PriMatrix for the Management of Diabetic Foot Ulcers



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:January 2017
End Date:June 2020
Contact:Andrew Tummon
Email:andrew.tummon@integralife.com
Phone:1-609-936-5490

Use our guide to learn which trials are right for you!

Prospective, Multi-center, Randomized, Controlled Trial Evaluating the Use of PriMatrix Dermal Repair Scaffold for the Management of Diabetic Foot Ulcers

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.

A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of
individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely
challenging as these ulcers may not respond to standard of care (SC) treatment and frequently
become infected.

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.

Inclusion Criteria:

1. A signed and dated informed consent form has been obtained from the subject.

2. Subject is able and willing to comply with study procedures.

3. Subject is male or female and is ≥ 18 years of age.

4. Subject, if female of child-bearing potential, must not be pregnant. To document
pregnancy status, subject statement is acceptable.

5. 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. Subject has at least one diabetic foot ulcer that meets all of the following criteria:

1. Ulcer which has been in existence for a minimum of two weeks, prior to signing
Informed Consent for trial participation.

2. Ulcer has been diagnosed as either a partial or full thickness diabetic foot
ulcer without tunneling, undermining, sinus tracts, or capsule/tendon/bone
exposure,

3. Ulcer is either located on the foot or ankle (with no portion above the top of
the malleolus),

4. Ulcer size (area) is greater than or equal to 1 cm2 and less than or equal to 12
cm2 post-debridement,

5. There is a minimum 1 cm margin between the qualifying study ulcer and any other
ulcers on the specified foot, post-debridement. If the subject has more than one
ulcer that meets the entrance criteria, the ulcer designated as the study ulcer
will be at the discretion of the Investigator. Non study ulcers may be treated at
the Investigator's discretion however excluded treatments listed in Section
3.4.3.1 must not be used on non-study ulcers.

7. Subject has adequate vascular perfusion of the affected limb, as defined by at least
one of the following:

1. Ankle-Brachial Index (ABI) ≥ 0.65 or ≤1.2,

2. Toe pressure (plethysmography) > 50 mmHg,

3. TcPO2 > 40 mmHg

8. Subject or responsible caregiver is willing and able to maintain required applicable
dressing changes as well as off-loading for the location of the ulcer.

Exclusion Criteria:

1. Subject was previously randomized and treated under this clinical study protocol.

2. Subject has suspected or confirmed signs/symptoms of gangrene or wound infection as
evidenced by redness, pain, and purulent drainage on any part of the affected limb.

3. Subject has suspected or confirmed osteomyelitis of the foot.

4. Subject has a history of hypersensitivity to bovine collagen, as determined by prior
medical history.

5. Subject has participated in another clinical trial involving a device or a
systemically administered investigational study drug/treatment within 30 days of
randomization.

6. Subject has received within 30 days of signing Informed Consent Form or scheduled to
receive a medication or treatment which is known to interfere with or affect the rate
or quality of wound healing (e.g. systemic steroids, immunosuppressive therapy,
autoimmune disease therapy, dialysis, radiation therapy to the foot, vascular surgery,
angioplasty, or thrombolysis).

7. Subject has a history of bone cancer or metastatic disease on the affected limb,
radiation therapy to the foot, or has had chemotherapy within 12 months prior to
signing Informed Consent Form for trial participation.

8. Subject has a condition that would interfere with their ability to comply with the
treatment regimen (ability to perform required dressing changes and off-loading as
well as ability to comply with treatment visit schedule).

9. In the opinion of the Investigator the subject has a history of or is currently
diagnosed with any illnesses or conditions, other than diabetes, that could interfere
with wound healing (e.g. end-stage renal disease, severe malnutrition, liver disease,
aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV
positive, or exacerbation of sickle cell anemia).

10. In the opinion of the Investigator the subject has unstable Charcot foot or Charcot
with bony prominence that could inhibit wound healing.

11. Subject has ulcers secondary to a disease other than diabetes (e.g. vasculitis,
neoplasms, or hematological disorders).

12. In the opinion of the Investigator the subject has excessive lymphedema that could
interfere with off-loading and/or wound healing.

13. Subject with a non-healed surgical site from a prior amputation that has been open for
less than 30 days.

14. Subject has been treated with wound dressings that include growth factors, engineered
tissues, or skin substitutes within 30 days of randomization or is scheduled to
receive treatment during the study. (e.g. Regranex, Dermagraft, Apligraf, EpiFix,
GraftJacket, OASIS, Omnigraft, or Integra BMWD).

15. Subject has been treated with hyperbaric oxygen or topical oxygen therapy within 5
days of the Screening Visit or is scheduled to receive hyperbaric oxygen treatment or
topical oxygen therapy during the study.

16. Subject has been treated with negative pressure wound therapy within 72 hours of the
Screening Visit or is scheduled to receive negative pressure wound therapy during the
study.

17. At the end of the Screening Phase the area of the study ulcer (after sharp
debridement) has decreased by more than 30% over the two week screening period.
We found this trial at
19
sites
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Castro Valley, California 94546
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Durango, Colorado 81301
?
mi
from
Durango, CO
Click here to add this to my saved trials
Fresno, California 93721
?
mi
from
Fresno, CA
Click here to add this to my saved trials
3875 Wilshire Boulevard
Los Angeles, California 90057
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
McAllen, Texas 78501
?
mi
from
McAllen, TX
Click here to add this to my saved trials
5801 Fashion Boulevard
Murray, Utah 84107
?
mi
from
Murray, UT
Click here to add this to my saved trials
555 8th Avenue
New York, New York 10022
?
mi
from
New York, NY
Click here to add this to my saved trials
16800 Northwest 2nd Avenue
North Miami, Florida 33169
?
mi
from
North Miami, FL
Click here to add this to my saved trials
754 South Main Street
Saint George, Utah 84770
?
mi
from
Saint George, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
1010 Nut Tree Road
Vacaville, California 95687
?
mi
from
Vacaville, CA
Click here to add this to my saved trials
3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
?
mi
from
Washington,
Click here to add this to my saved trials
2229 North Commerce Parkway
Weston, Florida 33326
?
mi
from
Weston, FL
Click here to add this to my saved trials
York, Pennsylvania 17403
?
mi
from
York, PA
Click here to add this to my saved trials