Diabetic Foot UlcerNCT01645891
A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
A study testing CDO electrochemical tissue oxygenation system and Moist Wound Therapy in people with Diabetic Foot Ulcer, run by Electrochemical Oxygen Concepts, Inc. at 33 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- CDO electrochemical tissue oxygenation system and Moist Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 33 sitesUnited States
- Study dates
- Apr 2012to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Integrated Clinical Research
Abilene, Texas, 79606
Clinical Research Associates of Central PA
Altoona, Pennsylvania, 16602
Foot and Ankle Specialists of the Mid-Atlantic
Annapolis, Maryland, 21401
Weil Foot & Ankle Institute
Chicago, Illinois, 60616
Richard C. Galperin, DPM, PA
Dallas, Texas, 75224
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016
Sacramento Foot & Ankle Center
Fair Oaks, California, 95628
Roy O. Kroeker, DPM , Inc.
Fresno, California, 93710
Limb Preservation Platform
Fresno, California, 93721
Clinical Trials of Texas, Inc., dba Clinical Trials of Arizona, Inc.
Glendale, Arizona, 85306
William Blake Partners, LLC
Grapevine, Texas, 76051
Foot and Ankle Center
Haverford, Pennsylvania, 19041
The Research Center
Hialeah, Florida, 33013
Houston Foot & Ankle
Houston, Texas, 77074
Foot and Ankle Specialists of the Mid-Atlantic
Kensington, Maryland, 20895
Clinical Research Medical Center
Las Vegas, Nevada, 89106
Impact Clinical Trials
Las Vegas, Nevada, 89106
Aiyan Diabetes Center
Martinez, Georgia, 30907
Complete Family Foot Care
McAllen, Texas, 78501
Phoenix Medical Research
Miami, Florida, 33165
Foot and Ankle Specialists of the Mid-Atlantic
Pasadena, Maryland, 21122
Associated Foot and Ankle Specialists
Phoenix, Arizona, 85015
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Clinical Research Medical Center
Salt Lake City, Utah, 84107
Alamo Clinical Research
San Antonio, Texas, 78212
Clinical Trials of Texas
San Antonio, Texas, 78229
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Center for Clinical Research, Inc
San Francisco, California, 94115
Doctors Research Network
South Miami, Florida, 33143
Premier Foot & Ankle Surgeons
Tucson, Arizona, 85712
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Orthopedic Research Institute
West Palm Beach, Florida, 33406
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
About this study
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
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.
Read the detailed description
This study was a 12-week, randomized, fully blinded, placebo-controlled, parallel group clinical trial evaluating the use of the CDO device for DFUs. The CDO device used was the TransCu O2 System. The study was approved by the Schulman Associates Institutional Review Board (Cincinnati, OH, IRB No. 201202439). Randomisation lists were made by the statistician for each clinical site in blocks of size four with SAS. Devices were labelled by the statistician before shipping to the sites. The sites assigned devices to patients sequentially at randomisation. Both arms received identical treatment (device, dressings, etc.) and the devices were functional in both arms with the exception that the oxygen did not flow to the ulcer in the placebo arm. All devices were functional in that they produced oxygen and displayed the oxygen flow rate. This had the effect that the devices appeared identical, including battery drain and oxygen flow display. The only difference was that the placebo devices did not have any oxygen flowing out of the oxygen supply port. Since the oxygen flow rate (3ml/ hour) is low enough that it cannot be felt by the subjects or physicians, the devices all appeared identical. Similarly, the dressings and offloading boots in each arm were limited and identical. The result was that the patients, doctors, evaluators, sponsor and statistician were all fully-blinded to the treatment arms until the data had been collected and verified, thereby eliminating the placebo effect.
Before assignment of a device, all patients were subjected to a run-in period during which they received standard of care dressings, debridement and off-loading to ensure that the wounds were indeed chronic in nature. There were two inclusion criteria essential to the design of the study to ensure that only chronic wounds were being included: initial or baseline wound size and initial or run-in rate of wound closure. These were defined as: 1) baseline DFU size: the ulcer area as determined by independently-verified digital planimetric analysis during screening through the randomization visit, and 2) run-in ulcer closure rate: the percentage of ulcer closure (percentage wound area reduction, or PWAR) during the run-in period before the placement of the device. All subjects received MWT during the run-in period.
The intent was to find a balance between a short run-in period and robust screening criteria to help ensure that non-chronic wounds were not included in the study. Since the PWAR assessment relied on independently-verified planimetric analysis of wound photos, some subjects were initially placed on a device at the conclusion of the run-in period and subsequently found to be not eligible for failing study inclusion/ exclusion criteria. These subjects were removed as not eligible.
