Trial Outcomes & Findings for Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care (NCT NCT03626623)

NCT ID: NCT03626623

Last Updated: 2021-08-25

Results Overview

The primary endpoint of the study is to measure the incidence of complete wound closure (defined as 100% epithelialization) between randomized groups. Number of wounds was calculated as the total across all participants.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: up to 12 weeks
• Results posted on: 2021-08-25

Participant Flow

Participant milestones

Measure	Standard of Care (SOC) The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.	Cytal Wound Matrix 1-Layer The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU). Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.
Overall Study STARTED	5	10
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care

Baseline characteristics by cohort

Measure	Standard of Care (SOC) n=5 Participants The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.	Cytal Wound Matrix 1-Layer n=10 Participants The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU). Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.	Total n=15 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	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Number of Wounds	5 Wounds n=5 Participants	10 Wounds n=7 Participants	15 Wounds n=5 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: The study was terminated by sponsor prior to completion, all enrolled subjects did not complete 12 weeks follow-up prior to termination.

The primary endpoint of the study is to measure the incidence of complete wound closure (defined as 100% epithelialization) between randomized groups. Number of wounds was calculated as the total across all participants.

Outcome measures

Measure	Standard of Care (SOC) n=4 Participants The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.	Cytal Wound Matrix 1-Layer n=9 Participants The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU). Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.
Number of Wounds With Wound Closure	1 wounds	1 wounds

SECONDARY outcome

Timeframe: up to 12 weeks

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

Measure changes in wound size, measured in cm2/week between randomized groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 weeks

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

Measure time to complete wound closure between randomized groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 26 week visit and 52 week visit

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

Measure wound recurrence after healing is complete between randomized groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit, visit #7, visit #13, 26 wk. visit, and 52 wk.visit

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

The Short Form-20 is a 20-item questionnaire used to assess generic health outcomes from the participant's perspective. Scores are linearly measured from 0 (worst) to 100 (best) health functioning scores, respectively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit, 26 week visit, and 52 week visit

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

The diabetic foot ulcer scale- short form (DFS-SF) is a 29-item questionnaire designed to assess the impact of diabetic foot ulcers (DFUs) and their intervention on quality of life of participants diagnosed with diabetes. Scores measured from 0 (lower) to 100 (higher) quality of life, respectively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

The visual analogue scale (VAS) is a psychometric response scale for pain. It measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a vertical line on a 10 cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in cm with a higher score (100) indicating greater pain intensity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit, visit 7, visit 13, 26 wk visit, and 52 wk visit

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e. dependence) or one (i.e. independence). This will be completed with the aid of a trained study staff member.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

This outcome measures diabetic foot ulcer (DFU) related adverse event frequency including unexpected adverse device events (UADEs) or serious adverse experiences (SAEs) throughout the duration of the study as well as evaluate such adverse event frequencies between randomized groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

This outcome measures changes in number of diabetic foot ulcer (DFU) related narcotic prescriptions by study participant and between randomized groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

This outcome measures any changes in ambulatory status (i.e. bed, wheel chair, walk w/ assistance, or walk independent) by study participant and between randomized groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

This outcome measures differences in "return to work status" and/or "reported work status", activities of daily living, or disability status by study participant and between randomized groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

This outcome measures the incidence of diabetic foot ulcer (DFU) specific related medical care a study participant receives outside of the medical care provided by the investigator. Examples of ancillary care include, but are not limited to, emergency room (ER) visits, urgent care visits, outside medical procedures such as surgery, etc. The incidence of subjects requiring ancillary medical care will be tabulated and compared between randomized groups. This data will be collected via two questions (i.e. "Did participant receive any ancillary medical care?" and "If "yes", then specify where"). Responses are verified using source documentation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

This outcome measures direct costs of the products by total cost per subject stratified by healed vs. non healed DFU.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 52 week visit (until study completion)

Population: The study was terminated by sponsor due to low enrollment and data were not collected.

This outcome measures total indirect and incidental costs of diabetic foot ulcer products used per study participant by each visit.

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care (SOC)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Cytal Wound Matrix 1-Layer

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care (SOC) n=5 participants at risk The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.	Cytal Wound Matrix 1-Layer n=10 participants at risk The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU). Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.
Cardiac disorders chest pain	0.00% 0/5 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
Infections and infestations infection of target wound/ulcer	0.00% 0/5 • 30 weeks	20.0% 2/10 • Number of events 2 • 30 weeks
Infections and infestations cellulitis of target wound/ulcer	40.0% 2/5 • Number of events 2 • 30 weeks	0.00% 0/10 • 30 weeks
Infections and infestations elbow infection	20.0% 1/5 • Number of events 1 • 30 weeks	0.00% 0/10 • 30 weeks

Other adverse events

Measure	Standard of Care (SOC) n=5 participants at risk The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. Standard of Care (SOC): Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.	Cytal Wound Matrix 1-Layer n=10 participants at risk The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU). Cytal Wound Matrix 1-Layer: Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.
Eye disorders flash burn, eye	0.00% 0/5 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/5 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
General disorders common cold	0.00% 0/5 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
General disorders wound recurrence (after closure)	0.00% 0/5 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
General disorders new toe wound on target foot	20.0% 1/5 • Number of events 1 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
General disorders new wound on non-target limb	0.00% 0/5 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
Infections and infestations thumb infection	20.0% 1/5 • Number of events 1 • 30 weeks	0.00% 0/10 • 30 weeks
Infections and infestations cellulitis, leg	20.0% 1/5 • Number of events 1 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks
Infections and infestations infection of target wound	0.00% 0/5 • 30 weeks	10.0% 1/10 • Number of events 1 • 30 weeks

Additional Information

Allison Matthews

Integra LifeSciences

Phone: (443) 766-3869

Email: allison.matthews@integralife.com

Results disclosure agreements

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