NCT03594344

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
8mo left

Started Jul 2018

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jul 2018Dec 2026

First Submitted

Initial submission to the registry

June 15, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

July 4, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 30, 2025

Status Verified

September 1, 2024

Enrollment Period

7.5 years

First QC Date

June 15, 2018

Last Update Submit

March 25, 2025

Conditions

Diabetes MellitusClaudication, IntermittentCritical Limb IschemiaOsteomyelitisAmputationLower Extremity UlcerDiabetic AngiopathyDiabetic NeuropathiesDiabetic Foot

Keywords

Diabetic footDiabetesLower extremity amputationHyperbaric oxygen therapyHBOT

Outcome Measures

Primary Outcomes (1)

  • Intact skin with no abnormal openings at the site of primary amputation

    Healed and intact skin at the site of primary amputation without need for more proximal amputation.Healed amputation is defined as epithelialization of the wound examined by a orthopedic surgeon. Level of primary amputation is decided by the surgeon. Planned 2-session amputation, for example Guillotine amputation with a final amputation later is considered being primary amputation. Healed primary amputation will be measured at 12 weeks.

    12 weeks

Secondary Outcomes (23)

  • Intact skin with no abnormal openings at the site of amputation at 6 months

    6 months

  • Intact skin with no abnormal openings at the site of amputation at 9 months

    9 months

  • Intact skin with no abnormal openings at the site of amputation at 1 year

    12 months

  • Time to closed and intact skin at the site of amputation

    1 year

  • Reamputations

    1 year

  • +18 more secondary outcomes

Study Arms (2)

Hyperbaric oxygen therapy

EXPERIMENTAL

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.

Procedure: Hyperbaric oxygen therapy

Control group

NO INTERVENTION

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

Interventions

Hyperbaric oxygen therapyPROCEDURE

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

Hyperbaric oxygen therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diakonhjemmet Hospital

Oslo, 0319, Norway

RECRUITING

Orthopedic Center, Ullevål University Hopspital

Oslo, 0407, Norway

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusIntermittent ClaudicationChronic Limb-Threatening IschemiaOsteomyelitisLeg UlcerDiabetic AngiopathiesDiabetic NeuropathiesDiabetic Foot

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesChronic DiseaseDisease AttributesPathologic ProcessesIschemiaBone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesFoot Ulcer

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Jonas V Rydinge, MD

    Ullevål University Hospital, orthopedic department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Rydinge, MD

CONTACT

+4792291795jonryd@ous-hf.no

Elisabeth I Ellingsen Husebye, MD, PhD

CONTACT

+47 95133773uxngng@ous-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2018

First Posted

July 20, 2018

Study Start

July 4, 2018

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

March 30, 2025

Record last verified: 2024-09

Locations

NO(2)