Does Applying More Oxygen Cure Lower Extremity Sores?

Rationale:

Chronic leg ulcers in diabetic patients pose a major health problem. Conventional treatment is complex and costly. Current evidence on the (cost-)effectiveness of hyperbaric oxygen therapy (HBOT) as an adjunct to standard wound care is equivocal because studies have been heterogenous and have included small numbers of patients. As a consequence, cost-effectiveness is still unclear.



Objectives:

The primary objective is to assess whether the effectiveness of HBOT as an adjunct to standard wound care in preventing amputations and improving wound healing in ischemic diabetic ulcers justifies its costs.

Secondary objectives are to assess the quality of life and the need for vascular interventions following both treatments.



Study design:

Multicenter randomized controlled trial.



Study population:

275 diabetic patients with ischemic leg ulcers.



Intervention:

Patients will be randomly assigned to HBOT plus usual wound care or usual wound care only. HBOT will comprise 40 sessions, 90 minutes each, over an eight week period.



Main endpoints:

Primary endpoints are freedom of major (above ankle) amputations after 12 months, and occurrence of and time to complete wound healing.
Secondary endpoints are pain scores, freedom of minor amputations after.

The hypothesis is that HBOT will have additional beneficial effect in terms of wound healing and/or limb salvage over conventional (surgical or non-surgical) care for diabetic patients with leg ischaemia, with acceptable costs.

Patients in both groups will be monitored for 12 months after inclusion. Throughout the 8 week treatment phase, all patients collect data about pain scores and wound healing. The questionnaires (costs, ALDS, SF-36, VASQUOL and EQ-5D) will be send to the patients home adress, accompanied by a prepaid return envelope.
Subsequently follow-up is performed by the vascular surgeon after 8 weeks, 3 months, 6 months, 12 months and after any vascular intervention. During this visits at the outpatient clinic the surgeon will collect outcome measures as mentioned.

Patients are placed in an airtight cabin and receive 100% 2.5 ATA. A complete course of HBOT treatments involves 40 sessions, once daily, for 90 minutes.
The control group will receive wound care as usual.