LONDON , 4-5 December 1998

The three conditions adversely affecting the outcome and length of treatment are:

• persistent soft tissue infection
• critical limb ischaemia
• osteomyelitis

The Jury was aware of the lack of studies in animal models and humans specifically addressing the above points in diabetes. However, there was evidence of the efficacy of HBO in animal and human studies in radiotherapy‑induced hypoxia. There was evidence from animal studies in non-diabetic models of the efficacy of HBO in osteomyelitis and soft tissue infections; however, evidence from diabetic models remained to be presented. (Level 1 evidence).

Patients with diabetic foot problems warrant treatment by foot care teams with careful evaluation of metabolic, neuropathic and vascular factors. Potential candidates for HBO may include those with Wagner grade 3 to 5 lesions treated unsuccessfully by standard methods when amputation seemed a possibility. There was some evidence from a number of trials, each of which suffered f rom methodological problems, to support the use of HBO in ischaemic limb‑threatening problems in diabetic patients. (Level 2 evidence). 

A result of the meeting was the recognition of the urgent need for a collaborative international trial for the application of HBO in diabetic foot lesions. Pre‑treatment evaluation should include an assessment of the probability of its success which might include:

• TcPO2 and O2 challenge at pressure.
• Assessment of peripheral circulation by invasive and non‑invasive methods.

There was evidence from a number of specialist diabetic foot centres that the multidisciplinary team approach reduced the incidence of recurrent ulcerations and amputations. (Level 3 evidence).

If HBO was to be used in the diabetic foot, it should always be in the multidisciplinary team setting.

A priori definitions of primary and secondary end‑points in clinical trials of HBO were essential. These may include limb salvage, length of hospitalization, rates of healing and cost efficacy. Assessment of quality of life and foot function should always be included in such studies. Careful monitoring of potential adverse effects, including diabetic retinopathy should occur.

Data suggested that the cost of HBO was equivalent to other new treatments in the diabetic foot, and may be cost effective. The proposed randomized controlled trial in diabetic foot lesions must include cost-effectiveness analysis.