A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT01645891

Run by

Electrochemical Oxygen Concepts, Inc.

People needed

146

Starts

2012-04-01

Expected to finish

2016-11-01

Last updated by the study team

2024-10-01

Who can join

Age: 30 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Clinical Trials of Texas, Inc., dba Clinical Trials of Arizona, Inc. — Glendale, Arizona, United States
• Associated Foot and Ankle Specialists — Phoenix, Arizona, United States
• Premier Foot & Ankle Surgeons — Tucson, Arizona, United States
• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• Sacramento Foot & Ankle Center — Fair Oaks, California, United States
• Roy O. Kroeker, DPM , Inc. — Fresno, California, United States
• Limb Preservation Platform — Fresno, California, United States
• Center for Clinical Research, Inc — San Francisco, California, United States
• The Research Center — Hialeah, Florida, United States
• Phoenix Medical Research — Miami, Florida, United States
• Doctors Research Network — South Miami, Florida, United States
• Orthopedic Research Institute — West Palm Beach, Florida, United States
• Aiyan Diabetes Center — Martinez, Georgia, United States
• Weil Foot & Ankle Institute — Chicago, Illinois, United States
• Weil Foot & Ankle Institute — Des Plaines, Illinois, United States
• Foot and Ankle Specialists of the Mid-Atlantic — Annapolis, Maryland, United States
• Foot and Ankle Specialists of the Mid-Atlantic — Kensington, Maryland, United States
• Foot and Ankle Specialists of the Mid-Atlantic — Pasadena, Maryland, United States
• Clinical Research Medical Center — Las Vegas, Nevada, United States
• Impact Clinical Trials — Las Vegas, Nevada, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Clinical Research Associates of Central PA — Altoona, Pennsylvania, United States
• Foot and Ankle Center — Haverford, Pennsylvania, United States
• Integrated Clinical Research — Abilene, Texas, United States

Full record on ClinicalTrials.gov

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