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

Foot Ulcer, Diabetic Clinical Trial

— TMArtacent  

Official title:

The Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838784
• Other study ID #: 16-001
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: October 11, 2017
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: Tides Medical
• Contact: Abigail Allen
• Email: aallen[@]mcra.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Other:
• Artacent Human Amniotic Membrane
Double layer dehydrated amnion product

Procedure:
• Standard of Care
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings

Locations

Country	Name	City	State
United States	Global Podiatry Partners, Inc	Arcadia	California
United States	Southwest Austin Foot & Ankle Clinic, PLLC	Austin	Texas
United States	Livingston Podiatry Associates PLLC	Bellmore	New York
United States	Foot & Ankle Physicians of Ohio	Grove City	Ohio
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

Sponsors (1)

Lead Sponsor	Collaborator
Tides Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Wound closure	100% re-epithelialization of the wound without drainage or need for use of a dressing	12 weeks
Primary	Time to wound closure	# of days to 50% or greater closure	12 weeks
Primary	Ulcer recurrence	Telephone survey to capture number of ulcer recurrences and treatment	6 months
Secondary	Quality of Life	EQ-5D survey	12 weeks
Secondary	Impact of Treatment on Return to Work	Employment status e.g. full-time, part-time, retired, unemployed, etc.	12 weeks
Secondary	Time to full weight bearing status	Ability of the subject to bear full weight and the time to full weight bearing	12 weeks
Secondary	Adverse Events and Secondary Treatments		12 weeks
Secondary	Number of grafts and graft size(s)	Number and size of grafts used at each application will be collected.	12 weeks