The
addition of hyperbaric oxygen to conventional treatment of diabetic foot ulcers
may improve amputation risk and healing rate over three years.
Clinical Bottom Line:
1.
Trend to improved healing and lower amputation rate with hyperbaric oxygen
that does not reach statistical significance.
Appraised
by: Mike Bennett, Dept of Diving and
Hyperbaric Medicine, Prince of Wales Hospital
Sydney; Friday, 28 February 2003
Clinical
Scenario: A diabetic with
limb-threatening foot lesions.
Three-part
Question: For diabetic patients with
limb-threatening foot lesions, does the addition of hyperbaric oxygen to a
comprehensive wound care regime, result in any reduction in the rate of major
amputation or increased chance of wound healing?
Search
Terms: Diabetic angiopathies, diabetic
foot
The
Study:
Non-blinded randomised
allocation first 28 patients, next 10 allocated by availability of HBO,
intention-to-treat unclear.
Patients with chronic
limb-threatening diabetic foot lesions (>2 months) that had failed to heal with standard
therapy.
Control group (N = 21; 21
analysed): 'Conventional' treatment with multidisciplinary team.
Experimental group (N = 17; 17
analysed): All conventional measures plus 40 (4 subjects) or 60 sessions of 100%
oxygen at 2.5 ATA for 90 minutes daily 5/7.
The
Evidence:
|
Outcome |
Time to
Outcome |
Control
Group |
HBO Group |
Relative
risk reduction |
Absolute
risk reduction |
NNT |
|
Healed |
3 years |
.48 |
.76 |
58% |
0.28 |
4 |
|
95% CI: |
|
|
|
-3% to 100% |
-0.02 to 0.58 |
NNT=2 to INF
NNH=268 to INF |
|
Amputation |
3 years |
.33 |
.12 |
64% |
0.210 |
5 |
|
95% CI: |
|
|
|
-13% to 100% |
-0.04 to 0.46 |
NNT=2 to INF
NNH=23 to INF |
Comments:
1.
Randomisation partial only and method not described.
2. Small trial (38 patients
only) with low power to detect a significant difference.
3. The clinical improvement
suggested is highly significant.
4. Conventional regimen sounds
comprehensive and all patients were not suitable for vascular reconstruction.
Expiry date: September 2004
References:
1. Kalani M, Naderi N, Lind F.
Hyperbaric oxygen therapy for wound healing and limb salvage in diabetic foot
lesions: three year follow-up. Undersea and Hyperbaric Medicine 2000;
27(suppl):44-45.
2. Kalani M, Jorneskog G, Naderi N, Lind F, Brismar K. Hyperbaric oxygen (HBO) therapy in treatment of diabetic foot ulcers. Long term follow-up. Journal of Diabetes and its Complications 2002; 16:153-158.
