Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers
NCT ID: NCT02838784
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
134 participants
INTERVENTIONAL
2016-09-30
2018-12-31
Brief Summary
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Detailed Description
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The objectives of this study are 1) to compare Artacent to standard of care (SOC) in the treatment of non-healing lower extremity ulcers and 2) to evaluate the impact of treatment on patient quality of life. Health economic outcomes will also be collected. The proportion of patients receiving Artacent who have wound closure with 12 weeks will be compared to those patients receiving SOC only will be compared. A comparison of time to wound closure will also be compared between the two populations.
Patients who are randomized to the SOC group (control) and require further treatment at 12 weeks due to incomplete wound healing, may receive treatment with Artacent if the investigator determines that to be a potentially beneficial option.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Artacent Human Amniotic Membrane
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.
Artacent Human Amniotic Membrane
Double layer dehydrated amnion product
Lower Extremity Ulcer Standard of Care
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.
Standard of Care
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
Interventions
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Artacent Human Amniotic Membrane
Double layer dehydrated amnion product
Standard of Care
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Tides Medical
INDUSTRY
Responsible Party
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Locations
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Global Podiatry Partners, Inc
Arcadia, California, United States
Iberia Medical Center
New Iberia, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Foot & Ankle Center of Nebraska
Omaha, Nebraska, United States
Livingston Podiatry Associates PLLC
Bellmore, New York, United States
Foot & Ankle Physicians of Ohio
Grove City, Ohio, United States
Southwest Austin Foot & Ankle Clinic, PLLC
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Wenjay Sung, DPM
Role: primary
Amy Keyzer
Role: backup
Michelle Menard, DPM
Role: primary
Brandi Angelle
Role: backup
Noah Oliver, DPM
Role: primary
Terri Lopez
Role: backup
Michael Livingston, DPM
Role: primary
Donna Knepple
Role: backup
Elizabeth Hewitt, DPM
Role: primary
Tracy Perez
Role: backup
Mark Whitesides, DPM
Role: primary
Cindy Whitesides
Role: backup
Other Identifiers
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16-001
Identifier Type: -
Identifier Source: org_study_id