Trial Outcomes & Findings for A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs (NCT NCT01645891)
NCT ID: NCT01645891
Last Updated: 2024-10-01
Results Overview
Number of Participants with complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
12 weeks or wound closure
Results posted on
2024-10-01
Participant Flow
Patients were monitored for 2 weeks with SOC prior to randomization. Subjects with wounds that failed inclusion/exclusion criteria or closed too quickly (non-chronic) via planimetric analysis were excluded or removed from the study. Of 386 screened patients, 146 met inclusion criteria and participated in the treatment phase.
Participant milestones
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
72
|
|
Overall Study
COMPLETED
|
52
|
53
|
|
Overall Study
NOT COMPLETED
|
22
|
19
|
Reasons for withdrawal
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
10
|
|
Overall Study
Adverse Event Unrelated to Wound
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
This measure depicts whether the participant had a pain score of zero (0) on a scale of 0-10 at the baseline visit. There was one participant in each arm (2 total) for which a baseline pain score was not recorded. Therefore the total number of participants with pain scores does not match the total number of participants: the total with pain scores at baseline is 144 whereas the total number of participants is 146.
Baseline characteristics by cohort
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
n=74 Participants
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
n=72 Participants
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 Years
STANDARD_DEVIATION 10.1 • n=74 Participants
|
56.6 Years
STANDARD_DEVIATION 14.4 • n=72 Participants
|
56.3 Years
STANDARD_DEVIATION 12.4 • n=146 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=74 Participants
|
18 Participants
n=72 Participants
|
33 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=74 Participants
|
54 Participants
n=72 Participants
|
113 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=74 Participants
|
29 Participants
n=72 Participants
|
55 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=74 Participants
|
43 Participants
n=72 Participants
|
90 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=74 Participants
|
12 Participants
n=72 Participants
|
25 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=74 Participants
|
60 Participants
n=72 Participants
|
120 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=74 Participants
|
72 participants
n=72 Participants
|
146 participants
n=146 Participants
|
|
Wound Area, cm^2 ± SD
|
3.54 cm^2
STANDARD_DEVIATION 1.68 • n=74 Participants
|
3.89 cm^2
STANDARD_DEVIATION 2.02 • n=72 Participants
|
3.71 cm^2
STANDARD_DEVIATION 1.85 • n=146 Participants
|
|
Wound Age, days ± SD
|
131.6 years
STANDARD_DEVIATION 89.2 • n=74 Participants
|
143.8 years
STANDARD_DEVIATION 97.7 • n=72 Participants
|
137.6 years
STANDARD_DEVIATION 93.4 • n=146 Participants
|
|
Hemoglobin A1C (HbA1c) ± SD
|
8.4 %
STANDARD_DEVIATION 1.6 • n=74 Participants
|
8.3 %
STANDARD_DEVIATION 2 • n=72 Participants
|
8.3 %
STANDARD_DEVIATION 1.8 • n=146 Participants
|
|
Ankle Brachial Index (ABI) ± SD
|
1.05 index units
STANDARD_DEVIATION .14 • n=74 Participants
|
1.02 index units
STANDARD_DEVIATION .15 • n=72 Participants
|
1.03 index units
STANDARD_DEVIATION .15 • n=146 Participants
|
|
Participants with Wound Weight Bearing Surface
|
59 participants
n=74 Participants
|
53 participants
n=72 Participants
|
112 participants
n=146 Participants
|
|
Participants with No Wound Pain at Baseline
|
32 Participants
n=73 Participants • This measure depicts whether the participant had a pain score of zero (0) on a scale of 0-10 at the baseline visit. There was one participant in each arm (2 total) for which a baseline pain score was not recorded. Therefore the total number of participants with pain scores does not match the total number of participants: the total with pain scores at baseline is 144 whereas the total number of participants is 146.
|
26 Participants
n=71 Participants • This measure depicts whether the participant had a pain score of zero (0) on a scale of 0-10 at the baseline visit. There was one participant in each arm (2 total) for which a baseline pain score was not recorded. Therefore the total number of participants with pain scores does not match the total number of participants: the total with pain scores at baseline is 144 whereas the total number of participants is 146.
|
58 Participants
n=144 Participants • This measure depicts whether the participant had a pain score of zero (0) on a scale of 0-10 at the baseline visit. There was one participant in each arm (2 total) for which a baseline pain score was not recorded. Therefore the total number of participants with pain scores does not match the total number of participants: the total with pain scores at baseline is 144 whereas the total number of participants is 146.
|
|
Participants with Wound Pain at Baseline
|
41 Participants
n=73 Participants • There was one participant in each arm (2 total) for which a baseline pain score was not recorded. Therefore the total number of participants with pain scores does not match the total number of participants: the total with pain scores at baseline is 144 whereas the total number of participants is 146.
