FOURTH EUROPEAN CONSENSUS CONFERENCE ON
HYPERBARIC MEDICINEHYPERBARIC OXYGEN IN THE MANAGEMENT OF FOOTLESIONS IN DIABETIC PATIENTS

A two day meeting among European diabetes and hyperbaric health professionals
Friday/Saturday, 4/5 December 1998
Forte Posthouse Hotel, Bloomsbury, London, United Kingdom
A meeting with the support of the British Hyperbaric Association
Recognized for Continuing Medical Education
A review of fundamental questions in the use of hyperbaric oxygen therapy
in the management of foot lesions in diabetic patients
leading to a consensus for international publication

Conference Aims
The conference will discuss five fundamental questions in the use of hyperbaric oxygentherapy in the management of foot lesions in diabetic patients:
1. What is the rationale for hyperbaric oxygen in the treatment of foot lesions in thediabetic patient?
2. Which diabetic patients may benefit from hyperbaric oxygen for the treatment offoot lesions?
3. What is the place of hyperbaric oxygen in the multidisciplinary team approach tothese lesions?
4. How can the efficacy of hyperbaric oxygen for these lesions be evaluated?
5. Is hyperbaric oxygen cost effective in the treatment of these lesions?
The Conference will reach a consensus on these questions and produce a report forinternational publication.
Speakers
Dirk Bakker (Netherlands)
Bruno Martini (France)
Jörg Schmutz (Switzerland)
Jan Apelqvist (Sweden)
N.C. Shaper (Netherlands)
Mike Edmonds (United Kingdom)
Alethea Foster (United Kingdom)
T.K. Hunt (United States of America)
Jordi Desola (Spain)
Remi Neviere (France)
Alessandro Marroni (Italy)
R. Rychlik (Germany)
Pierre Fontaine (France).

Scientific Committee
Daniel Mathieu (France)
Giorgio Oriani (Italy)
Martin R. Hamilton-Farrell (United Kingdom)
Literature Reviewers
Bruno Martini (France)
Jörg Schmutz (Switzerland)
Jury Members
Chairman: Professor AJM Boulton, MD, FRCP. University of Manchester (United Kingdom).
Gérard Cathelinau (France)
Ernst Chantelau (Germany)
Ideho Takayashi (Japan)
Alberto de Leiva (Spain)
Francesco Malerba (Italy)
John Ross (United Kingdom)
Stephen Thom (United States of America)
Organizing Committee
Martin R. Hamilton-Farrell
Stephen BrearleyDavid Levy
Catherine Condon
The Questions
1.- What is the rationale for hyperbaric oxygen in the treatment of foot lesions in diabeticpatients?
2.- Which diabetic patients may benefit from hyperbaric oxygen for the treatment of footlesions?
3.- What is the place of hyperbaric oxygen in the multidisciplinary team approach tothese lesions?
4.- How can the efficacy of hyperbaric oxygen for these lesions be evaluated?
5.- Is hyperbaric oxygen cost effective in the treatment of these lesions?
PROGRAMME
Friday, December 4, 1998
Welcome - Professor Francis Wattel, President, European Committee for HyperbaricMedicine.
Welcome - Dr. Andrew Colvin, Chairman, British Hyperbaric Association.
Formal Opening of the Conference - Professor Sir Dillwyn Williams MA MD FRCPath FRCP,President, British Medical Association.
Opening Remarks - Professor Allen Hutchinson FRCGP FFPHM, University of Sheffield
School of Health and Related Research, Adviser on Diabetes to the UK Departments ofHealth.
Session 1(Chairmen: Professor Francis Wattel and Professor Allen Hutchinson)

•••Incidence and cost of foot lesions in diabetic patients - Jan Appelqvist (Sweden).
Pathophysiology and evaluation of foot lesions in diabetic patients - Nikolaas
Schaper (Netherlands)
Treatment of foot lesions in diabetic patients: medical aspects - Mike Edmonds(United Kingdom)

Session 2(Chairmen: Dr. M.R.Hamilton-Farrell and Dr. Andrew Colvin)•••

Treatment of foot lesions in diabetic patients: wound management - Alethea
Foster (United Kingdom).
Treatment of foot lesions in diabetic patients: surgical aspects - Carlo Caravaggi(Italy).
Hyperbaric oxygen and infection in diabetic foot lesions - Jordi Desola (Spain).

