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

NCT03626623 | Terminated Results FDA Device

• 1 other identifier: CR2017-006
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Diabetes; Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Wound Size Change

  up to 12 weeks

• Complete Wound Closure Time

  up to 12 weeks

• Wound Recurrence

  at 26 week visit and 52 week visit

• Short Form-20 (SF-20)

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

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

  Baseline visit, 26 week visit, and 52 week visit

Study Arms (2)

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

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.

Cytal Wound Matrix 1-Layer

Standard of Care (SOC) OTHER

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.

Standard of Care (SOC)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (3)

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

Location

Louisiana State University Health Science Center (LSUHSC)

New Orleans, Louisiana, 70112, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Related Publications (7)

• 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.

  PMID: 15057876 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.

  PMID: 23846869 BACKGROUND

• Wu L, Norman G, Dumville JC, O'Meara S, Bell-Syer SE. Dressings for treating foot ulcers in people with diabetes: an overview of systematic reviews. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD010471. doi: 10.1002/14651858.CD010471.pub2.

  PMID: 26171906 BACKGROUND

• Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.

  PMID: 14986739 BACKGROUND

• Yazdanpanah L, Nasiri M, Adarvishi S. Literature review on the management of diabetic foot ulcer. World J Diabetes. 2015 Feb 15;6(1):37-53. doi: 10.4239/wjd.v6.i1.37.

  PMID: 25685277 BACKGROUND

• Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1.

  PMID: 24186882 BACKGROUND

• Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999 May;22(5):692-5. doi: 10.2337/diacare.22.5.692.

  PMID: 10332667 BACKGROUND

Related Links

• Description of Cytal Wound Matrix Products (including Cytal Wound Matrix 1-Layer)

MeSH Terms

Conditions

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

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Autoimmune Diseases; Immune System Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Due to early termination, additional primary and secondary endpoint analyses were not performed.

Results Point of Contact

• Title: Allison Matthews
• Organization: Integra LifeSciences

allison.matthews@integralife.com

(443) 766-3869

Study Officials

• Allison Matthews

  Integra LifeSciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: August 13, 2018
• Study Start: May 21, 2019
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: August 25, 2021
• Results First Posted: February 15, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)