Ischemic diabetic foot ulcer wound on the foot with vascular insufficiency
Conditions
Interventions
Patients receive 20, 30 or 40 sessions of HBOT. The sessions last between the
90 and 120 minutes at 2.2-2.5 ATA.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Type I or II diabetes 2. Meggitt-Wagner 3 or 4 lower extremity ulcer(s), present for at least 4 weeks or after a minor amputation because of a previously existing ischemic DFU. In case more than one ulcer is present, the largest will be observed as target ulcer 3. Leg ischemia, characterized by a highest ankle systolic blood pressure
Exclusion criteria
Exclusion criteria: 1. Chronic Obstructive Pulmonary Disease (COPD) GOLD IV 2. Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing 3. End-stage renal disease requiring dialysis 4. Metastasized malignancy 5. Left ventricular failure with ejection fraction (EF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major amputation rate (above ankle) and (major)l after 3 years of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| - Amputation-free survival - Health-related quality of life - Complete wound healing - Pain scores - Need for additional (vascular) interventions - Cost-effectiveness and budget impact - Mortality - Patients perception of improvement - TcpO2 before, during and after HBOT | — |
Countries
Netherlands
Outcome results
None listed