Trial Outcomes & Findings for Wound Edge Changes Following Treatment With Santyl (NCT NCT01197898)

NCT ID: NCT01197898

Last Updated: 2013-05-30

Results Overview

The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

28 Days

Results posted on

2013-05-30

Participant Flow

Patients with Type I or II diabetes mellitus and a non-healing foot ulcer including postamputation wounds and wounds on the dorsum of the foot.

Participant milestones

Participant milestones
Measure	Collagenase Santyl Ointment Applied once daily Collagenase Santyl Ointment : Topical daily application	Vehicle Base Applied once daily Placebo Comparator : Topical daily application
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wound Edge Changes Following Treatment With Santyl

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Collagenase Santyl Ointment n=5 Participants Applied once daily Collagenase Santyl Ointment : Topical daily application	Vehicle Base n=5 Participants Applied once daily Placebo Comparator : Topical daily application	Total n=10 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	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	72.4 years STANDARD_DEVIATION 8.3 • n=5 Participants	50.6 years STANDARD_DEVIATION 10.2 • n=7 Participants	61.5 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: Goal was to complete 10 subjects in an allocation ratio of 1:1 for Santyl vs. placebo. Since this was an exploratory study, the sample size was arbitrary.

Outcome measures

Outcome measures
Measure	Collagenase Santyl Ointment n=3 Participants Applied once daily Collagenase Santyl Ointment : Topical daily application	Vehicle Base n=3 Participants Applied once daily Placebo Comparator : Topical daily application
Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.	NA participants The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis.	NA participants The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis.

Adverse Events

Collagenase Santyl Ointment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Base

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Collagenase Santyl Ointment n=5 participants at risk Applied once daily Collagenase Santyl Ointment : Topical daily application	Vehicle Base n=5 participants at risk Applied once daily Placebo Comparator : Topical daily application
Hepatobiliary disorders Acute Cholecystitis	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/5 • 28 days

Other adverse events

Adverse event data not reported

Additional Information

Jaime E. Dickerson, PhD; Sr. Director Clinical Affairs

Healthpoint, Ltd.

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