EUCTR2008-003731-20-SE
Active, not recruiting
Not Applicable
Postoperative Hyperbaric Oxygen treatments to reduce complications in Diabetic patients undergoing Vascular Surgery (HODIVA) - A double blind, randomized controlled study - HODIVA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative complications after vascular surgery in the leg. This includes wound infections, wound dehiscience and necrosis
- Sponsor
- Karolinska Universitetssjukhuset
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients are eligible for inclusion if the following criteria are fulfilled
- •1\.Informed consent obtained
- •2\.Scheduled for lower extremity open vascular surgery
- •3\.Diabetes treated with insulin or oral antidiabetic medicine
- •4\. 18 years or older
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Patients having any of the following at randomization will not be included in the study
- •1\.Contraindications to HBO therapy
- •2\.Pregnancy
- •3\.Patients already in HBO treatment
- •4\.Creatinine \> 250 mmol/L
- •5\.NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
- •6\.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.
- •7\.Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices.
- •8\.Mental condition making the subject unable to understand the concepts and risk of the study
Outcomes
Primary Outcomes
Not specified
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