Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers

Inclusion Criteria:

• Subjects who voluntary give written informed consent to participate in study

• Males and female subjects aged 18 to 75 years inclusive at Screening (date thesubject provides written informed consent to participate in study) for Part 1 only

• Males and female subjects aged 18 to 80 years inclusive at Screening (date thesubject provides written informed consent to participate in study) for Part 2 only

• Subjects must have a full thickness ulcer that meets the following criteria:

• Ulcer surface area > 1 cm2 and < 25 cm2

• Ulcer surface area hasn't increased or decreased by 25% or more, as assessedwithin 14 days or more prior to Baseline

• Ulcer depth > 0.2 cm at the deepest point of the wound, as measured by gentlyinserting a pre-moistened cotton tipped applicator into the deepest part of thewound.

• Ulcer age < 12 months (365 days) prior to Baseline (for Part 2 only)

• Received > 28 days of standard, conventional wound therapy with a high-compression,multilayer bandaging (e.g. compression hose, custom garments, commercial kits, etc.)prior to the Baseline visit. If clinically necessary, subjects may have receivedother wound treatments as needed (e.g., surgical debridement, pressure off-loading,negative pressure and/or hyperbaric oxygen therapy).

• Subjects must have previously undergone venous hemodynamic correction viacompression, surgical venous stripping, sclerotherapy, endovenous laser ablation,and/or endovenous radiofrequency ablation.

• Subjects must have adequate circulation to the affected extremity as demonstrated bythe most recently measured ankle-brachial index (ABI) greater than or equal to 0.8and less than or equal to 1.2 or triphasic or biphasic Doppler arterial waveforms atthe ankle of the affected leg (as applicable). If subject has undergone lowerextremity stenting or bypass where ABI would be considered unreliable to assessmicrovascular circulation, subjects must have transcutaneous oximetry (TcPO2) > 40mmHg.

• Subjects must have VSU caused by underlying venous reflux disease with physiologicalreflux lasting greater than 500 milliseconds for superficial veins and 1.0 secondsfor deep veins, as confirmed by most recent Doppler ultrasound venous mapping fromBaseline; historical results/confirmation within the previous three years allowed.

• Subjects who agree to follow the specified precautions to avoid pregnancy asfollows:

Subjects who are females of childbearing potential include any female subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). For female subjects of childbearing potential, a negative urine pregnancy test is required at Screening and Baseline prior to initiating Study Product. Female subjects of childbearing potential must follow 1 of the following approaches:

• Practice actual abstinence from intercourse

• Have a partner with a vasectomy

• Have an intrauterine device

• Must use 2 different forms of highly effective contraception for the duration of thestudy, and for at least 48 hours after discontinuing study drug. Medicallyacceptable forms of effective contraception include approved hormonal contraceptives (such as birth control pills) or barrier methods (such as a condom or diaphragm).

• Male subjects with a partner of childbearing potential must use a condom duringintercourse for the duration of the study, and for 48 hours after discontinuingstudy drug.

• Subjects who, in the opinion of the Investigator, are capable ofcommunicating effectively with study personnel and are consideredreliable, willing, and likely to be cooperative with protocol requirementsand attend all required study visits.

• Subjects who have the capability to answer surveys and questionnaireswritten in English.

Exclusion Criteria:

• Subject must not be currently receiving topical antimicrobials and ulcer must not beinfected as determined by clinical assessment (e.g. odor, color, visual appearance)rather than culture.

• Ulcer must not have exposed bone, tendon, or ligament.

• Subject must not have another ulcer within 3 cm from the ulcer receivinginvestigational treatment.

• Female subjects who are pregnant, lactating, or planning to become pregnant duringthe study.

• Subjects actively receiving or received a skin graft substitutes within 30 daysprior to Baseline.

• Subjects receiving oral, systemically administered, or lower extremity injectablecorticosteroid therapy within 60 days prior to Baseline.

Subjects with angiographic or clinical signs of peripheral arterial disease (PAD) or congestive heart failure (CHF) with most previous echocardiogram demonstrating an ejection fraction (EF) less than 35%.

• Subjects with underlying osteomyelitis.

• Subjects with an active infection or condition that would interfere withinterpretation of study assessments.

• Subjects with an HbA1c > 7.0% (Part 1 only) or HbA1c > 8.0% (Part 2 only), ascollected at Screening or in the previous 120 days prior to Screening.

• Subjects with current deep vein thrombosis (DVT) (Part 2 only)

• Subjects with chronic musculoskeletal disorder or any other disease that would limitambulation.

• Subjects with a history of alcohol abuse or illicit drug abuse within 12 months ofBaseline which, in the Investigator's opinion, would make the subject inappropriatefor enrollment in a clinical study.

• Subjects with any other concomitant disease with life expectancy of <12 months fromBaseline

• Subjects with an unstable psychiatric condition or those not capable ofunderstanding the objectives, nature, or consequences of the study, or who have anycondition which, in the Investigator's opinion, would constitute an unacceptablerisk to the subject's safety.

• Subjects who are currently receiving an investigational drug, have aninvestigational device in place, or who have participated in an investigational drugor device study within 90 days prior to Baseline. Participation in an observationalstudy within 90 days prior to Baseline does not disqualify a subject from enrolling.

• Subjects who have received another regenerative therapy within 30 days prior toBaseline.

• Subjects with a Body Mass Index (BMI) > 45 (Part 2 only).