The Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tides Medical
- Enrollment
- 134
- Locations
- 7
- Primary Endpoint
- Time to wound closure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Artacent Human Amniotic Membrane (Other)
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.
Intervention: Standard of Care (Procedure)
Outcomes
Primary Outcomes
Time to wound closure
Time Frame: 12 weeks
# of days to 50% or greater closure
Ulcer recurrence
Time Frame: 6 months
Telephone survey to capture number of ulcer recurrences and treatment
Wound closure
Time Frame: 12 weeks
100% re-epithelialization of the wound without drainage or need for use of a dressing
Secondary Outcomes
- Quality of Life(12 weeks)
- Adverse Events and Secondary Treatments(12 weeks)
- Number of grafts and graft size(s)(12 weeks)
- Impact of Treatment on Return to Work(12 weeks)
- Time to full weight bearing status(12 weeks)