Trial Outcomes & Findings for Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers (NCT NCT01143727)

Results Overview

Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

28 days

Results posted on

2013-05-31

Participant Flow

Adults aged 18 years and older, with Type I or II diabetes mellitus and at least one inflamed diabetic foot ulcer

Participant milestones

Participant milestones
Measure	Collagenase Santyl Ointment Santyl Santyl : Applied once every 24-hr period sufficient to cover the wound.	Control Tegaderm Hydrogel Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound.
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Collagenase Santyl Ointment n=9 Participants Santyl Santyl : Applied once every 24-hr period sufficient to cover the wound.	Control n=8 Participants Tegaderm Hydrogel Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Age Continuous	61.4 years STANDARD_DEVIATION 15.3 • n=93 Participants	58.0 years STANDARD_DEVIATION 17.8 • n=4 Participants	59.8 years STANDARD_DEVIATION 16.1 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment United States	9 participants n=93 Participants	8 participants n=4 Participants	17 participants n=27 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 12 subjects initially for this exploratory study. 17 subjects enrolled to ensure 12 evaluable. Intent-to-treat used for primary inference. Missing values imputed by method of population mean (BWAT-m) and last observation carried forward (wound area).

Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.

Outcome measures

Outcome measures
Measure	Collagenase Santyl Ointment n=9 Participants Santyl Santyl : Applied once every 24-hr period sufficient to cover the wound.	Control n=8 Participants Tegaderm Hydrogel Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound.
Wound Appearance Baseline	19 units on a scale Standard Deviation 5.4	19 units on a scale Standard Deviation 1.8
Wound Appearance Week 4	16.9 units on a scale Standard Deviation 7.6	14.5 units on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 28 days

Population: Intent-to-Treat

Outcome measures

Outcome measures
Measure	Collagenase Santyl Ointment n=9 Participants Santyl Santyl : Applied once every 24-hr period sufficient to cover the wound.	Control n=8 Participants Tegaderm Hydrogel Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound.
Percent Change in Wound Area	-69.9 percentage change from baseline area Standard Deviation 39.0 • Interval -100.0 to 23.0	-41.6 percentage change from baseline area Standard Deviation 105.0 • Interval -100.0 to 213.0

Adverse Events

Collagenase Santyl Ointment

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Collagenase Santyl Ointment n=9 participants at risk Santyl Santyl : Applied once every 24-hr period sufficient to cover the wound.	Control n=8 participants at risk Tegaderm Hydrogel Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound.
Infections and infestations Pneumonia	11.1% 1/9 • Number of events 1	0.00% 0/8
Infections and infestations Cellulitis	0.00% 0/9	12.5% 1/8 • Number of events 1

Other adverse events

Other adverse events
Measure	Collagenase Santyl Ointment n=9 participants at risk Santyl Santyl : Applied once every 24-hr period sufficient to cover the wound.	Control n=8 participants at risk Tegaderm Hydrogel Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound.
Gastrointestinal disorders Oedema Peripheral	11.1% 1/9 • Number of events 1	12.5% 1/8 • Number of events 1
Skin and subcutaneous tissue disorders Diabetic Ulcer	11.1% 1/9 • Number of events 1	25.0% 2/8 • Number of events 2

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