, Favales F, Aldeghi A, Calia P, Quarantiello A, Oriani G,
Michael M, Campagnoli P, Morabito A. Adjunctive systemic hyperbaric oxygen
therapy in the treatment of diabetic foot ulcer. A randomized study. Diabetes
Care 1996;19:1338-43.
2.
Faglia
E, Favales F, Aldeghi A, Calia P, Quarantiello A, Oriani G, Michael M,
Campagnoli P, Morabito A. Adjunctive systemic hyperbaric oxygen therapy in the
treatment of diabetic foot ulcer. A randomized study. Proceedings of the
International Joint Meeting on Hyperbaric and Underwater Medicine, Marroni A,
Oriani G, Wattel F eds. Grafica Victoria, Bologna 1996; 391-399.
