Faglia
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 Control Hyperbaric improvement on dorsum of foot at completion of treatment: 5.0 +/- 5.4 mmHg 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: July 2021
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.
