Evaluation of Topical Wound Oxygen (two2) Therapy

NCT00871312 | Terminated DMC

• 1 other identifier: AOTI-001
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Diabetic Ulcer

Keywords

diabetes; diabetic; wound; ulcer; lower extremity; foot; oxygen; hyperbaric; topical wound oxygen

Outcome Measures

Primary Outcomes (1)

• Wound closure

  12 Weeks

Secondary Outcomes (5)

• The time to wound closure

  Variable

• The degree of wound closure

  4, 8, and 12 weeks

• The percentage of tissue types

  4, 8 and 12 weeks

• The type and amount of wound drainage or exudates

  4, 8 and 12 weeks

• The level of wound pain

  4, 8 and 12 weeks

Study Arms (2)

Topical Wound Oxygen Therapy

ACTIVE COMPARATOR

Subjects will receive four 90 minute treatments of two2 therapy per week

Device: Topical wound oxygen therapy

Placebo Therapy

PLACEBO COMPARATOR

Subjects will receive four 90 minute treatments of Placebo two2 therapy per week

Device: Topical wound oxygen Placebo

Interventions

Topical wound oxygen therapy DEVICE

90 minutes 4 days per week Active Topical Oxygen Therapy

Topical Wound Oxygen Therapy

Topical wound oxygen Placebo DEVICE

90 mins per day 4 days per week Placebo Therapy

Placebo Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AOTI Ltd.: lead

Study Sites (3)

AOTI Clinic

Buffalo, New York, 14214, United States

Location

Community Dermatology & Wound Healing Clinic

Mississauga, Ontario, L4Y 1A6, Canada

Location

Wound Care Clinic

Saint Catherines, Ontario, L2R2P7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Wounds and Injuries; Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura E Edsberg, Ph.D.

  Daamen College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: May 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

US (1); CA (2)