This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone.
This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.
Patient has signed the informed consent form.
Male or female patient at least 18 years of age or older, as of the date of the screening visit.
Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
If the subject presents with > 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
Clinical evidence of ulcer bed infection, or infected hardware.
Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
Parallel
BR-AC
Other interventionBR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization.
Standard Care
Other interventionStandard Care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg.
To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone.
Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure
Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization
To compare differences between treatment groups in percent change in wound area (cm2)
Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization
To determine the total number of applications of BR-AC needed to achieve complete wound closure
Percent change from baseline in wound volume (cm3) at 12-weeks post-randomization
To determine whether subjects that crossover and receive standard care plus BR-AC results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone
Time in days from Visit 18 to initial observation of wound closure (defined as 100% reepithelialization of the wound without drainage) over an additional 12 weeks (Visits 19-30), where healing has been confirmed at two visits two weeks apart
Number of participants that acquire clinical signs and symptoms of infections post-randomization
Differences in clinical signs and symptoms of infection from Visit 2 through end of study between the treatment groups
Proportion of subjects experiencing adverse events, by treatment group
Spontaneously reported and elicited adverse events, coded in MedDRA
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