FOURTH EUROPEAN CONSENSUS CONFERENCE ON HYPERBARIC MEDICINE
HYPERBARIC OXYGEN IN THE MANAGEMENT OF FOOT LESIONS IN DIABETIC PATIENTS
LONDON , 4-5 December 1998
|QUESTION 1- What is the rationale for HBO in the treatment of diabetic foot lesions?|
The three conditions adversely affecting the outcome and length of treatment are:
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).
|QUESTION 2- Which diabetic patients may benefit from HBO for the treatment of foot lesions?|
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:
|QUESTION 3- What is the place of HBO in the multidisciplinary approach to these lesions?|
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
|QUESTION 4- How can the efficacy of HBO for these lesions be evaluated?|
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.
|QUESTION 5- Is HBO cost-effective in the treatment of these lesions?|
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.