Trial Outcomes & Findings for Santyl vs. Sharp Debridement of Diabetic Foot Wounds (NCT NCT01056198)

Results Overview

The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

baseline and 28 days

Results posted on

2012-11-21

Participant Flow

4/1/2010 to 8/2/2011 at 7 clinics in the U.S.

Participant milestones

Participant milestones
Measure	Santyl 2 mm Santyl once daily (QD)	Control Daily gauze and optional sharp debridement
Overall Study STARTED	24	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Santyl vs. Sharp Debridement of Diabetic Foot Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Santyl n=24 Participants 2 mm Santyl once daily (QD)	Control n=24 Participants Daily gauze and optional sharp debridement	Total n=48 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	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age Continuous	58.5 years STANDARD_DEVIATION 13.3 • n=5 Participants	63.5 years STANDARD_DEVIATION 9.8 • n=7 Participants	61.0 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 28 days

Population: Intent-to-Treat population

The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).

Outcome measures

Outcome measures
Measure	Santyl n=24 Participants 2 mm Santyl once daily (QD)	Control n=24 Participants Daily gauze and optional sharp debridement
Bates-Jensen Wound Assessment Score - Modified (BWAT-m)	15.8 units on a scale Standard Deviation 4.5	13.8 units on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: baseline and 28 days

Population: Intent-to-Treat population

Outcome measures

Outcome measures
Measure	Santyl n=24 Participants 2 mm Santyl once daily (QD)	Control n=24 Participants Daily gauze and optional sharp debridement
Percent of Wound Area Change From Baseline at End of Treatment	-44.9 percentage of baseline wound area Standard Error 17.0	0.8 percentage of baseline wound area Standard Error 57.2

SECONDARY outcome

Timeframe: baseline and 84 days

Population: Intent-to-Treat population

Outcome measures

Outcome measures
Measure	Santyl n=24 Participants 2 mm Santyl once daily (QD)	Control n=24 Participants Daily gauze and optional sharp debridement
Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up	-53.8 percentage of baseline wound area Standard Error 17.7	8.1 percentage of baseline wound area Standard Error 54.2

POST_HOC outcome

Timeframe: baseline and 28 days

Population: Intent-to-treat

Wound area at the end of treatment visit compared to the wound area at baseline for each subject

Outcome measures

Outcome measures
Measure	Santyl n=24 Participants 2 mm Santyl once daily (QD)	Control Daily gauze and optional sharp debridement
Change From Baseline in Wound Area - Santyl Treatment Group Baseline wound area	3.0 square centimeters Standard Deviation 2.1	—
Change From Baseline in Wound Area - Santyl Treatment Group Wound area at 28 days	1.8 square centimeters Standard Deviation 2.5	—

POST_HOC outcome

Timeframe: baseline and 28 days

Population: Intent-to-treat

Wound area at the end of treatment visit compared to the wound area at baseline for each subject

Outcome measures

Outcome measures
Measure	Santyl n=24 Participants 2 mm Santyl once daily (QD)	Control Daily gauze and optional sharp debridement
Change From Baseline in Wound Area - Control Group Baseline wound area	2.4 square centimeters Standard Deviation 2.1	—
Change From Baseline in Wound Area - Control Group Wound area at 28 days	2.3 square centimeters Standard Deviation 4.9	—

Adverse Events

Santyl

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Santyl n=24 participants at risk 2 mm Santyl once daily (QD)	Control n=24 participants at risk Daily gauze and optional sharp debridement
Infections and infestations Abscess limb	4.2% 1/24 • Number of events 1 • 84 weeks	0.00% 0/24 • 84 weeks
Cardiac disorders Bradycardia	0.00% 0/24 • 84 weeks	4.2% 1/24 • Number of events 1 • 84 weeks
Metabolism and nutrition disorders Fluid overload	0.00% 0/24 • 84 weeks	4.2% 1/24 • Number of events 1 • 84 weeks
Infections and infestations Gangrene	4.2% 1/24 • Number of events 1 • 84 weeks	0.00% 0/24 • 84 weeks
Vascular disorders Peripheral ischemia	0.00% 0/24 • 84 weeks	4.2% 1/24 • Number of events 1 • 84 weeks
Infections and infestations Wound infection	0.00% 0/24 • 84 weeks	4.2% 1/24 • Number of events 1 • 84 weeks

Other adverse events

Other adverse events
Measure	Santyl n=24 participants at risk 2 mm Santyl once daily (QD)	Control n=24 participants at risk Daily gauze and optional sharp debridement
Infections and infestations Cellulitis	0.00% 0/24 • 84 weeks	8.3% 2/24 • Number of events 2 • 84 weeks
Vascular disorders Hypertension	0.00% 0/24 • 84 weeks	8.3% 2/24 • Number of events 2 • 84 weeks
Musculoskeletal and connective tissue disorders Nervous system disorders	0.00% 0/24 • 84 weeks	12.5% 3/24 • Number of events 3 • 84 weeks
General disorders Oedema peripheral	8.3% 2/24 • Number of events 2 • 84 weeks	0.00% 0/24 • 84 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 2/24 • Number of events 2 • 84 weeks	0.00% 0/24 • 84 weeks
Infections and infestations Upper respiratory tract infection	8.3% 2/24 • Number of events 2 • 84 weeks	0.00% 0/24 • 84 weeks
Injury, poisoning and procedural complications Wound complications	0.00% 0/24 • 84 weeks	8.3% 2/24 • Number of events 2 • 84 weeks

Additional Information

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

Healthpoint Biotherapeutics

Phone: 817-302-3914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place