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 NNT2 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 NNT2 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: July 2021 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.