The Role of Hyperbaric Oxygen Therapy in Ischaemic Diabetic Lower Extremity Ulcers: a Double-blind Randomised-control Tr

1. The Role of Hyperbaric Oxygen Therapy in Ischaemic Diabetic Lower Extremity Ulcers: a Double-blind Randomised-control Trial Journal Club Presentation 7th July, 2003 Mentor: Dr A Lennox

2. Origin Two diabetic inpatients treated with hyperbaric oxygen for chronic non-healing ulcers Recent study known Medline search: MESH headings � �hyperbaric oxygenation� and �diabetic foot� and �ulcer� Limited to RCT Most recent article = double-blind RCT

3. Background 5-7% diabetics with lower limb ulcers Significant role of peripheral vascular disease Relative wound/tissue hypoxia Associated high risk of amputation Hyperbaric Oxygen Therapy

4. Study Type Randomised-control trial Double-blinded

5. Objectives Primary Does hyperbaric oxygen have a beneficial effect on diabetic lower extremity ulcers in patients with peripheral vascular disease? Secondary Improvement in quality of life Limited economic comparison

6. Inclusion Criteria Diabetic patient at Hull Royal Infirmary Ulcer size >1cm and <10cm Failure of 6 weeks of �optimal medical management� Peripheral vascular disease confirmed by ABI HbA1c < 8.5% Not suitable for surgery

7. Methods Randomised into control vs. treatment Treatment: 100% HBO at 2.4 atmospheres for 90min/day, total of 30 sessions (6 weeks) Control: same chamber receiving hyperbaric air Decompression time 20 minutes Regular attendance at multidisciplinary clinic Treatment of infection

8. Endpoints Primary Ulcer surface area Complete epithelialisation Amputation (major or minor) Secondary Total costs over one year Depression, anxiety and general health scores

9. Assessment 15 treatments 30 treatments 6 weeks 6 months 12 months

10. Analysis Not fully disclosed P value <0.05 as significant

11. Recruitment 25 -7 18 9 9 -1 -1 8 8 (treatment) (control)

12. Results Complete wound healing = complete epithelialisation 6 weeks: Treatment � 5/8 Control � 1/8 1 year: Treatment � 5/8 Control � 0/8 100% median decrease in wound area in treatment group vs 52% in control (6 weeks)

13. Results (2) No difference in minor or major amputation rates Significant improvement in depression and anxiety scores No difference in physical functioning �2960 cost saving with hyperbaric treatment

14. Conclusions Hyperbaric oxygen enhances the healing of diabetic lower limb ulcers in patients with confirmed PVD Benefits of HBO continue following discontinuation of treatment (figure 1) Cost-effective form of adjunctive treatment for the appropriate patient Acknowledgement of potential side effects

15. Discussion Positives RCT double-blind Treatment was consistent with �best-practice� Results consistent with literature results Good long term follow-up

16. Discussion (2) Negatives Small sample size Randomisation issues Results lack explanation Selection of one ulcer in patients with multiple ulcers