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

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

Study Overview

• Status: Unknown
• Conditions: Foot Ulcer, Diabetic; Venous Ulcer
• Intervention / Treatment: Other: Artacent Human Amniotic Membrane; Procedure: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Arcadia, California, United States, 91007
      • Recruiting
      • Global Podiatry Partners, Inc
      • Contact: Wenjay Sung, DPM; Phone Number: 626-275-2195
      • Contact: Amy Keyzer; Phone Number: 626-275-2195
  • Louisiana
    • New Iberia, Louisiana, United States, 70560
      • Recruiting
      • Iberia Medical Center
      • Contact: Michelle Menard, DPM; Phone Number: 337-367-0271
      • Contact: Brandi Angelle; Phone Number: 337-367-0271
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Clinic Foundation
      • Contact: Noah Oliver, DPM; Phone Number: 504-842-8751
      • Contact: Terri Lopez; Phone Number: 504-842-8751
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Completed
      • Foot & Ankle Center of Nebraska
  • New York
    • Bellmore, New York, United States, 11710
      • Recruiting
      • Livingston Podiatry Associates PLLC
      • Contact: Michael Livingston, DPM; Phone Number: 516-308-4500
      • Contact: Donna Knepple; Phone Number: 516-308-4500
  • Ohio
    • Grove City, Ohio, United States, 43123
      • Recruiting
      • Foot & Ankle Physicians of Ohio
      • Contact: Elizabeth Hewitt, DPM; Phone Number: 614-782-3668
      • Contact: Tracy Perez; Phone Number: 614-782-3668
  • Texas
    • Austin, Texas, United States, 78735
      • Recruiting
      • Southwest Austin Foot & Ankle Clinic, PLLC
      • Contact: Mark Whitesides, DPM; Phone Number: 512-447-4122
      • Contact: Cindy Whitesides; Phone Number: 512-447-4122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Artacent Human Amniotic Membrane; Double layer dehydrated amnion product; Other Names: Amniotic tissue allograft; Amniotic placental membranes
Active Comparator: 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.	Procedure: Standard of Care; Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings; Other Names: Debridement; Off-loading; non-adherent dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	EQ-5D survey	12 weeks
Impact of Treatment on Return to Work	Employment status e.g. full-time, part-time, retired, unemployed, etc.	12 weeks
Time to full weight bearing status	Ability of the subject to bear full weight and the time to full weight bearing	12 weeks
Adverse Events and Secondary Treatments		12 weeks
Number of grafts and graft size(s)	Number and size of grafts used at each application will be collected.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health economic outcomes	Collection of de-identified Explanation of Benefits (EOB) and/or submitted claims and/or documentation of procedures via CPT coding.	12 weeks

Collaborators and Investigators

• Sponsor: Tides Medical

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Varicose Ulcer
• Other Study ID Numbers: 16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED