Evaluation of Topical Wound Oxygen (two2) Therapy

This study has been terminated.
(Low recruitment rate meaning unable to complete the study in a timely manner)
Sponsor:
Information provided by (Responsible Party):
AOTI Ltd.
ClinicalTrials.gov Identifier:
NCT00871312
First received: March 26, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Diabetic Ulcer
Device: Topical wound oxygen therapy
Device: Topical wound oxygen Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Parallel Group, Placebo-Controlled, Multi-Center Trial of Topical Wound Oxygen Therapy in the Treatment of Diabetic Lower Extremity Ulcers

Resource links provided by NLM:


Further study details as provided by AOTI Ltd.:

Primary Outcome Measures:
  • Wound closure [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to wound closure [ Time Frame: Variable ] [ Designated as safety issue: No ]
  • The degree of wound closure [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
  • The percentage of tissue types [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • The type and amount of wound drainage or exudates [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • The level of wound pain [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: May 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871312

Locations
United States, New York
AOTI Clinic
Buffalo, New York, United States, 14214
Canada, Ontario
Community Dermatology & Wound Healing Clinic
Mississauga, Ontario, Canada, L4Y 1A6
Wound Care Clinic
St. Catherines, Ontario, Canada, L2R2P7
Sponsors and Collaborators
AOTI Ltd.
Investigators
Principal Investigator: Laura E Edsberg, Ph.D. Daamen College
  More Information

No publications provided

Responsible Party: AOTI Ltd.
ClinicalTrials.gov Identifier: NCT00871312     History of Changes
Other Study ID Numbers: AOTI-001
Study First Received: March 26, 2009
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AOTI Ltd.:
diabetes
diabetic
wound
ulcer
lower extremity
foot
oxygen
hyperbaric
topical wound oxygen

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014