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 Two abstracts were clearly superseded by the full report.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 2013
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.
4.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(1):48.


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