The primary efficacy outcome was complete wound closure, defined as complete re-epithelialization with no drainage as assessed by the treating clinician and confirmed by a blinded observer.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- CDO electrochemical tissue oxygenation system, Moist Wound Therapy
- Keywords
- Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDO electrochemical tissue oxygenation systemDevice
Also called TransCu O2® device, CDO Therapy
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 TherapyDevice
Moist Wound Therapy in combination with sham or deactivated device
| Study group | Role | What they receive |
|---|---|---|
| CDO with standard MWT | Active comparator | CDO (continuously supply pure oxygen) with standard Moist Wound Therapy Receives: Device: CDO electrochemical tissue oxygenation system |
| Moist Wound Therapy | Sham comparator | Moist Wound Therapy. De-activated Sham device placed to wound in order to blind patient and study staff. Receives: Device: Moist Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks or wound closure
Secondary outcomes (3)
Time to 50% Wound Closure
Time to 50% wound closure by using digital photography \& computerized planimetric analysis
Measured: 12 weeks or wound closure
Time to 75% Wound Closure
Time to 75% wound closure by using digital photography \& computerized planimetric analysis
Measured: 12 weeks or wound closure
Time to 100% Wound Closure
Time to 100% wound closure by using digital photography \& computerized planimetric analysis
Measured: 12 weeks or wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electrochemical Oxygen Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G Armstrong, DPM, MD, PhD, Principal investigator, Southern Arizona Limb Salvage Alliance (SALSA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645891
- Sponsor's protocol ID
- TC02-2012-01
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2012
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01645891
- Acronym / sponsor ID
- TC02-2012-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Electrochemical Oxygen Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was a 12-week, randomized, fully blinded, placebo-controlled, parallel group clinical trial evaluating the use of the CDO device for DFUs. The CDO device used was the TransCu O2 System. The study was approved by the Schulman Associates Institutional Review Board (Cincinnati, OH, IRB No. 201202439). Randomisation lists were made by the statistician for each clinical site in blocks of size four with SAS. Devices were labelled by the statistician before shipping to the sites. The sites assigned devices to patients sequentially at randomisation. Both arms received identical treatment (device, dressings, etc.) and the devices were functional in both arms with the exception that the oxygen did not flow to the ulcer in the placebo arm. All devices were functional in that they produced oxygen and displayed the oxygen flow rate. This had the effect that the devices appeared identical, including battery drain and oxygen flow display. The only difference was that the placebo devices did not have any oxygen flowing out of the oxygen supply port. Since the oxygen flow rate (3ml/ hour) is low enough that it cannot be felt by the subjects or physicians, the devices all appeared identical. Similarly, the dressings and offloading boots in each arm were limited and identical. The result was that the patients, doctors, evaluators, sponsor and statistician were all fully-blinded to the treatment arms until the data had been collected and verified, thereby eliminating the placebo effect.
Before assignment of a device, all patients were subjected to a run-in period during which they received standard of care dressings, debridement and off-loading to ensure that the wounds were indeed chronic in nature. There were two inclusion criteria essential to the design of the study to ensure that only chronic wounds were being included: initial or baseline wound size and initial or run-in rate of wound closure. These were defined as: 1) baseline DFU size: the ulcer area as determined by independently-verified digital planimetric analysis during screening through the randomization visit, and 2) run-in ulcer closure rate: the percentage of ulcer closure (percentage wound area reduction, or PWAR) during the run-in period before the placement of the device. All subjects received MWT during the run-in period.
The intent was to find a balance between a short run-in period and robust screening criteria to help ensure that non-chronic wounds were not included in the study. Since the PWAR assessment relied on independently-verified planimetric analysis of wound photos, some subjects were initially placed on a device at the conclusion of the run-in period and subsequently found to be not eligible for failing study inclusion/ exclusion criteria. These subjects were removed as not eligible.
The primary efficacy outcome was complete wound closure, defined as complete re-epithelialization with no drainage as assessed by the treating clinician and confirmed by a blinded observer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDO with standard MWT | Active comparator | Device: CDO electrochemical tissue oxygenation systemCDO (continuously supply pure oxygen) with standard Moist Wound Therapy |
| Moist Wound Therapy | Sham comparator | Device: Moist Wound TherapyMoist Wound Therapy. De-activated Sham device placed to wound in order to blind patient and study staff. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (30 listed)
- Subjects < 30 or > 90 years of age at the time of Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDO electrochemical tissue oxygenation systemAlso: TransCu O2® device, CDO TherapyThe 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 | Device | CDO with standard MWT |
| Moist Wound TherapyMoist Wound Therapy in combination with sham or deactivated device | Device | Moist Wound Therapy |
Primary outcome
Number of Participants With Complete (100%) Wound Closure Defined as Complete Re-epithelialization Without Drainage
Time frame: 12 weeks or wound closure
Number of Participants with complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12
3 secondary outcomes
Time to 50% Wound Closure
Time frame: 12 weeks or wound closure
Time to 75% Wound Closure
Time frame: 12 weeks or wound closure
Time to 100% Wound Closure
Time frame: 12 weeks or wound closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
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Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Armstrong, DPM, MD, PhD principal investigator
Southern Arizona Limb Salvage Alliance (SALSA)
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDO electrochemical tissue oxygenation system and Moist Wound Therapy in people with Diabetic Foot Ulcer, run by Electrochemical Oxygen Concepts, Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete (100%) Wound Closure Defined as Complete Re-epithelialization Without Drainage (time frame: 12 weeks or wound closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.