Trial Outcomes & Findings for A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers (NCT NCT01143714)

NCT ID: NCT01143714

Last Updated: 2013-05-06

Results Overview

The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 57 participants
• Primary outcome timeframe: 4 Weeks
• Results posted on: 2013-05-06

Participant Flow

Adults aged 18 years and older, with a diabetic foot ulcer that has not responded to treatment

Participant milestones

Measure	Collagenase Santyl Ointment Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Vehicle (White Petrolatum) White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Overall Study STARTED	29	28
Overall Study COMPLETED	22	25
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Measure	Collagenase Santyl Ointment Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Vehicle (White Petrolatum) White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Overall Study Adverse Event	4	2
Overall Study Withdrawal by Subject	1	0
Overall Study Subject non-compliance	0	1
Overall Study wound closed = deemed healed	1	0
Overall Study wound size increased	1	0

Baseline Characteristics

A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers

Baseline characteristics by cohort

Measure	Collagenase Santyl Ointment n=29 Participants Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Vehicle (White Petrolatum) n=28 Participants White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Total n=57 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	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age Continuous	60.0 years STANDARD_DEVIATION 9.4 • n=5 Participants	59.9 years STANDARD_DEVIATION 12.4 • n=7 Participants	59.9 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: Sample size originally set at 100 to provide 80% power, a=0.05. Interim analysis when enrollment reached 50 indicated results would not change with additional enrollment. Intent-to-treat used for primary inference; Missing values imputed by method of population mean and last observation carried forward (wound area).

The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period

Outcome measures

Measure	Collagenase Santyl Ointment n=29 Participants Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Vehicle (White Petrolatum) n=28 Participants White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Change in Wound Area Treatment Phase	-32.74 percentage of average change in wound Standard Error 7.12	-33.08 percentage of average change in wound Standard Error 7.13
Change in Wound Area Follow-up Period	-49.34 percentage of average change in wound Standard Error 12.34	-34.27 percentage of average change in wound Standard Error 12.36

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat population

Outcome measures

Measure	Collagenase Santyl Ointment n=29 Participants Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Vehicle (White Petrolatum) n=28 Participants White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)	1.38 debridements Standard Error 0.22	1.5 debridements Standard Error 0.22

Adverse Events

Collagenase Santyl Ointment

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Vehicle (White Petrolatum)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Collagenase Santyl Ointment n=29 participants at risk Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Vehicle (White Petrolatum) n=28 participants at risk White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Cardiac disorders Cardiac Failure	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	0.00% 0/28 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Infections and infestations Necrotizing Fasciitis	0.00% 0/29 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	3.6% 1/28 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Infections and infestations Osteomyelitis	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	3.6% 1/28 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Infections and infestations Sepsis	0.00% 0/29 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	3.6% 1/28 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Infections and infestations Staphylococcal bacteraemia	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	0.00% 0/28 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Injury, poisoning and procedural complications Fall	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	0.00% 0/28 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/29 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	3.6% 1/28 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Metabolism and nutrition disorders Diabetic ketoacidosis	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	0.00% 0/28 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	0.00% 0/28 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Metabolism and nutrition disorders Hypoglycaemia	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	0.00% 0/28 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/29 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	3.6% 1/28 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Renal and urinary disorders Renal Failure Acute	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	0.00% 0/28 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Renal and urinary disorders Renal Injury	0.00% 0/29 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	3.6% 1/28 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.

Other adverse events

Measure	Collagenase Santyl Ointment n=29 participants at risk Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.	Vehicle (White Petrolatum) n=28 participants at risk White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Infections and infestations Cellulitis	0.00% 0/29 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	7.1% 2/28 • Number of events 2 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.
Skin and subcutaneous tissue disorders Diabetic Ulcer	3.4% 1/29 • Number of events 1 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.	10.7% 3/28 • Number of events 3 • 12 weeks Covered both 4 week treatment phase and the 8 week follow-up period.

Additional Information

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

Healthpoint, Ltd.

Phone: 817-302-3914

Email: jaime.dickerson@healthpoint.com

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