Foot Ulcer, Diabetic, Venous Ulcer
Conditions
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.
Interventions
OTHERArtacent Human Amniotic Membrane
Double layer dehydrated amnion product
PROCEDUREStandard of Care
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
Sponsors
Tides Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer recurrence | 6 months | Telephone survey to capture number of ulcer recurrences and treatment |
| Wound closure | 12 weeks | 100% re-epithelialization of the wound without drainage or need for use of a dressing |
| Time to wound closure | 12 weeks | \# of days to 50% or greater closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to full weight bearing status | 12 weeks | Ability of the subject to bear full weight and the time to full weight bearing |
| Number of grafts and graft size(s) | 12 weeks | Number and size of grafts used at each application will be collected. |
| Adverse Events and Secondary Treatments | 12 weeks | — |
| Quality of Life | 12 weeks | EQ-5D survey |
| Impact of Treatment on Return to Work | 12 weeks | Employment status e.g. full-time, part-time, retired, unemployed, etc. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health economic outcomes | 12 weeks | Collection of de-identified Explanation of Benefits (EOB) and/or submitted claims and/or documentation of procedures via CPT coding. |
Countries
United States
Contacts
Primary ContactAbigail Allen
Backup ContactNancy Malchoff
Outcome results
None listed