Diabetic Foot Ulcers
Conditions
Keywords
HBOT, Diabetic foot ulcer, Hyperbaric Oxygen Therapy, DFU, Peripheral arterial disease
Brief summary
Overview of available data to assess the benefits of HBOT to DFU patients
Detailed description
10 year retrospective registry to measure outcomes regarding major amputations, mortality, hospital admissions in patients with a diabetic foot ulcer with peripheral ischaemia. Two groups will be compared: complementary HBOT and a control group.
Interventions
OTHERHBOT
Hyperbaric Oxygen Therapy
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus * Meggitt-Wagner classification grade 2-4, existing \> 4 weeks * Complete 1 year follow-up
Exclusion criteria
* Chronic Obstructive Pulmonary Disease (COPD) GOLD IV * Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within the last 3 months * Metastasized malignancy * Left ventricular ejection fraction (EF) \<20% or external pacemaker * Recent thoracic or middle ear surgery * Severe epilepsy * Uncontrollable high fever * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major amputation rate | 1 year | Major (above the ankle) amputation rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | Mortality |
| Amputation-free survival rate | 1 year | Amputation-free survival rate: percentage of patients who are alive with their leg. |
| Complete wound healing | 1 year | Complete wound healing |
| Pain score | 1 year | Pain score (10-point Visual Analogue Scale; 0= no pain, 10 is intolerable pain) |
| Additional vascular interventions | 1 year | Additional vascular interventions |
Countries
Netherlands
Contacts
Primary ContactJoost R Meijering, MD
Backup ContactDirk T Ubbink, MD, PhD
Outcome results
None listed