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Clinical Trials/ACTRN12611000505909
ACTRN12611000505909
Completed
未知

The effectiveness of hyperbaric oxygen therapy (HBOT) for healing chronic venous leg ulcers: A randomised, double blind, placebo-controlled trial

Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC0 sites84 target enrollmentMay 16, 2011
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ConditionsVenous leg ulcersCardiovascular - Diseases of the vasculature and circulation including the lymphatic system

Overview

Phase
未知
Intervention
Not specified
Conditions
Venous leg ulcers
Sponsor
Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC
Enrollment
84
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 16, 2011
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC

Eligibility Criteria

Inclusion Criteria

  • •Persons presenting with a venous leg ulcer that have an Ankle branchial pressure index between 0\.8 and 1\.2, a TCOM reading that indicates a hypoxic wound responsive to an oxygen challenge, who are not at risk for hyperbaric\-related complications and whose ulcer has not responded to standard treatment (i.e., \<50% reduction in ulcer area following 4 weeks of treatment.

Exclusion Criteria

  • •1\. Persons with cognitive impairment.
  • •2\. Persons with an Ankle Branchial Pressure Index \<0\.8 or \>1\.2\.
  • •3\. Persons with leg ulcers of non\-venous aetiology.
  • •4\. Persons considered to be at specific risk for hyperbaric\-related complications, as specified below:
  • •\-pregnancy
  • •\-concurrent administration of disulfuram, or antineoplastic agents doxorubicin and cisplatinum.
  • •\-reactive airway disease (COPD with CO2 retention), radiographic evidence of pulmonary blebs/bullae
  • •\-untreated pneumothorax or history of spontaneous pneumothorax
  • •\-previous documented ejection fraction less than 35% or cardiovascular instability
  • •\-history of seizures \- except childhood febrile seizures

Outcomes

Primary Outcomes

Not specified

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