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

Primary Purpose

Venous Ulcer, Foot Ulcer, Diabetic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artacent Human Amniotic Membrane
Standard of Care
Sponsored by
Tides Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Global Podiatry Partners, IncRecruiting
  • Iberia Medical CenterRecruiting
  • Ochsner Clinic FoundationRecruiting
  • Foot & Ankle Center of Nebraska
  • Livingston Podiatry Associates PLLCRecruiting
  • Foot & Ankle Physicians of OhioRecruiting
  • Southwest Austin Foot & Ankle Clinic, PLLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artacent Human Amniotic Membrane

Lower Extremity Ulcer Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Wound closure
100% re-epithelialization of the wound without drainage or need for use of a dressing
Time to wound closure
# of days to 50% or greater closure
Ulcer recurrence
Telephone survey to capture number of ulcer recurrences and treatment

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2016
Last Updated
October 11, 2017
Sponsor
Tides Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02838784
Brief Title
Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers
Acronym
TMArtacent
Official Title
The Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tides Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer, Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artacent Human Amniotic Membrane
Arm Type
Experimental
Arm Description
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.
Arm Title
Lower Extremity Ulcer Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Artacent Human Amniotic Membrane
Other Intervention Name(s)
Amniotic tissue allograft, Amniotic placental membranes
Intervention Description
Double layer dehydrated amnion product
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Debridement, Off-loading, non-adherent dressings
Intervention Description
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
Primary Outcome Measure Information:
Title
Wound closure
Description
100% re-epithelialization of the wound without drainage or need for use of a dressing
Time Frame
12 weeks
Title
Time to wound closure
Description
# of days to 50% or greater closure
Time Frame
12 weeks
Title
Ulcer recurrence
Description
Telephone survey to capture number of ulcer recurrences and treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
EQ-5D survey
Time Frame
12 weeks
Title
Impact of Treatment on Return to Work
Description
Employment status e.g. full-time, part-time, retired, unemployed, etc.
Time Frame
12 weeks
Title
Time to full weight bearing status
Description
Ability of the subject to bear full weight and the time to full weight bearing
Time Frame
12 weeks
Title
Adverse Events and Secondary Treatments
Time Frame
12 weeks
Title
Number of grafts and graft size(s)
Description
Number and size of grafts used at each application will be collected.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Health economic outcomes
Description
Collection of de-identified Explanation of Benefits (EOB) and/or submitted claims and/or documentation of procedures via CPT coding.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Allen
Email
aallen@mcra.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Malchoff
Phone
6466733133
Email
nmalchoff@mcra.com
Facility Information:
Facility Name
Global Podiatry Partners, Inc
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjay Sung, DPM
Phone
626-275-2195
First Name & Middle Initial & Last Name & Degree
Amy Keyzer
Phone
626-275-2195
Facility Name
Iberia Medical Center
City
New Iberia
State/Province
Louisiana
ZIP/Postal Code
70560
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Menard, DPM
Phone
337-367-0271
First Name & Middle Initial & Last Name & Degree
Brandi Angelle
Phone
337-367-0271
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Oliver, DPM
Phone
504-842-8751
First Name & Middle Initial & Last Name & Degree
Terri Lopez
Phone
504-842-8751
Facility Name
Foot & Ankle Center of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Completed
Facility Name
Livingston Podiatry Associates PLLC
City
Bellmore
State/Province
New York
ZIP/Postal Code
11710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Livingston, DPM
Phone
516-308-4500
First Name & Middle Initial & Last Name & Degree
Donna Knepple
Phone
516-308-4500
Facility Name
Foot & Ankle Physicians of Ohio
City
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hewitt, DPM
Phone
614-782-3668
First Name & Middle Initial & Last Name & Degree
Tracy Perez
Phone
614-782-3668
Facility Name
Southwest Austin Foot & Ankle Clinic, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Whitesides, DPM
Phone
512-447-4122
First Name & Middle Initial & Last Name & Degree
Cindy Whitesides
Phone
512-447-4122

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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