Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers
TMArtacent
The Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study
1 other identifier
interventional
134
1 country
7
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 13, 2017
October 1, 2017
2.2 years
July 15, 2016
October 11, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Wound closure
100% re-epithelialization of the wound without drainage or need for use of a dressing
12 weeks
Time to wound closure
\# of days to 50% or greater closure
12 weeks
Ulcer recurrence
Telephone survey to capture number of ulcer recurrences and treatment
6 months
Secondary Outcomes (5)
Quality of Life
12 weeks
Impact of Treatment on Return to Work
12 weeks
Time to full weight bearing status
12 weeks
Adverse Events and Secondary Treatments
12 weeks
Number of grafts and graft size(s)
12 weeks
Other Outcomes (1)
Health economic outcomes
12 weeks
Study Arms (2)
Artacent Human Amniotic Membrane
EXPERIMENTALPatients 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.
Lower Extremity Ulcer Standard of Care
ACTIVE COMPARATORPatients 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.
Interventions
Double layer dehydrated amnion product
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tides Medicallead
Study Sites (7)
Global Podiatry Partners, Inc
Arcadia, California, 91007, United States
Iberia Medical Center
New Iberia, Louisiana, 70560, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Foot & Ankle Center of Nebraska
Omaha, Nebraska, 68114, United States
Livingston Podiatry Associates PLLC
Bellmore, New York, 11710, United States
Foot & Ankle Physicians of Ohio
Grove City, Ohio, 43123, United States
Southwest Austin Foot & Ankle Clinic, PLLC
Austin, Texas, 78735, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2016
First Posted
July 20, 2016
Study Start
September 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 13, 2017
Record last verified: 2017-10