A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Study is estimated to require 12 months from first subject enrolled to last subject visit.
Diabetic foot ulcers (DFUs) challenge the most experienced wound care specialist. The US Wound Registry reports that only 40% of DFUs heal in 12 weeks1. Woundologists have adopted the phrase, "time is tissue." This adage reminds clinicians that the longer a DFU remains open, the greater the risk of infection, major amputation and death. The diabetic with a foot ulcer has a mortality rate of 47% which exceeds the mortality2 from most common cancers3. Beyond patient suffering, the treatment of DFUs cost the US health care system more than 15 billion dollars annually4. In recent years, several clinical trials have demonstrated that products derived from human placental membranes promote the healing of DFUs5. Research has confirmed that growth factors present in amniotic membrane induce angiogenesis, stimulate human dermal fibroblast proliferation, and recruit stem cells important to wound repair and regeneration to the DFU6. All these factors are highly desirable properties in the healing of chronic DFUs. A novel dual layer amniotic membrane (DLAM, Artacent™, Tides Medical. Lafayette, LA) potentially can increase the delivery of growth factors due to its double layer of amniotic membrane. A prospective case series demonstrated good healing rates in DFUs: 65% healing at 12 weeks7. The current study is the first randomized clinical trial evaluating the efficacy of DLAM in DFUs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized. Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.
Titan Research
Phoenix, Arizona, United States
RECRUITINGNew Hope Podiatry
Complete Wound Closure
\- The percentage of target ulcers achieving complete wound closure in 12 weeks
Time frame: 1-12 weeks
Percentage Wound Area Reduction
\- Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination
Time frame: 1-12 weeks
Adverse Events
The number of adverse events
Time frame: 1-12 weeks
Percentage of time wearing offloading boot
\- Compliance with a prescribed offloading boot measured as % of time wearing the boot
Time frame: 1-12 Weeks
Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine
\- Change in pain in the target ulcer assessed using the PEG scale. \[Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit\]
Time frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit
Changes in bacterial Load
\- Exploratory Endpoint: changes in bacterial load measured using fluorescence imaging
Time frame: 1-12 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Los Angeles, California, United States
Royal Research
Pembroke Pines, Florida, United States
RECRUITINGPharma Research Associates
Westchester, Florida, United States
COMPLETEDRegional Infectious Disease and Infusion Center, Inc
La Grange, Georgia, United States
RECRUITINGHoosier Foot and Ankle
Fishers, Indiana, United States
RECRUITINGSerena Group Baton Rouge
Baton Rouge, Louisiana, United States
RECRUITINGOpelousas Medical Research Consultants, LLC
Opelousas, Louisiana, United States
RECRUITINGMount Sinai St. Luke's Hospital
New York, New York, United States
RECRUITINGCleveland Foot and Ankle Clinic
Cleveland, Ohio, United States
RECRUITING...and 6 more locations