Trial Outcomes & Findings for Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia (NCT NCT02046226)
NCT ID: NCT02046226
Last Updated: 2015-10-12
Results Overview
Percentage reduction in target wound area (length x width).
TERMINATED
NA
7 participants
3 months
2015-10-12
Participant Flow
The randomization of subjects to either of the two treatments (OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care) in this study was not indicated on each of the case report forms of the seven subjects enrolled.
Participant milestones
| Measure |
All Study Participants
The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
All Study Participants
The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
Baseline characteristics by cohort
| Measure |
All Study Participants
n=7 Participants
The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
|
|---|---|
|
Age, Categorical
<=18 years
|
NA Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
NA Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Study subjects were not available to provide data when the primary outcome was to be reported, and thus there are no primary outcome data to report.
Percentage reduction in target wound area (length x width).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Study subjects were not available to provide data when the secondary outcome was to be reported, and thus there are no secondary outcome data to report.
number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks.
Outcome measures
Outcome data not reported
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee An agreement between Sponsor and Investigator(s) in the final form of abstracts and articles shall be obtained within an appropriate time frame of 60 days. Any and all information supplied or obtained during this study by or on behalf of any party involved in the study (in whatever form) shall be treated as confidential, shall not be disclosed to any third party unless with the prior written consent of the Sponsor in each case.
- Publication restrictions are in place
Restriction type: OTHER