Trial Outcomes & Findings for Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers (NCT NCT01108263)

NCT ID: NCT01108263

Last Updated: 2014-03-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-03-17

Participant Flow

Participant milestones

Measure	Integra Flowable on Wound Bed INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.	INTEGRA Flowable on Wound & Injected Subcutaneously INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Integra Flowable on Wound Bed INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.	INTEGRA Flowable on Wound & Injected Subcutaneously INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
Overall Study Adverse Event	0	1

Baseline Characteristics

Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers

Baseline characteristics by cohort

Measure	Integra Flowable on Wound Bed n=2 Participants INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.	INTEGRA Flowable on Wound & Injected Subcutaneously n=3 Participants INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.	Total n=5 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	54.5 years STANDARD_DEVIATION 0.70711 • n=5 Participants	47 years STANDARD_DEVIATION 4.58258 • n=7 Participants	50 years STANDARD_DEVIATION 5.24404 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Integra Flowable on Wound Bed n=2 Participants INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.	INTEGRA Flowable on Wound & Injected Subcutaneously n=3 Participants INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
Overall Decrease in Wound Size	2 participants	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Integra Flowable on Wound Bed n=2 Participants INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.	INTEGRA Flowable on Wound & Injected Subcutaneously n=3 Participants INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.	2 participants	1 participants

Adverse Events

Integra Flowable on Wound Bed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

INTEGRA Flowable on Wound & Injected Subcutaneously

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Integra Flowable on Wound Bed n=2 participants at risk INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.	INTEGRA Flowable on Wound & Injected Subcutaneously n=3 participants at risk INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
Skin and subcutaneous tissue disorders Wound infection	0.00% 0/2	33.3% 1/3
Cardiac disorders Chest pain	0.00% 0/2	33.3% 1/3

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Steinberg, Principal Investigator

Georgetown University

Phone: 202-444-0793

Email: zr40@georgetown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER