The effectiveness of hyperbaric oxygen therapy (HBOT) for healing venous leg ulcers

Not Applicable

Completed

• Conditions: Venous leg ulcers; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12611000505909
• Lead Sponsor: Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

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
-unable to follow simple commands, not orientated to person, place, time.
-prior chest surgery, middle ear surgery, optic neuritis, fever, congenital , spherocytosis, claustrophobia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to ulcer healing[Assessed every week up to 12 weeks from randomisation.];Number of healed ulcers/group. Ulcer area will be calculated using wound tracings, digital photography and digital planimetry to determine area reduction, percent reduction and total healing rates. A healed ulcer is defined as full epithelialisation maintained for at least two weeks.[Assessed every week up to 12 weeks from randomisation.];ulcer area percentage reduction in each group[Assessed every week up to 12 weeks from randomisation.]