Trial Outcomes & Findings for Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers (NCT NCT01291160)
NCT ID: NCT01291160
Last Updated: 2014-05-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
130 participants
Primary outcome timeframe
before or at week 12
Results posted on
2014-05-13
Participant Flow
Participant milestones
| Measure |
Epiflo Treatment
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
Sham Device
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
64
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Epiflo Treatment
n=66 Participants
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
Sham Device
n=64 Participants
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.25 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
58.46 years
STANDARD_DEVIATION 9.53 • n=7 Participants
|
59.25 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: before or at week 12Population: Analyzed the per-protocol population
Outcome measures
| Measure |
Epiflo Treatment
n=61 Participants
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
Sham Device
n=61 Participants
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
|---|---|---|
|
Number of 100% Wound Closure
|
55.74 percentage of patients
|
50.82 percentage of patients
|
Adverse Events
Epiflo Treatment
Serious events: 10 serious events
Other events: 37 other events
Deaths: 0 deaths
Sham Device
Serious events: 9 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epiflo Treatment
n=66 participants at risk
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
Sham Device
n=64 participants at risk
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
1.5%
1/66 • Number of events 1
|
4.7%
3/64 • Number of events 3
|
|
Infections and infestations
Wound Infection
|
1.5%
1/66 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Abscess limb
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Burn
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/66
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/66
|
1.6%
1/64 • Number of events 1
|
|
Surgical and medical procedures
amputation
|
0.00%
0/66
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Localised infection
|
1.5%
1/66 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/66
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Streptococcal bacteraemia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/66
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
Epiflo Treatment
n=66 participants at risk
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.
Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
Sham Device
n=64 participants at risk
The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.
Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Abrasions
|
3.0%
2/66 • Number of events 2
|
7.8%
5/64 • Number of events 6
|
|
Infections and infestations
Cellulitis
|
1.5%
1/66 • Number of events 1
|
4.7%
3/64 • Number of events 3
|
|
Vascular disorders
Diabetic ulcer
|
7.6%
5/66 • Number of events 8
|
4.7%
3/64 • Number of events 3
|
|
General disorders
Edema
|
1.5%
1/66 • Number of events 2
|
6.2%
4/64 • Number of events 4
|
|
Infections and infestations
Wound Infection
|
3.0%
2/66 • Number of events 2
|
4.7%
3/64 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound complication
|
45.5%
30/66 • Number of events 52
|
50.0%
32/64 • Number of events 55
|
|
Infections and infestations
Wound infection
|
4.5%
3/66 • Number of events 3
|
7.8%
5/64 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place