Additional Hyperbaric Oxygen After Lower Extremity Amputation

NCT ID: NCT03594344

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-04
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

Hyperbaric oxygen therapy has been used to treat hard to heal wounds for decades. Amputation, especially distal lower extremity amputations have the same problem with healing and patients often need to be re-amputated more proximally. In these patients oxygen levels are often the decisive factor. Providing additional oxygen under hyperbaric conditions will increase tissue oxygen concentration sufficient for the amputation stump to heal. This will give the patients a more distal amputation with better condition for ambulation.

Conditions

Diabetes Mellitus; Claudication, Intermittent; Critical Limb Ischemia; Osteomyelitis; Amputation; Lower Extremity Ulcer; Diabetic Angiopathy; Diabetic Neuropathies; Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type: PROCEDURE

Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions

Control group

Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric oxygen therapy

Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions

Intervention Type: PROCEDURE

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

• Pregnancy
• Dementia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diakonhjemmet Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Ellingsen Husebye

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonas V Rydinge, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevål University Hospital, orthopedic department

Locations

Diakonhjemmet Hospital

Oslo, , Norway

Site Status: RECRUITING

Orthopedic Center, Ullevål University Hopspital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jonas Rydinge, MD

Role: CONTACT

jonryd@ous-hf.no

+4792291795 ext. +47 92291795

Elisabeth I Ellingsen Husebye, MD, PhD

Role: CONTACT

uxngng@ous-hf.no

+47 95133773 ext. +47 95133773

Facility Contacts

Mads Sundet, MD

Role: primary

mads.sundet@icloud.com

+4741661770

Elisabeth Ellingsen Husebye, MD, PhD

Role: primary

+47 23027884

Jonas Rydinge

Role: backup

jonryd@ous-hf.no

+47 92291795 ext. +47 92291795

Other Identifiers

2017/1587

Identifier Type: -

Identifier Source: org_study_id