Session 3(Chairmen: Dr. Folke Lind and Dr. David Levy)•••

Oxygen and wound healing - Thomas Hunt (United States of America).
Clinical trials evaluating hyperbaric oxygen in the treatment of foot lesions indiabetic patients - Dirk Bakker (Netherlands).
Patient selection for hyperbaric oxygen treatment, and treatment evaluation Rémi Nevičre (France).

Session 4(Chairmen: Dr. Daniel Mathieu and Mr. Stephen Brearley)•••

Cost effectiveness of hyperbaric oxygen in the treatment of foot lesions in diabetic
patients - Alessandro Marroni (Italy) & R.Rychlik (Germany).
Experience of a multidisciplinary unit - Pierre Fontaine (France).
General discussion.

Saturday, December 5, 1998
Workshops
Examination of the diabetic foot.
The Diabetic Foot Clinic Team, King's College Hospital, London.
Sponsored by RDG Medical, United Kingdom.
Foot pressure and gait evaluation.
Presented and sponsored by Musgrave Systems Ltd., United Kingdom.
Footware for diabetic patients.
The G.C. Hanson Diabetic Centre, Whipps Cross Hospital, London.
Sponsored by Jane Saunders & Manning, United Kingdom.
Hyperbaric Oxygen Treatment.
The Hyperbaric Unit. Whipps Cross Hospital, London. Sponsored by Sechrist Industries
Inc., United States of America & Radiometer Ltd., United Kingdom.
Bioengineered Human Dermal Replacement.
The Diabetic Foot Clinic Team, King's College Hospital, London.
Sponsored by Smith & Nephew Healthcare Ltd., United Kingdom.
The Conference is supported by:Undersea and Hyperbaric Medical Society
European Underwater and Baromedical SocietyInternational Congress in Hyperbaric Medicine
Société de Physiologie et de Médecine Subaquatiques et Hyperbares de Langue Française(France)
Société Nationale Francaise de Médecine Interne (France)
Association de Langue Française pour l'Etude du Diabéte et des Maladies Métaboliques"ALFEDIAM" (France)
Société Suisse de Médecine Sub-Aquatique et Hyperbare (Switzerland)Societa Italiana di Medicina Subacquea e Iperbarica (Italy)
Societa di Anestesia Analgesia Rianimazione e Terapia Intensiva (Italy)
British Medical Association (United Kingdom)
University of Manchester Department of Medicine (United Kingdom)
University of Sheffield School of Health and Related Research (United Kingdom)
Kings Healthcare NHS Trust (United Kingdom)
National Hyperbaric Centre, Aberdeen (United Kingdom)Japanase Society for Hyperbaric Medicine (Japan)
Geselschafft für Tauch und Uberdruckmedizin (Germany)
Foundation Platform Hyperbare Zuurstof (Netherlands)
Academic Medical Center, Amsterdam (Netherlands)
Comité Coordinador de Centros de Medicina Hiperbárica - CCCMH (Spain)
The Conference has been assisted financially by:
British Hyperbaric Association (United Kingdom)
Forest Healthcare NHS Trust (United Kingdom)North West Emergency Recompression Unit (United Kingdom)
Diving Diseases Research Centre (United Kingdom)
Verband Deutscher Druckkammerzentren e.V. (Germany)

RECOMMENDATIONS OF THE JURY*QUESTION 1- What is the rationale for HBO in the treatment ofdiabetic foot lesions?
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 specificallyaddressing 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 andsoft 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 anumber of trials, each of which suffered f rom methodological problems, to support theuse of HBO in ischaemic limb-threatening problems in diabetic patients. (Level 2evidence).
A result of the meeting was the recognition of the urgent need for a collaborativeinternational 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.

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 themultidisciplinary team approach reduced the incidence of recurrent ulcerations andamputations. (Level 3 evidence).
If HBO was to be used in the diabetic foot, it should always be in the multidisciplinary
team setting.

QUESTION 4- How can the efficacy of HBO for these lesions beevaluated?
A priori definitions of primary and secondary end-points in clinical trials of HBO wereessential. These may include limb salvage, length of hospitalization, rates of healing andcost efficacy. Assessment of quality of life and foot function should always be included insuch studies. Careful monitoring of potential adverse effects, including diabetic
retinopathy should occur.

QUESTION 5- Is HBO cost-effective in the treatment of theselesions?
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 indiabetic foot lesions must include cost-effectiveness analysis.