Completed PHASE4 INTERVENTIONAL 2-arm NCT00621608

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

A Prospective, Double-blind, Randomized, Controlled Clinical Trial Comparing Standard Wound Care With Adjunctive Hyperbaric Oxygen Therapy (HBOT) to Standard Wound Care Only for the Treatment of Chronic, Non-healing Ulcers of the Lower Limb in Patients With Diabetes Mellitus.

Sponsor: Judy Dan Research and Treatment Centre Ontario Wound Care Inc

Conditions Chronic Ulcers of the Lower Limb Diabetes Mellitus

Interventions Hyperbaric Oxygen Therapy Placebo Hyperbaric Oxygen Chamber

Updated 5 times since 2017 Last updated: May 7, 2013 Started: Apr 30, 2008 Primary completion: Mar 31, 2013 Completion: Apr 30, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00621608, this PHASE4 trial focuses on Chronic Ulcers of the Lower Limb and Diabetes Mellitus and remains completed. Sponsored by Judy Dan Research and Treatment Centre Ontario Wound Care Inc, it has been updated 5 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4
Jan 2017 — Jun 2018 [monthly]

Completed PHASE4

First recorded

Apr 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Judy Dan Research and Treatment Centre Ontario Wound Care Inc
St. Joseph's Healthcare Hamilton
University Health Network, Toronto

Data source: St. Joseph's Healthcare Hamilton

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Toronto, Canada