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Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers

NCT00621608 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2013-05-09

No results posted yet for this study

Summary

The purpose of this study is to determine if HBOT plus standard wound care is more effective than standard wound care alone at preventing the need for major amputation (metatarsal and up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of lower limbs.

Conditions

Interventions

PROCEDURE

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy (HBOT) will be provided 5 days per week for 6 weeks for a total of 30 treatments on average. Subjects will be placed into the hyperbaric chamber for approximately 90 minutes of HBOT at 2.4 ATA (partial pressure of oxygen = 1,800 mmHg) when inside the chamber. Subjects will receive dressing changes as required per standard of care.

PROCEDURE

Placebo Hyperbaric Oxygen Chamber

Patients will receive HBOT placebo 5 days per week for 6 weeks for a total of 30 treatments. Each patient will be placed into the hyperbaric chamber and will receive 90 minutes of room air while inside the chamber and the initial flow of air into the chamber will produce a small increase in pressure (0.3 ATA partial pressure of oxygen = 210 mmHg) which will then be released over a period of 10 minutes. Subjects will receive dressings changes as required per standard of care.

Sponsors & Collaborators

  • Judy Dan Research and Treatment Centre Ontario Wound Care Inc

    collaborator UNKNOWN

  • University Health Network, Toronto

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Daria O'Reilly, PhD · Programs for Assessment of Technology in Health Research Institute

  • Ludwik Fedorko, MD · Judy Dan Wound Care Centre/University Health Network

  • Ron Linden, MD · Judy Dan Wound Care Centre/University Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00621608 on ClinicalTrials.gov