Trial Outcomes & Findings for Study of Oasis Ultra in Diabetic Foot Ulcers (NCT NCT01835379)
NCT ID: NCT01835379
Last Updated: 2015-01-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
At the end of 12 Weeks
Results posted on
2015-01-22
Participant Flow
Participant milestones
| Measure |
Oasis
Oasis
Oasis Ultra applied once per week for up to 12 weeks.
|
Standard
Standard Care
Standard Care as chosen by the Investigator
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Oasis Ultra in Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Oasis
n=41 Participants
Oasis
Oasis Ultra applied once per week for up to 12 weeks.
|
Standard
n=41 Participants
Standard Care
Standard Care as chosen by the Investigator
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.9 kg/m2
STANDARD_DEVIATION 8.9 • n=5 Participants
|
33.6 kg/m2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
33.3 kg/m2
STANDARD_DEVIATION 7.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of 12 WeeksOutcome measures
| Measure |
Oasis
n=41 Participants
Oasis
Oasis Ultra applied once per week for up to 12 weeks.
|
Standard
n=41 Participants
Standard Care
Standard Care as chosen by the Investigator
|
|---|---|---|
|
Percentage of Wounds Closed
|
54 percentage of wounds closed
|
32 percentage of wounds closed
|
SECONDARY outcome
Timeframe: During the 12 Week treatment periodKaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.
Outcome measures
| Measure |
Oasis
n=41 Participants
Oasis
Oasis Ultra applied once per week for up to 12 weeks.
|
Standard
n=41 Participants
Standard Care
Standard Care as chosen by the Investigator
|
|---|---|---|
|
Time to Wound Closure
|
9 weeks
Interval 1.0 to 12.0
|
11 weeks
Interval 1.0 to 12.0
|
Adverse Events
Oasis
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oasis
n=41 participants at risk
Oasis
Oasis Ultra applied once per week for up to 12 weeks.
|
Standard
n=41 participants at risk
Standard Care
Standard Care as chosen by the Investigator
|
|---|---|---|
|
Gastrointestinal disorders
GERD
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
|
Renal and urinary disorders
Renal Failure
|
4.9%
2/41 • Number of events 2 • Adverse event data was collected during the 12-week treatment period.
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.9%
2/41 • Number of events 2 • Adverse event data was collected during the 12-week treatment period.
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
|
Infections and infestations
Osteomyelitis
|
4.9%
2/41 • Number of events 2 • Adverse event data was collected during the 12-week treatment period.
|
12.2%
5/41 • Number of events 5 • Adverse event data was collected during the 12-week treatment period.
|
|
Infections and infestations
Gangrene
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
|
Infections and infestations
Infection
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
4.9%
2/41 • Number of events 2 • Adverse event data was collected during the 12-week treatment period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
|
Gastrointestinal disorders
Lower GI hermorrhage
|
0.00%
0/41 • Adverse event data was collected during the 12-week treatment period.
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected during the 12-week treatment period.
|
Other adverse events
Adverse event data not reported
Additional Information
Vice President, Medical & Clinical Affairs
Smith & Nephew, Inc.
Phone: 817-302-3914
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
- Publication restrictions are in place
Restriction type: OTHER