Evaluation of Topical Wound Oxygen (two2) Therapy

January 8, 2014 updated by: AOTI Ltd.

A Randomized, Double-blinded, Parallel Group, Placebo-Controlled, Multi-Center Trial of Topical Wound Oxygen Therapy in the Treatment of Diabetic Lower Extremity Ulcers

The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The AOTI two2 therapy trial is a randomized, double-blinded, parallel group, placebo-controlled, multi-center study intended to evaluate the efficacy of Topical Wound Oxygen (two2) therapy in relation to placebo when added to standard of care in the treatment of diabetic lower extremity ulcers.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4Y 1A6
        • Community Dermatology & Wound Healing Clinic
      • St. Catherines, Ontario, Canada, L2R2P7
        • Wound Care Clinic
  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • AOTI Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject or legal representative has read, understands, and has signed the Institutional Review Board (IRB)-approved Informed COnsent Form (ICF) prior to enrollment in the study;
  • Subject is 18 years of age or older;
  • Subject has a current diagnosis of Type I or Type II diabetes mellitus;
  • Subject has a diabetic lower extremity ulcer;
  • Subject's index ulcer is at least 1.0cm2 in area;
  • Subject's index ulcer is a superficial, partial or full thickness skin ulcer (Wagner Classification System I, II or III) which has been present for at least 4 weeks at the time of initial screening that has not improved with standard of care;
  • Subject's index ulcer appears to be free of sinus tracts and tunneling;
  • Subject's index ulcer exhibits no signs of moderate or severe clinical infection;
  • In the event of multiple wounds on the same foot, the index ulcer will be the largest ulcer meeting the other inclusion criteria;
  • In the event of multiple wounds on the same foor, the index ulcer is at least 2 cm from any additional wound edge;
  • Women of childbearing potential must not be pregnant or lactating;
  • Subject and/or caregiver are willing and able to comply with all specified care and visit requirements, and subject has a reasonable expectation of completing the study;
  • Subject must be fit to undertake the study trial in the opinion of the referring doctor
  • Subject's Great Toe pressure is greater than 20mmHg.

Exclusion Criteria:

  • Subject is currently enrolled in another investigational device or drug trial, or has been previously enrolled in investigative research for a device or pharmaceutical agent within the last 30 days;
  • Subject's index ulcer has gangrene or gangrene is located on any part of the foot with the index ulcer;
  • Subject has an acute and/or active Deep Vein Thrombosis;
  • Subject is currently receiving or has received in the last six (6) months radiation or chemotherapy;
  • Subject has received growth factor therapy within seven (7) days prior to initial screening;
  • Subject has a significant medical condition that would impair wound healing, for example: severe liver disease, aplastic anemia, scleroderma, malnutrition, malignancy, etc;
  • Subject has known or suspected osteomyelitis;
  • Other than debridement, the underlying wound pathology requires surgical correction for the index ulcer to heal;
  • Subject is receiving or has received corticosteroids (all applications), immunosuppressive agents, or other drugs that would impair wound healing within seven (7) days prior to initial screening or is anticipated to require them during the course of the study;
  • Subject has an acute or active Charcot foot per clinical and radiology results or significant bony prominences that would preclude adequate off-loading with the standard off-loading device. The presence of Charcot foot in itself does not exclude the subject;
  • Subject has known HIV, hepatitis, active cancer (except basal cell and non-melanoma skin cancer), or a bleeding disorder;
  • Subject is undergoing renal dialysis;
  • Subject suffers from known alcohol or drug abuse;
  • Use of the standard off-loading device is contra-indicated or cannot be appropriately fitted to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Topical Wound Oxygen Therapy
Subjects will receive four 90 minute treatments of two2 therapy per week
Device: Topical wound oxygen therapy
90 minutes 4 days per week Active Topical Oxygen Therapy
PLACEBO_COMPARATOR: Placebo Therapy
Subjects will receive four 90 minute treatments of Placebo two2 therapy per week
Device: Topical wound oxygen Placebo
90 mins per day 4 days per week Placebo Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound closure
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to wound closure
Time Frame: Variable
Variable
The degree of wound closure
Time Frame: 4, 8, and 12 weeks
4, 8, and 12 weeks
The percentage of tissue types
Time Frame: 4, 8 and 12 weeks
4, 8 and 12 weeks
The type and amount of wound drainage or exudates
Time Frame: 4, 8 and 12 weeks
4, 8 and 12 weeks
The level of wound pain
Time Frame: 4, 8 and 12 weeks
4, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AOTI Ltd.

Investigators

  • Principal Investigator: Laura E Edsberg, Ph.D., Daamen College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (ESTIMATE)

March 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOTI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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