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Clinical Trials/2024-511743-26-00
2024-511743-26-00
Completed
Phase 4

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

Amsterdam UMC Stichting6 sites in 2 countries194 target enrollmentStarted: November 18, 2024Last updated:
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Overview

Phase
Phase 4
Status
Completed
Enrollment
194
Locations
6
Primary Endpoint
Major amputation rate after 12-months of follow-up
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The aim of the study is to confirm or refute the hypothesis that HBOT is effective as an adjunctive treatment to standard wound care for patients with an ischemic DFU to prevent major amputations and to establish the optimal number of sessions to obtain this purported effect.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Type I or II diabetes
  • •One or more deep and clinically infected lower extremity ulcers, classified as Meggit-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W>1, I>1 and fI>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
  • •Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg
  • •Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
  • •Patients have to be discussed in, and included after a multidisciplinary consultation.
  • •Written informed consent

Exclusion Criteria

  • •Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
  • •Insufficient proficiency of local language/English, or inability to complete the questionnaires
  • •Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
  • •End-stage renal disease requiring dialysis
  • •Metastasized malignancy
  • •Left ventricular failure with ejection fraction (EF) <20% or external pacemaker
  • •Recent thoracic surgery or middle ear surgery
  • •Severe epilepsy
  • •Uncontrollable high fever

Outcomes

Primary Outcomes

Major amputation rate after 12-months of follow-up

Major amputation rate after 12-months of follow-up

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Principal Investigator

Scientific

Amsterdam UMC Stichting

Study Sites (6)

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