Improved
healing of ulcers, but no significant decrease in amputation rate in diabetic
patients with lower limb chronic wounds.
Clinical Bottom Line:
1. More ulcers healed at six weeks and one
year with the addition of hyperbaric oxygen therapy.
2. No difference in major amputation rate.
Three-part
Clinical Question: For diabetic patients with ischaemic lower-extremity ulcers, does the
addition of hyperbaric oxygen, compared to other measures alone, result in
improved healing or reduced amputation rates?
Search
Terms:
Diabetic ulcers, amputation
Appraised
by: Michael
Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital,
Sydney, 7th July 2003
Email: m.bennett@unsw.edu.au
The
Study: Double-blinded
randomised controlled trial with intention-to-treat.
The
Study Patients: Diabetic patients with non-healing lower limb ulcers for at least 6
weeks of medical management and no vascular reconstruction planned.
Control
group (N = 9; 8 analysed): Sham hyperbaric treatment with air breathing at
2.4ATA for ninety minutes daily to a total of 30 treatments. Intensive
multidisciplinary wound management.
Experimental
group (N = 9; 8 analysed): Regimen as above with 100% oxygen at 2.4ATA. Same
wound management.
The
Evidence:
|
Outcome |
Time
to outcome |
Sham
rate |
HBO
rate |
Relative
risk reduction |
Absolute
risk reduction |
NNT |
|
Failure
to heal |
6
weeks |
0.78 |
0.33 |
57% |
0.45 |
2 |
|
95%
CI: |
|
|
|
4%
- 100% |
0.03
to 0.86 |
1
to 29 |
|
Failure
to heal |
1
year |
0.89 |
0.33 |
63% |
0.56 |
2 |
|
95%
CI: |
|
|
|
21%
- 100% |
0.19
to 0.93 |
1
to 5 |
|
Non-Event
Outcomes |
Time
to outcome |
Control
group |
Experimental
group |
Difference |
|
Median
wound area reduction (%) Number
of visits (sd) Average
cost (UKP) |
1
year 1
year 1
year |
52 136.5
(126) 7,946 |
100 33.8
(62) 4,
972 |
P=0.027 95%CI
–3 to 209 2,960 |
Comments:
1.
Small study with low power to detect a significant reduction in major amputation
rate. One major amputation in each group.
2.
No significant overall difference in SF36 between groups.
3.
Two abstracts were clearly superseded by the full report.
4.
Results in abstracts were by ulcer, final paper involved selection of 1 ulcer at
random per patient.
Kill or Update
By: July
2004
Citation/s:1.
Abidia A, Kuhan G, Laden G, Bahia H, Johnson B, Wilkinson A, Renwick P, Masson
E, McCollum P. Role of hyperbaric oxygen therapy in ischaemic, diabetic,
lower-extremity ulcers: a double-blind randomized controlled study. British
Journal of Surgery [Surgical Research Society Abstracts] 2001; 88(5):744.
2. Abidia A, Kuhan
G, Laden G, Bahia H, Johnson B, Wilkinson A, Renwick P, Masson E, McCollum P.
Hyperbaric oxygen therapy for diabetic leg ulcers- a double-blind
randomised-controlled trial. Undersea and Hyperbaric Medicine 2001;
28(Suppl):64.
3. Abidia A, Laden
G, Kuhan G, Johnson BF, Wilkinson AR, Renwick PM, Masson EA, McCollum PT. The
role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers:
a double-blind randomised-controlled trial. European Journal of Vascular Surgery
2003; 25:513-518.
