Status:
WITHDRAWN
Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery
Lead Sponsor:
Karolinska Institutet
Conditions:
Diabetes
Peripheral Arterial Disease
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01002209
Start Date
October 1 2019
End Date
October 1 2020
Last Update
December 2 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karolinska University Hospital
Stockholm, Sweden, 17176