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Search / Trial NCT03594344

Additional Hyperbaric Oxygen After Lower Extremity Amputation

Launched by OSLO UNIVERSITY HOSPITAL · Jul 19, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Diabetic Foot Diabetes Lower Extremity Amputation Hyperbaric Oxygen Therapy Hbot

ClinConnect Summary

This clinical trial is studying the effects of hyperbaric oxygen therapy on patients who have had a lower limb amputation due to complications related to diabetes, such as chronic wounds or infections. After their surgery, participants will be randomly assigned to either a group that receives this special oxygen treatment or a group that does not. The aim is to see if the therapy can help improve healing and recovery after amputation.

To be eligible for this study, participants should be between the ages of 65 and 87 and must have had an amputation due to serious health issues like infections or poor blood flow. They also need to be cleared for hyperbaric oxygen therapy by a qualified doctor and be able to attend follow-up appointments. It's important to note that those who are pregnant or have dementia will not be able to participate. If you or a loved one qualify and decide to join, you can expect regular check-ins as part of the study to monitor progress and overall health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • Not fulfilling inclusion criteria
  • Pregnancy
  • Dementia

About Oslo University Hospital

Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.

Locations

Oslo, , Norway

Oslo, , Norway

Patients applied

0 patients applied

Trial Officials

Jonas V Rydinge, MD

Principal Investigator

Ullevål University Hospital, orthopedic department

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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