PriMatrix for the Management of Diabetic Foot Ulcers
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: January 01, 2017
End Date: June 01, 2018
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.
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 18.104.22.168 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.
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.