A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
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
1 other identifier
interventional
146
1 country
33
Brief Summary
The purpose of this study was 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
October 1, 2024
CompletedOctober 1, 2024
September 1, 2024
4.6 years
July 18, 2012
August 12, 2020
September 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Complete (100%) Wound Closure Defined as Complete Re-epithelialization Without Drainage
Number of Participants with complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12
12 weeks or wound closure
Secondary Outcomes (3)
Time to 50% Wound Closure
12 weeks or wound closure
Time to 75% Wound Closure
12 weeks or wound closure
Time to 100% Wound Closure
12 weeks or wound closure
Study Arms (2)
CDO with standard MWT
ACTIVE COMPARATORCDO (continuously supply pure oxygen) with standard Moist Wound Therapy
Moist Wound Therapy
SHAM COMPARATORMoist Wound Therapy. De-activated Sham device placed to wound in order to blind patient and study staff.
Interventions
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 in combination with sham or deactivated device
Eligibility Criteria
You may qualify if:
- 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 1.5 - 10 cm2 in area after debridement (Area = length x width) at time of Screening 1 and Screening 2, as measured using digital photography \& computerized planimetric analysis by Centralized Wound Measuring Center (CWMC)
- 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)
You may not qualify if:
- 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 1.5 cm2 or greater than 10 cm2 in area (Area = length x width) after debridement at the time of Screening 1 and Screening 2 to Randomization) or \> 50% during the 2 week screening period, as measured using digital photography \& computerized planimetric analysis's determined by CWMC.
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Clinical Trials of Texas, Inc., dba Clinical Trials of Arizona, Inc.
Glendale, Arizona, 85306, United States
Associated Foot and Ankle Specialists
Phoenix, Arizona, 85015, United States
Premier Foot & Ankle Surgeons
Tucson, Arizona, 85712, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Sacramento Foot & Ankle Center
Fair Oaks, California, 95628, United States
Roy O. Kroeker, DPM , Inc.
Fresno, California, 93710, United States
Limb Preservation Platform
Fresno, California, 93721, United States
Center for Clinical Research, Inc
San Francisco, California, 94115, United States
The Research Center
Hialeah, Florida, 33013, United States
Phoenix Medical Research
Miami, Florida, 33165, United States
Doctors Research Network
South Miami, Florida, 33143, United States
Orthopedic Research Institute
West Palm Beach, Florida, 33406, United States
Aiyan Diabetes Center
Martinez, Georgia, 30907, United States
Weil Foot & Ankle Institute
Chicago, Illinois, 60616, United States
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016, United States
Foot and Ankle Specialists of the Mid-Atlantic
Annapolis, Maryland, 21401, United States
Foot and Ankle Specialists of the Mid-Atlantic
Kensington, Maryland, 20895, United States
Foot and Ankle Specialists of the Mid-Atlantic
Pasadena, Maryland, 21122, United States
Clinical Research Medical Center
Las Vegas, Nevada, 89106, United States
Impact Clinical Trials
Las Vegas, Nevada, 89106, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Clinical Research Associates of Central PA
Altoona, Pennsylvania, 16602, United States
Foot and Ankle Center
Haverford, Pennsylvania, 19041, United States
Integrated Clinical Research
Abilene, Texas, 79606, United States
Richard C. Galperin, DPM, PA
Dallas, Texas, 75224, United States
William Blake Partners, LLC
Grapevine, Texas, 76051, United States
Houston Foot & Ankle
Houston, Texas, 77074, United States
Complete Family Foot Care
McAllen, Texas, 78501, United States
Alamo Clinical Research
San Antonio, Texas, 78212, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Clinical Research Medical Center
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mark Q Niederauer
- Organization
- EO2 Concepts
Study Officials
- PRINCIPAL INVESTIGATOR
David G Armstrong, DPM, MD, PhD
Southern Arizona Limb Salvage Alliance (SALSA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
July 18, 2012
First Posted
July 20, 2012
Study Start
April 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
October 1, 2024
Results First Posted
October 1, 2024
Record last verified: 2024-09