Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis.
• Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist/Hyperbaric Medicine Physician.
• Able to cooperate and follow up appointments
• Included within 7 days after final surgery
Locations
Other Locations
Norway
Diakonhjemmet Hospital
RECRUITING
Oslo
Orthopedic Center, Ullevål University Hopspital
RECRUITING
Oslo
Contact Information
Primary
Jonas Rydinge, MD
jonryd@ous-hf.no
+4792291795
Backup
Elisabeth I Ellingsen Husebye, MD, PhD
uxngng@ous-hf.no
+47 95133773
Time Frame
Start Date: 2018-07-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Hyperbaric oxygen therapy
30 sessions of Hyperbaric oxygen therapy, 90min treatment at 2,4 ATA(atmosphere absolute) with 100% oxygen.First session must be given within 7 days after initial amputation. Treatment is given as outpatient treatment after discharge from hospital.
No_intervention: Control group
Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital.
Authors
Jonas Thomassen, Elisabeth Ellingsen Husebye
Related Therapeutic Areas
Sponsors
Collaborators: Diakonhjemmet Hospital
Leads: Oslo University Hospital