Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers (TMArtacent)
Venous Ulcer, Foot Ulcer, Diabetic
About this trial
This is an interventional treatment trial for Venous Ulcer
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Able and willing to give consent and to comply with study
- Lower extremity ulcer between 1 and 25 cm2 point after the 4 week run-in period
- Has received documented SOC treatment for 4 weeks or greater duration resulting in <50% reduction in the ulcer size
- No clinical signs of infection at the ulcer site
- Serum Creatinine below 3.0 mg/dl
- Serum HgA1c below 12%
- Adequate circulation to the affected limb with ABI between 0.7 and 1.2 or tri-/bi-phasic arterial waveforms at the ankle of the affected leg.
Exclusion Criteria:
- Is participating in another wound study
- Has a Charcot foot
- Has previously received a different biological graft on the target foot
- Has more than one lower extremity ulcer
- Has an ulcer that probes to bone or involves tendon, muscle, joint capsule or has sinus tracts
- Is currently receiving radiation or chemotherapy
- Has an autoimmune connective tissue disorder
- Is taking any medication known to be an immune system modulator
- Is pregnant or is considering becoming pregnant within the next 6 months
Sites / Locations
- Global Podiatry Partners, IncRecruiting
- Iberia Medical CenterRecruiting
- Ochsner Clinic FoundationRecruiting
- Foot & Ankle Center of Nebraska
- Livingston Podiatry Associates PLLCRecruiting
- Foot & Ankle Physicians of OhioRecruiting
- Southwest Austin Foot & Ankle Clinic, PLLCRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Artacent Human Amniotic Membrane
Lower Extremity Ulcer Standard of Care
Patients randomized to the Artacent group will receive standard of care (off-loading with a removable cast walker and non-adherent dressings in addition to debridement and use of moisture retentive dressing) and the application of the Artacent amniotic allograft once every two weeks for up to 5 applications or until the ulcer has healed.
Patients randomized to standard of care will receive off-loading with a removable cast walker and non-adherent dressings (e.g. Adaptic) in addition to debridement and use of moisture retentive dressings. An outer dressing will also be applied.