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

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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

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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

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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

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Study Type

• Randomised-control trial
• Double-blinded

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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

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Inclusion Criteria

• Diabetic patient at Hull Royal Infirmary
• Ulcer size gt1cm and lt10cm
• Failure of 6 weeks of optimal medical
  management
• Peripheral vascular disease confirmed by ABI
• HbA1c lt 8.5
• Not suitable for surgery

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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

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Endpoints

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

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Assessment

• 15 treatments
• 30 treatments
• 6 weeks
• 6 months
• 12 months

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Analysis

• Not fully disclosed
• P value lt0.05 as significant

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Recruitment

• 25
• -7
• 18
• 9 9
• -1 -1
• 8 8
• (treatment) (control)

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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)

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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

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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

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Discussion

• Positives
• RCT double-blind
• Treatment was consistent with best-practice
• Results consistent with literature results
• Good long term follow-up

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Discussion (2)

• Negatives
• Small sample size
• Randomisation issues
• Results lack explanation
• Selection of one ulcer in patients with multiple
  ulcers