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



Status:Completed
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:30 - 90
Updated:2/10/2017
Start Date:April 2012
End Date:November 2016

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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

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.


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
We found this trial at
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Altoona, Pennsylvania 16602
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Dallas, Texas 75224
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Fair Oaks, California 95628
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Fresno, California 93710
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Fresno, California 93721
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Grapevine, Texas 76051
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Hialeah, Florida 33016
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7777 Southwest Freeway
Houston, Texas 77074
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1012 East Sahara Avenue
Las Vegas, Nevada 89106
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462 Furys Ferry Road
Martinez, Georgia 30907
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McAllen, Texas 78501
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Miami, Florida 33165
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San Antonio, Texas 78212
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San Francisco, California 94115
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South Miami, Florida 33143
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1501 Forest Hill Boulevard
West Palm Beach, Florida 33406
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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