|
45 Participants
n=71 Participants • There was one participant in each arm (2 total) for which a baseline pain score was not recorded. Therefore the total number of participants with pain scores does not match the total number of participants: the total with pain scores at baseline is 144 whereas the total number of participants is 146.
|
86 Participants
n=144 Participants • There was one participant in each arm (2 total) for which a baseline pain score was not recorded. Therefore the total number of participants with pain scores does not match the total number of participants: the total with pain scores at baseline is 144 whereas the total number of participants is 146.
|
PRIMARY outcome
Timeframe: 12 weeks or wound closurePopulation: Subjects who completed the study.
Number of Participants with complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12
Outcome measures
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
n=52 Participants
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
n=53 Participants
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
|---|---|---|
|
Number of Participants With Complete (100%) Wound Closure Defined as Complete Re-epithelialization Without Drainage
|
24 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 weeks or wound closurePopulation: All eligible patients, including patients who dropped from the study, were analyzed for time (in days) to reach 50%, 75% and 100% wound closure via planimetric analysis.
Time to 50% wound closure by using digital photography \& computerized planimetric analysis
Outcome measures
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
n=74 Participants
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
n=72 Participants
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
|---|---|---|
|
Time to 50% Wound Closure
|
18.45 days
Standard Deviation 16.32
|
28.9 days
Standard Deviation 22.54
|
SECONDARY outcome
Timeframe: 12 weeks or wound closurePopulation: All eligible patients, including patients who dropped from the study, were analyzed for time (in days) to reach 50%, 75% and 100% wound closure via planimetric analysis.
Time to 75% wound closure by using digital photography \& computerized planimetric analysis
Outcome measures
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
n=74 Participants
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
n=72 Participants
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
|---|---|---|
|
Time to 75% Wound Closure
|
27.8 days
Standard Deviation 19.89
|
40 days
Standard Deviation 15.46
|
SECONDARY outcome
Timeframe: 12 weeks or wound closurePopulation: All eligible patients, including patients who dropped from the study, were analyzed for time (in days) to reach 50%, 75% and 100% wound closure via planimetric analysis.
Time to 100% wound closure by using digital photography \& computerized planimetric analysis
Outcome measures
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
n=74 Participants
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
n=72 Participants
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
|---|---|---|
|
Time to 100% Wound Closure
|
49 days
Standard Deviation 18.17
|
59.5 days
Standard Deviation 21.22
|
Adverse Events
Active Arm - Moist Wound Therapy With Active CDO Device
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Arm - Moist Wound Therapy With Sham CDO Device
Serious events: 0 serious events
Other events: 13 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Arm - Moist Wound Therapy With Active CDO Device
n=74 participants at risk
CDO (Continuous Diffusion of Oxygen) with standard Moist Wound Therapy. 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 CDO. The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing. The active arm is basically moist wound therapy plus a continuous infusion of pure, humidified oxygen. Dressings, offloading and standard of care are identical in both arms.
|
Placebo Arm - Moist Wound Therapy With Sham CDO Device
n=72 participants at risk
Moist Wound Therapy with Sham CDO Device. A fully functional sham device is used in order to blind patient and study staff. The sham device is functional, producing oxygen and identical to active device with the exception that the oxygen diverted within the device and no oxygen was delivered to the wound bed. Thus, the placebo arm appears identical to the the active arm with the goal of achieving full study blinding. Dressings, offloading and standard of care are identical in both arms.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Infection
|
8.1%
6/74 • Number of events 6 • 24 weeks
|
13.9%
10/72 • Number of events 10 • 24 weeks
|
|
Social circumstances
Traffic accident
|
1.4%
1/74 • Number of events 1 • 24 weeks
|
0.00%
0/72 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Osteomyelitis
|
1.4%
1/74 • Number of events 1 • 24 weeks
|
0.00%
0/72 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
New Abcess
|
1.4%
1/74 • Number of events 1 • 24 weeks
|
0.00%
0/72 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/74 • 24 weeks
|
1.4%
1/72 • Number of events 1 • 24 weeks
|
|
Social circumstances
Drug Overdose
|
0.00%
0/74 • 24 weeks
|
1.4%
1/72 • Number of events 1 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Infection, Abscess, Cellulitis
|
0.00%
0/74 • 24 weeks
|
1.4%
1/72 • Number of events 1 • 24 weeks
|
|
Blood and lymphatic system disorders
Arterial Stenosis
|
2.7%
2/74 • Number of events 2 • 24 weeks
|
0.00%
0/72 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place