Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers

Status unconfirmed · Not applicable

Conditions studied: Venous Ulcer, Foot Ulcer, Diabetic

In brief

This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey

Key facts

Study ID

NCT02838784

Run by

Tides Medical

People needed

134

Starts

2016-09-01

Expected to finish

2018-12-01

Last updated by the study team

2017-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Southwest Austin Foot & Ankle Clinic, PLLC — Austin, Texas, United States (enrolling)
• Iberia Medical Center — New Iberia, Louisiana, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• Global Podiatry Partners, Inc — Arcadia, California, United States (enrolling)
• Livingston Podiatry Associates PLLC — Bellmore, New York, United States (enrolling)
• Foot & Ankle Physicians of Ohio — Grove City, Ohio, United States (enrolling)
• Foot & Ankle Center of Nebraska — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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