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A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Electrochemical Oxygen Concepts, Inc..
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Electrochemical Oxygen Concepts, Inc.
ClinicalTrials.gov Identifier:
NCT01645891
First received: July 18, 2012
Last updated: August 9, 2013
Last verified: August 2013
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary objective of this study is to evaluate the effectiveness of CDO in combination with standard moist wound therapy (MWT) on wound healing as compared to standard MWT alone.

Condition Intervention
Diabetic Foot Ulcer
Device: CDO electrochemical tissue oxygenation system
Device: Moist Wound Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TCO2-2012-01 A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Electrochemical Oxygen Concepts, Inc.:

Primary Outcome Measures:
  • Complete (100%) wound closure defined as complete re-epithelialization without drainage [ Time Frame: 12 weeks or wound closure ] [ Designated as safety issue: No ]
    Complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12


Secondary Outcome Measures:
  • Time to 50%, 75% and 100% wound closure [ Time Frame: 12 weeks or wound closure ] [ Designated as safety issue: No ]
    Time to 50%, 75% and 100% wound closure by using digital photography & computerized planimetric analysis

  • Pain Reduction [ Time Frame: 12 weeks or closure ] [ Designated as safety issue: No ]
    Pain Reduction from day 0 to week 12 or closure using the Wong-Baker Faces™ Pain Rating Scale

  • Quality of Life [ Time Frame: week 12 or wound closure ] [ Designated as safety issue: No ]
    Quality of Life improvement from day 0 to week 12 or closure using the Diabetic Foot Ulcer Scale - Short form

  • Epithelial tissue development [ Time Frame: week 12 or wound closure ] [ Designated as safety issue: No ]
    Epithelial tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score

  • Granulation tissue development [ Time Frame: week 12 or wound closure ] [ Designated as safety issue: No ]
    Granulation tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score

  • Total Bates-Jensen Wound Assessment Tool Score [ Time Frame: week 12 or wound closure ] [ Designated as safety issue: No ]
    Total Bates-Jensen Wound Assessment Tool Score from day 0 to week 12 or closure


Estimated Enrollment: 110
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CDO with standard MWT
CDO (continuously supply pure oxygen) with standard Moist Wound Therapy
Device: CDO electrochemical tissue oxygenation system
The TransCu O2® device is a non-invasive, electrochemical tissue oxygenation system intended for use with lower-cost wound dressings for the treatment of chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers and other skin wounds through the continuous diffusion of oxygen (CDO). The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing
Other Names:
  • TransCu O2® device
  • CDO Therapy
Sham Comparator: Moist Wound Therapy
Moist Wound Therapy. De-activated Sham device placed to wound in order to blind patient and study staff.
Device: Moist Wound Therapy
Moist Wound Therapy in combination with sham or deactivated device

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 30-90 years of age at the time of Informed Consent
  • Subjects with type 1 or type 2 Diabetes Mellitus with a non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers
  • Subjects who have an ulcer with a duration of at least 4 weeks, but not greater than 52 weeks at time of screening
  • Subjects with an index ulcer measuring between 1 - 10 cm2 in area after debridement (Area = length x width)
  • Subjects with a diabetic foot ulcer(s) at or below the malleoli
  • Subjects who demonstrates adequate arterial perfusion defined as either:

    • transcutaneous oxygen measurements of the dorsum of the foot > 30 mm Hg with a skin perfusion pressure > 30 mm Hg, or an ankle/brachial index (ABI) above 0.7, with documented confirmation of adequate arterial perfusion, or
    • a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening, or
    • absolute toe pressure of > 30 mm Hg
  • Subject and/or caregiver must be able and willing to learn and perform the duties of dressing changes
  • Subjects are able and willing to comply with standardized off-loading regimen (such as a fixed ankle walker)

Exclusion Criteria:

  • Subjects < 30 or > 90 years of age at the time of Informed Consent

    • Subjects with Target Ulcers with a duration < 4 weeks or > 52 weeks
    • Subjects with ulcers measuring less than 1 cm2 or greater than 10 cm2 in area (Area = length x width) after debridement at the time of screening
    • Subjects whose ulcer decreased in area by > 30 % during the 1 week screening period
    • Subjects with evidence of gangrene on any part of affected limb
    • Subjects with active Charcot's foot on the study limb
    • Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment
    • Subjects with active infection at the time of screening
    • Subjects with a target ulcer which has exposed tendons, ligaments, muscle, or bone
    • Subjects with active malignancy, excluding non-melanoma skin cancer
    • Subjects with a history of malignancy on study limb
    • Subjects in whom oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline
    • Subjects who are currently receiving or has received radiation or chemotherapy within 3 months of randomization
    • Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening
    • Subjects who are pregnant at the time of screening
    • Subjects who are undergoing active renal dialysis
    • Subjects who have a known immune insufficiency, excluding Diabetes Mellitus
    • Subjects with a history of peripheral vascular repair within 14 days of screening
    • Subjects with a current deep vein thrombosis (DVT)
    • Subjects with ulcers due to Raynaud's disease
    • Subjects with and ulcer due to acute thrombophlebitis
    • Subjects with inadequate perfusion to support healing
    • Subjects with necrotic wounds covered with eschar or slough
    • Subjects with wounds with fistulae or deep sinus tracts of unknown depth
    • Subjects who are receiving palliative care
    • Subjects who have a HbA1c > 12% (uncontrolled hyperglycemia)
    • Subjects whose target ulcer has a known etiology of: malignancy, burn, collagen vascular disease, sickle cell, vasculopathy, or pyoderma gangrenosum
    • Subjects with a documented history of alcohol or substance abuse within 6 months of screening
    • Subjects who are currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results
    • Subjects with a known allergy to dressing materials, including occlusive dressings and the adhesives on such dressings
  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: NCT01645891

Locations
United States, Arizona
Clinical Trials of Texas, Inc., dba Clinical Trials of Arizona, Inc.
Glendale, Arizona, United States, 85306
Associated Foot and Ankle Specialists
Phoenix, Arizona, United States, 85015
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, California
Roy O. Kroeker, DPM , Inc.
Fresno, California, United States, 93710
United States, Florida
Doctors Research Network
South Miami, Florida, United States, 33143
United States, Maryland
Foot and Ankle Specialists of the Mid-Atlantic
Annapolis, Maryland, United States, 21401
Foot and Ankle Specialists of the Mid-Atlantic
Kensington, Maryland, United States, 20895
Foot and Ankle Specialists of the Mid-Atlantic
Pasadena, Maryland, United States, 21122
United States, North Carolina
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, Texas
Richard C. Galperin, DPM, PA
Dallas, Texas, United States, 75224
William Blake Partners, LLC
Grapevine, Texas, United States, 76051
Complete Family Foot Care
McAllen, Texas, United States, 78501
Alamo Clinical Research
San Antonio, Texas, United States, 78212
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Electrochemical Oxygen Concepts, Inc.
Investigators
Principal Investigator: David G Armstrong, DPM, MD, PhD Southern Arizona Limb Salvage Alliance (SALSA)
  More Information

Responsible Party: Electrochemical Oxygen Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01645891     History of Changes
Other Study ID Numbers: TC02-2012-01 
Study First Received: July 18, 2012
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Electrochemical Oxygen Concepts, Inc.:
Diabetic Foot Ulcer

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases

ClinicalTrials.gov processed this record on December 02, 2016