Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-... | NCT03626623

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care (SOC)	Placebo Comparator	The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds.	Other: Standard of Care (SOC)
Cytal Wound Matrix 1-Layer	Active Comparator	The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU).	Device: Cytal Wound Matrix 1-Layer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytal Wound Matrix 1-Layer	Device	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.

Measure	Description	Time Frame
Number of Wounds With Wound Closure	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.	up to 12 weeks

Measure	Description	Time Frame
Wound Size Change	Measure changes in wound size, measured in cm2/week between randomized groups.	up to 12 weeks
Complete Wound Closure Time	Measure time to complete wound closure between randomized groups.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Provision of signed and dated informed consent form by subject or legally authorized representative.
Stated willingness to comply with all study procedures and availability for the duration of the study. Subject is able and willing to tolerate non-removable offloading device for the duration of the run-in and intervention phases of the study.
Subject is male or female and at least 21years of age.
Subject has a clinical diagnosis of type 1 or type 2 diabetes.
Subject's current foot ulcer(s) has been present for > 30 days and ≤ 365 days.
Subject's current foot ulcer(s), post-debridement is/are predominantly below the malleoli and on the plantar surface of the foot.
Subject's foot ulcer(s) must be Wagner type 1 or type 2.
Post debridement, subject's ulcer(s) are free of necrotic debris and appear to be comprised of healthy, vascularized tissue.
All qualifying ulcers are ≥ 5cm away from any other ulcer on the same foot.
Subject's ulcer(s) is ≥ 1cm2 and ≤ 20cm2 at randomization (length x width).
Subject's HbA1C reading is ≤10%.
Subject's Serum Creatinine ≤ 3.0mg/dL.
Subject has adequate circulation to the foot as measured by Ankle-Brachial Index (ABI) ≥ 0.7.
Negative pregnancy test at randomization for women.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Subject is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
Subject report of concurrent participation in another clinical trial that involves a drug.
The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
Subject has clinical evidence of gangrene on any part of the affected foot.
The subject's ulcer(s) is/are due to a non-diabetic etiology, ulcers of arterial, venous stasis, pressure, radiation, traumatic, rheumatoid, vasculitis, collagen vascular disease, or other non-diabetic etiologies.
Subject has unstable Charcot foot, Charcot foot with a bony prominence(s) or Charcot amputation.
Qualifying wound(s) is connected to another ulcer via a fistula.
Subject has one or more medical condition(s) including: renal, hepatic, hematological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this wound healing study.
Subject has or has had a malignant disease (other than basal cell carcinoma) that has not been in remission for at least five years.
Subject is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such during the course of the study.
Subject has acute osteomyelitis of the affected foot.
Subject's ulcer(s) is accompanied by active cellulitis.
Subject has received growth factor or enzymatic therapy within 2 weeks of consent.
Subject is currently receiving or has received radiation, radiologic implants, or chemotherapy.
Subject is allergic to any of the primary or secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
Subject's ulcer(s) has decreased in size by >30% during the run-in phase.
Subject's ulcer(s) has increased in size by >50% during the run-in phase.
Subject's ulcer(s) has tunnels or sinus tracts that cannot be completely debrided.
Subject has severe malnutrition as evidenced by albumin <2.0 g/dL.
Subject has a bleeding disorder as documented by a diagnosis of a bleeding disorder.
Subject is on dialysis.
Any DFU(s) is infected and has not been treated for any clinically suspected infection prior to application of any product.

Name	Affiliation	Role
Allison Matthews	Integra LifeSciences	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Limb Preservation Platform, Inc.		Fresno	California	93710	United States
Louisiana State University Health Science Center (LSUHSC)

PubMed Identifier	Type	Citation	Retractions
15057876	Background	Chen YH, DeMets DL, Lan KK. Increasing the sample size when the unblinded interim result is promising. Stat Med. 2004 Apr 15;23(7):1023-38. doi: 10.1002/sim.1688.
23846869	Background	Dumville JC, O'Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013 Jul 12;2013(7):CD009101. doi: 10.1002/14651858.CD009101.pub3.

Label	URL
Description of Cytal Wound Matrix Products (including Cytal Wound Matrix 1-Layer)	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 27, 2019

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0005 BG00110 BG00215

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Wounds With Wound Closure

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.

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

Posted

Number

wounds

up to 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0004 OG0019

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0011

Secondary

Wound Size Change

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

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

Posted

up to 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Complete Wound Closure Time

Measure time to complete wound closure between randomized groups.

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

Posted

up to 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Wound Recurrence

Measure wound recurrence after healing is complete between randomized groups.

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

Posted

at 26 week visit and 52 week visit

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Short Form-20 (SF-20)

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.

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

Posted

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Diabetic Foot Ulcer Scale- Short Form (DFS-SF)

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.

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

Posted

Baseline visit, 26 week visit, and 52 week visit

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Visual Analogue Scale (VAS) for Pain

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.

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

Posted

Up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Katz Index of Independence in Activities of Daily Living (KATZ ADL)

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.

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

Posted

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Adverse Events Frequency

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.

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

Posted

up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Narcotic Prescription Changes Between Trial Arms

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

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

Posted

up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Participant Ambulatory Status

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.

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

Posted

up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Return to Work Status

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.

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

Posted

up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Diabetic Foot Ulcer (DFU) Specific Ancillary Medical Care

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.

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

Posted

up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Diabetic Foot Ulcer (DFU) Related Direct Product(s) Costs

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

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

Posted

up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Indirect Diabetic Foot Ulcer (DFU) Product(s) Costs

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

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

Posted

up to 52 week visit (until study completion)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	5	2	5	3	5
EG001	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.	0	10	3	10	5	10

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
flash burn, eye	Eye disorders	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected10 at risk
pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected10 at risk
common cold	General disorders	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected10 at risk
wound recurrence (after closure)	General disorders	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected10 at risk
new toe wound on target foot	General disorders	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected10 at risk
new wound on non-target limb	General disorders	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected10 at risk
thumb infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected10 at risk
cellulitis, leg	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected10 at risk
infection of target wound	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected10 at risk

ID	Term
D003920	Diabetes Mellitus
D017719	Diabetic Foot
D003924	Diabetes Mellitus, Type 2
D003922	Diabetes Mellitus, Type 1
D016523	Foot Ulcer

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D048909	Diabetes Complications
D003929	Diabetic Neuropathies
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D005534	Foot Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Term	Organ System	Assessment Type	Statistical Information
chest pain	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected10 at risk
infection of target wound/ulcer	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected10 at risk
cellulitis of target wound/ulcer	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected5 at risk EG0010 events0 affected10 at risk
elbow infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected10 at risk