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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: CDO electrochemical tissue oxygenation system
* Device: Moist Wound Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CDO with standard MWT<br>CDO (continuously supply pure oxygen) with standard Moist Wound Therapy | Device: CDO electrochemical tissue oxygenation system<br>* 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<br>* Other names: CDO Therapy;|
| Sham Comparator: Moist Wound Therapy<br>Moist Wound Therapy. De-activated Sham device placed to wound in order to blind patient and study staff. | Device: Moist Wound Therapy<br>* Moist Wound Therapy in combination with sham or deactivated device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain Reduction | Pain Reduction from day 0 to week 12 or closure using the Wong-Baker Faces™ Pain Rating Scale | 12 weeks or closure | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer