Clinical trial NCT02838784: Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers
Official title: The Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Ulcer
Foot Ulcer, Diabetic
Lead sponsor: Tides Medical
Sponsor class: INDUSTRY
First posted: 2016-07-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study is to document the efficacy of Artacent™ Human Amniotic Membrane (Artacent) in the treatment of diabetic and vascular lower extremity ulcers. The study will add to the currently available literature by also assessing the impact of treatment on quality of life and on heal economic outcomes. Finally the study will follow patients for longer than previous studies and will obtain data on healing and recurrence at 6 months.

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.

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

Primary outcomes:
measure: Wound closure
timeFrame: 12 weeks
measure: Time to wound closure
timeFrame: 12 weeks
measure: Ulcer recurrence
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 weeks
measure: Impact of Treatment on Return to Work
timeFrame: 12 weeks
measure: Time to full weight bearing status
timeFrame: 12 weeks
measure: Adverse Events and Secondary Treatments
timeFrame: 12 weeks
measure: Number of grafts and graft size(s)
timeFrame: 12 weeks
Other outcomes:
measure: Health economic outcomes
timeFrame: 12 weeks
Locations:
city: Arcadia
country: United States
facility: Global Podiatry Partners, Inc
state: California
city: New Iberia
country: United States
facility: Iberia Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Omaha
country: United States
facility: Foot & Ankle Center of Nebraska
state: Nebraska
city: Bellmore
country: United States
facility: Livingston Podiatry Associates PLLC
state: New York
city: Grove City
country: United States
facility: Foot & Ankle Physicians of Ohio
state: Ohio
city: Austin
country: United States
facility: Southwest Austin Foot & Ankle Clinic, PLLC
state: Texas
Study officials:
References: