Study Results
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View full resultsBasic Information
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COMPLETED
NA
226 participants
INTERVENTIONAL
2017-01-31
2020-08-31
Brief Summary
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Detailed Description
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Advanced wound therapies like PriMatrix have become an important strategy in the treatment of hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PriMatrix
Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.
PriMatrix Dermal Repair Scaffold
Application of PriMatrix to ulcer
Secondary Dressings
Dressings to ensure moist wound environment
Offloading device
Offloading device to decrease pressure to wound area
Standard of Care
Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.
Secondary Dressings
Dressings to ensure moist wound environment
Offloading device
Offloading device to decrease pressure to wound area
Interventions
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PriMatrix Dermal Repair Scaffold
Application of PriMatrix to ulcer
Secondary Dressings
Dressings to ensure moist wound environment
Offloading device
Offloading device to decrease pressure to wound area
Eligibility Criteria
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Inclusion Criteria
1. The subject has signed and dated an informed consent form.
2. 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.
3. The subject is ≥ 18 years of age.
4. The subject, if female of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable.
5. 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.
6. 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.
7. 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.
8. The subject has adequate vascular perfusion of the affected limb as defined by at least one of the following:
* Ankle-Brachial Index (ABI) ≥ 0.65 or ≤1.2, performed within 3 months of screening,
* Toe pressure (plethysmography) \> 50 mmHg at time of screening,
* TcPO2 \> 40 mmHg at time of screening
9. The subject or responsible caregiver is willing and able to maintain required applicable dressing changes as well as study required off-loading/protective device for the duration of the study.
Exclusion Criteria
1. The subject was previously randomized and treated under this clinical study protocol.
2. The subject has suspected or confirmed gangrene or ulcer infection of the study ulcer or receiving systemic antibiotics for the treatment of such.
3. The subject has suspected or confirmed osteomyelitis of the foot with the study ulcer.
4. 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
5. The subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 28 days of randomization.
6. 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).
7. 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.
8. 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).
9. In the opinion of the investigator, the subject has unstable Charcot foot or Charcot with bony prominence that could inhibit ulcer healing.
10. The subject has ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders).
11. In the opinion of the investigator, the subject has excessive lymphedema that could interfere with off-loading and/or ulcer healing.
12. 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).
13. 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.
18 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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John Lantis, MD
Role: PRINCIPAL_INVESTIGATOR
The Mount Sinai Medical Center
Locations
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ILD Research Center
Carlsbad, California, United States
LA Foot & Ankle Clinic
Los Angeles, California, United States
Center for Clinical Research, Inc.
San Francisco, California, United States
Central Valley Vein and Wound
Selma, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Barry University Clinical Research
North Miami, Florida, United States
LA Podiatry Group
West Palm Beach, Florida, United States
Podiatry 1st
Belleville, Illinois, United States
The Mount Sinai Medical Center
New York, New York, United States
Wound Care of Tulsa
Tulsa, Oklahoma, United States
Martin Foot and Ankle
York, Pennsylvania, United States
Podiatric Medical Partners of Texas, P.A.
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
JPS Health Network
Fort Worth, Texas, United States
Futuro Clinical Trials
McAllen, Texas, United States
Element Research Group
San Antonio, Texas, United States
Foot and Ankle Institute
St. George, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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T-PMXDFU-001
Identifier Type: -
Identifier Source: org_study_id
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