Trial Outcomes & Findings for Using Santyl on Diabetic Foot Ulcers (NCT NCT01408277)
NCT ID: NCT01408277
Last Updated: 2014-07-24
Results Overview
Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
6 and 12 weeks
Results posted on
2014-07-24
Participant Flow
Participant milestones
| Measure |
Santyl
Collagenase (SANTYL®) Ointment
|
Control
Standard Care
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
Santyl
Collagenase (SANTYL®) Ointment
|
Control
Standard Care
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Using Santyl on Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Santyl
n=28 Participants
Collagenase (SANTYL®) Ointment
|
Control
n=27 Participants
Standard Care
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 weeksPopulation: Primary analysis was based on the Intent-to-treat dataset which consisted of all subjects randomized to treatment.
Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.
Outcome measures
| Measure |
Santyl®
n=28 Participants
Collagenase (Santyl®) Ointment
|
Control
n=27 Participants
Control = Standard Care
Standard Care is defined as the standard wound care protocol for chronic wounds used by each Investigator, in their clinic (e.g., wet-to-dry, compression, sharp debridement, etc.).
|
|---|---|---|
|
Mean Percent Change in Wound Area
% change at end of 6 weeks
|
-68 percentage of change in wound area
Standard Error 6.3
|
-36 percentage of change in wound area
Standard Error 20.4
|
|
Mean Percent Change in Wound Area
% change at end of 12 weeks
|
-61 percentage of change in wound area
Standard Error 9.6
|
-46 percentage of change in wound area
Standard Error 18.3
|
Adverse Events
Santyl
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Control
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Santyl
n=28 participants at risk
Collagense (Santyl®) Ointment
|
Control
n=27 participants at risk
Standard Care
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Cellulitis
|
3.6%
1/28 • Number of events 1 • 12 weeks
|
3.7%
1/27 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Gangrene
|
3.6%
1/28 • Number of events 1 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Infections and infestations
Osteomyelitis
|
3.6%
1/28 • Number of events 1 • 12 weeks
|
7.4%
2/27 • Number of events 2 • 12 weeks
|
Other adverse events
| Measure |
Santyl
n=28 participants at risk
Collagense (Santyl®) Ointment
|
Control
n=27 participants at risk
Standard Care
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
7.1%
2/28 • Number of events 2 • 12 weeks
|
7.4%
2/27 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Osteomyelitis
|
3.6%
1/28 • Number of events 1 • 12 weeks
|
7.4%
2/27 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • 12 weeks
|
7.4%
2/27 • Number of events 2 • 12 weeks
|
|
Injury, poisoning and procedural complications
Wound complication
|
7.1%
2/28 • Number of events 2 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
7.1%
2/28 • Number of events 2 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
Additional Information
Jaime E Dickerson, Jr, PhD
Smith & Nephew Biotherapeutics
Phone: 817-302-3914
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place