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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645891
• Other study ID #: TC02-2012-01
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: February 8, 2017
• Start date: April 2012
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Electrochemical Oxygen Concepts, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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
• Moist Wound Therapy
Moist Wound Therapy in combination with sham or deactivated device

Locations

Country	Name	City	State
United States	Clinical Research Associates of Central PA	Altoona	Pennsylvania
United States	Foot and Ankle Specialists of the Mid-Atlantic	Annapolis	Maryland
United States	Richard C. Galperin, DPM, PA	Dallas	Texas
United States	Sacramento Foot & Ankle Center	Fair Oaks	California
United States	Limb Preservation Platform	Fresno	California
United States	Roy O. Kroeker, DPM , Inc.	Fresno	California
United States	Clinical Trials of Texas, Inc., dba Clinical Trials of Arizona, Inc.	Glendale	Arizona
United States	William Blake Partners, LLC	Grapevine	Texas
United States	The Research Center	Hialeah	Florida
United States	Houston Foot & Ankle	Houston	Texas
United States	Foot and Ankle Specialists of the Mid-Atlantic	Kensington	Maryland
United States	Clinical Research Medical Center	Las Vegas	Nevada
United States	Aiyan Diabetes Center	Martinez	Georgia
United States	Complete Family Foot Care	McAllen	Texas
United States	Phoenix Medical Research	Miami	Florida
United States	Foot and Ankle Specialists of the Mid-Atlantic	Pasadena	Maryland
United States	Associated Foot and Ankle Specialists	Phoenix	Arizona
United States	Alamo Clinical Research	San Antonio	Texas
United States	Clinical Trials of Texas	San Antonio	Texas
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Center for Clinical Research, Inc	San Francisco	California
United States	Doctors Research Network	South Miami	Florida
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Orthopedic Research Institute	West Palm Beach	Florida
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Electrochemical Oxygen Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete (100%) wound closure defined as complete re-epithelialization without drainage	Complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12	12 weeks or wound closure
Secondary	Time to 50%, 75% and 100% wound closure	Time to 50%, 75% and 100% wound closure by using digital photography & computerized planimetric analysis	12 weeks or wound closure
Secondary	Pain Reduction	Pain Reduction from day 0 to week 12 or closure using the Wong-Baker Faces™ Pain Rating Scale	12 weeks or closure
Secondary	Quality of Life	Quality of Life improvement from day 0 to week 12 or closure using the Diabetic Foot Ulcer Scale - Short form	week 12 or wound closure
Secondary	Epithelial tissue development	Epithelial tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score	week 12 or wound closure
Secondary	Granulation tissue development	Granulation tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score	week 12 or wound closure
Secondary	Total Bates-Jensen Wound Assessment Tool Score	Total Bates-Jensen Wound Assessment Tool Score from day 0 to week 12 or closure	week 12 or wound closure