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

A Prospective, Randomized, Controlled Trial Comparing Cytal Wound Matrix 1-Layer to Standard of Care (SOC) in the Management of Diabetic Foot Ulcers (DFUs)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03626623

Enrollment

Registered

2018-08-13

Start date

2019-05-21

Completion date

2020-02-18

Last updated

2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Foot

Keywords

Diabetes, Foot Ulcer

Brief summary

This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.

Detailed description

This is a prospective, two-armed, multi-center randomized controlled trial (RCT) comparing Cytal Wound Matrix 1-Layer intervention to standard of care (SOC) intervention in patients presenting with diabetic foot ulcers (DFU). Up to one hundred and fifty patients recruited from US based medical centers and randomized (using a 2(active):1(control) randomization scheme) to receive either Cytal Wound Matrix 1-Layer intervention or standard of care intervention.Complete wound closure incidence, wound healing rates, wound recurrence, and various health related quality of life (HRQOL) outcomes will be compared between study arms. Additionally, a cost effective analysis (i.e. direct and indirect costs) and review of individual and group changes in narcotic prescription patterns will also be evaluated. While incidence of wound closure rates will be evaluated through 12 weeks, protocol defined patient follow-up is for two years. Data will be captured for remaining study objectives during these two years. An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee (CEC) will adjudicate all adverse events (AEs) and serious adverse events (SAEs).

Interventions

DEVICECytal 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.

OTHERStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form by subject or legally authorized representative. 2. 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. 3. Subject is male or female and at least 21years of age. 4. Subject has a clinical diagnosis of type 1 or type 2 diabetes. 5. Subject's current foot ulcer(s) has been present for \> 30 days and ≤ 365 days. 6. Subject's current foot ulcer(s), post-debridement is/are predominantly below the malleoli and on the plantar surface of the foot. 7. Subject's foot ulcer(s) must be Wagner type 1 or type 2. 8. Post debridement, subject's ulcer(s) are free of necrotic debris and appear to be comprised of healthy, vascularized tissue. 9. All qualifying ulcers are ≥ 5cm away from any other ulcer on the same foot. 10. Subject's ulcer(s) is ≥ 1cm2 and ≤ 20cm2 at randomization (length x width). 11. Subject's HbA1C reading is ≤10%. 12. Subject's Serum Creatinine ≤ 3.0mg/dL. 13. Subject has adequate circulation to the foot as measured by Ankle-Brachial Index (ABI) ≥ 0.7. 14. 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: 1. Subject is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable. 2. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference. 3. Subject report of concurrent participation in another clinical trial that involves a drug. 4. 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. 5. Subject has clinical evidence of gangrene on any part of the affected foot. 6. 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. 7. Subject has unstable Charcot foot, Charcot foot with a bony prominence(s) or Charcot amputation. 8. Qualifying wound(s) is connected to another ulcer via a fistula. 9. 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. 10. Subject has or has had a malignant disease (other than basal cell carcinoma) that has not been in remission for at least five years. 11. Subject is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such during the course of the study. 12. Subject has acute osteomyelitis of the affected foot. 13. Subject's ulcer(s) is accompanied by active cellulitis. 14. Subject has received growth factor or enzymatic therapy within 2 weeks of consent. 15. Subject is currently receiving or has received radiation, radiologic implants, or chemotherapy. 16. Subject is allergic to any of the primary or secondary dressing materials, including occlusive dressings and the adhesives on such dressings. 17. Subject's ulcer(s) has decreased in size by \>30% during the run-in phase. 18. Subject's ulcer(s) has increased in size by \>50% during the run-in phase. 19. Subject's ulcer(s) has tunnels or sinus tracts that cannot be completely debrided. 20. Subject has severe malnutrition as evidenced by albumin \<2.0 g/dL. 21. Subject has a bleeding disorder as documented by a diagnosis of a bleeding disorder. 22. Subject is on dialysis. 23. Any DFU(s) is infected and has not been treated for any clinically suspected infection prior to application of any product.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Complete Wound Closure Time	up to 12 weeks	Measure time to complete wound closure between randomized groups.
Wound Recurrence	at 26 week visit and 52 week visit	Measure wound recurrence after healing is complete between randomized groups.
Short Form-20 (SF-20)	Baseline visit, visit #7, visit #13, 26 wk. visit, and 52 wk.visit	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.
Diabetic Foot Ulcer Scale- Short Form (DFS-SF)	Baseline visit, 26 week visit, and 52 week visit	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.
Visual Analogue Scale (VAS) for Pain	Up to 52 week visit (until study completion)	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.
Katz Index of Independence in Activities of Daily Living (KATZ ADL)	Baseline visit, visit 7, visit 13, 26 wk visit, and 52 wk visit	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.
Wound Size Change	up to 12 weeks	Measure changes in wound size, measured in cm2/week between randomized groups.
Narcotic Prescription Changes Between Trial Arms	up to 52 week visit (until study completion)	This outcome measures changes in number of diabetic foot ulcer (DFU) related narcotic prescriptions by study participant and between randomized groups.
Participant Ambulatory Status	up to 52 week visit (until study completion)	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.
Return to Work Status	up to 52 week visit (until study completion)	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.
Diabetic Foot Ulcer (DFU) Specific Ancillary Medical Care	up to 52 week visit (until study completion)	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.
Diabetic Foot Ulcer (DFU) Related Direct Product(s) Costs	up to 52 week visit (until study completion)	This outcome measures direct costs of the products by total cost per subject stratified by healed vs. non healed DFU.
Indirect Diabetic Foot Ulcer (DFU) Product(s) Costs	up to 52 week visit (until study completion)	This outcome measures total indirect and incidental costs of diabetic foot ulcer products used per study participant by each visit.
Adverse Events Frequency	up to 52 week visit (until study completion)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	5
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.	10
Total	15

Baseline characteristics

Characteristic	Standard of Care (SOC)	Cytal Wound Matrix 1-Layer	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	1 Participants
Age, Categorical Between 18 and 65 years	5 Participants	9 Participants	14 Participants
Number of Wounds	5 Wounds	10 Wounds	15 Wounds
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	5 Participants	10 Participants	15 Participants
Sex: Female, Male Female	0 Participants	1 Participants	1 Participants
Sex: Female, Male Male	5 Participants	9 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 5	0 / 10
other Total, other adverse events	3 / 5	5 / 10
serious Total, serious adverse events	2 / 5	3 / 10

Outcome results

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
Standard of Care (SOC)	Number of Wounds With Wound Closure	1 wounds
Cytal Wound Matrix 1-Layer	Number of Wounds With Wound Closure	1 wounds

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.

Time frame: up to 52 week visit (until study completion)