Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery (HODiVA)

Karolinska Institute

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Diabetes

Arterial Occlusive Disease

Peripheral Arterial Disease

Treatments

Procedure: Sham HBO

Procedure: Hyperbaric Oxygen treatment (HBO)

Study type

Interventional

Funder types

Other

Identifiers

NCT01002209

HODIVA

Details and patient eligibility

About

This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes.

Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients are eligible for inclusion if the following criteria are fulfilled
Informed consent obtained
Scheduled for lower extremity open vascular surgery
Diabetes treated with insulin or oral antidiabetic medicine
Age ≥ 18 years

Exclusion criteria

Contraindications to HBO therapy
Pregnancy (women of childbearing potential will undergo pregnancy test before inclusion)
Patients already in HBO treatment
Vascular reoperation
Creatinine > 250 mmol/L
NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
Clinically significant chronic obstructive pulmonary disease.
Acute sepsis.
Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up.
Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices.
Mental condition making the subject unable to understand the concepts and risk of the study