PriMatrix for the Management of Diabetic Foot Ulcers

NCT03010319 | Completed Results

• 1 other identifier: T-PMXDFU-001
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 17

Brief Summary

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase

  Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.

  12-week Treatment Phase

Secondary Outcomes (4)

• Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase

  12-week treatment phase

• Time to Complete Wound Closure, as Assessed by the Investigator

  12-week Treatment Phase

• Time to Complete Wound Closure, as Assessed by Computerized Planimetry.

  12-week Treatment Phase

• Rate of Wound Closure, as Assessed by Computerized Planimetry.

  Weeks 1-12 during Treatment Phase

Study Arms (2)

PriMatrix

EXPERIMENTAL

Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.

Device: PriMatrix Dermal Repair Scaffold; Device: Secondary Dressings; Device: Offloading device

Standard of Care

ACTIVE COMPARATOR

Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.

Device: Secondary Dressings; Device: Offloading device

Interventions

PriMatrix Dermal Repair Scaffold DEVICE

Application of PriMatrix to ulcer

PriMatrix

Secondary Dressings DEVICE

Dressings to ensure moist wound environment

PriMatrix; Standard of Care

Offloading device DEVICE

Offloading device to decrease pressure to wound area

PriMatrix; Standard of Care

Eligibility Criteria

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

You may qualify if:

• Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization:
• The subject has signed and dated an informed consent form.
• In the opinion of the investigator, subject is able and willing to comply with study procedures, including study visits, study dressing regimens and compliance with study required off-loading device.
• The subject is ≥ 18 years of age.
• The subject, if female of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable.
• The subject has Type I or Type II diabetes mellitus with investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12% within 3 months prior to screening visit.
• The subject has at least one diabetic foot ulcer that meets ALL of the following criteria:
• Ulcer which has been in existence for a minimum of two weeks, prior to signing the Informed Consent Form for trial participation.
• Ulcer is a partial or full thickness diabetic foot ulcer without capsule/tendon/bone exposure.
• Ulcer does not have tunneling, undermining, or sinus tracts that necessitates surgical OR debridement and/or penetrates to capsule/tendon/bone.
• Ulcer is located on the foot or ankle (with no portion above the top of the malleolus).
• Ulcer size (area) is \> 1 cm2 and \< 12 cm2 post-debridement.
• There is a minimum 1 cm margin between the qualifying study ulcer and any other ulcer on that same foot, post-debridement.
• If the subject has more than one ulcer that meets the eligibility criteria, the ulcer designated as the study ulcer will be at the discretion of the investigator.
• The subject has adequate vascular perfusion of the affected limb as defined by at least one of the following:

You may not qualify if:

• Subjects will not be enrolled in the study if any of the following criteria are met:
• The subject was previously randomized and treated under this clinical study protocol.
• The subject has suspected or confirmed gangrene or ulcer infection of the study ulcer or receiving systemic antibiotics for the treatment of such.
• The subject has suspected or confirmed osteomyelitis of the foot with the study ulcer.
• The subject has a history of hypersensitivity to bovine collagen, as determined by prior medical history.
• Protocol Number: T-PMXDFU-01 Confidential Page 23 of 64 Version 5.0 06 Nov 2018
• The subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 28 days of randomization.
• The subject has received, within 28 of signing Informed Consent Form, or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of ulcer healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to the foot, vascular surgery, angioplasty, or thrombolysis).
• The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy within the 12 months prior to signing Informed Consent Form for trial participation.
• In the opinion of the investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease, aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia).
• In the opinion of the investigator, the subject has unstable Charcot foot or Charcot with bony prominence that could inhibit ulcer healing.
• The subject has ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders).
• In the opinion of the investigator, the subject has excessive lymphedema that could interfere with off-loading and/or ulcer healing.
• The study ulcer has received ulcer dressings that included growth factors, engineered tissues, or skin substitutes within 28 days of randomization or is scheduled to receive treatment during the study (e.g., Regranex, Dermagraft, Apligraf, EpiFix, GraftJacket, OASIS, Omnigraft, or Integra BMWD).
• At the end of the screening phase and based on planimetric assessment, the area of the study ulcer after sharp debridement has decreased by more than 30% over the two-week screening period.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (17)

ILD Research Center

Carlsbad, California, 92009, United States

Location

LA Foot & Ankle Clinic

Los Angeles, California, 90057, United States

Location

Center for Clinical Research, Inc.

San Francisco, California, 94115, United States

Location

Central Valley Vein and Wound

Selma, California, 93662, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Barry University Clinical Research

North Miami, Florida, 33169, United States

Location

LA Podiatry Group

West Palm Beach, Florida, 33406, United States

Location

Podiatry 1st

Belleville, Illinois, 62226, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Wound Care of Tulsa

Tulsa, Oklahoma, 74146, United States

Location

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

Location

Podiatric Medical Partners of Texas, P.A.

Dallas, Texas, 75208, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

Element Research Group

San Antonio, Texas, 78229, United States

Location

Foot and Ankle Institute

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Andrew Tummon Director, Global Clinical Affairs
• Organization: Integra LifeSciences

andrew.tummon@integralife.com

609-936-5490

Study Officials

• John Lantis, MD

  The Mount Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: January 3, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 29, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)