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

Study Overview
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Brief Summary
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DL-VSU-201 is a randomized, double-blind, placebo controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of Dermacyte® Amniotic Wound Care Liquid (Dermacyte® Liquid).

Detailed Description
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DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=40). The run-in phase of the study (Part 1) will enroll 10 eligible subjects. In part 1, patients will be randomized 1:1 to receive active Dermacyte once weekly or once every two weeks with standard of care. The data from Part 1 will be reviewed to determine the administration frequency of the study product (once weekly or once every two weeks) in Part 2 of the Study. In Part 2, approximately 30 subjects will be randomized 1:1 to receive Dermacyte Liquid or placebo (0.9% NaCl) with standard of care. Subjects will be followed for 12 weeks. Subjects will receive localized subcutaneous injection of Dermacyte® Liquid or placebo into and/or around the wound bed during during clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area (L X W) from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.

Official Title
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A Two Part, Randomized Study of Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers

Conditions
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Venous Stasis Ulcer, Venous Leg Ulcer

Intervention / Treatment
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* Biological: Dermacyte® Liquid (human amniotic fluid)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years of age at the time of signing informed consent Must have full thickness ulcer Ulcer surface area > 1 cm2 and < 25 cm2 Ulcer surface area has not increased or decreased by 25% or more within 14 days of Baseline Ulcer depth > 0.2 cm at the deepest point of the wound, as measured by gently inserting a pre-moistened cotton tipped applicator into the deepest part of the wound. Received > 28 days of standard of care prior to the Baseline visit. Must have adequate circulation to the affected extremity as demonstrated by ankle-brachial index (ABI) greater than or equal to 0.8 and less than or equal to 1.2 or triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg; if subject has undergone lower extremity stenting or bypass where ABI would be considered unreliable to assess microvascular circulation, subjects must have transcutaneous (TcPO2) > 40 mmHg VSU caused by underlying venous reflux disease with physiological reflux lasting greater than 500 milliseconds for superficial veins and 1.0 seconds for deep veins, as confirmed by most recent Doppler ultrasound venous mapping from Baseline; historical results within the last three years allowed Must have previously undergone venous hemodynamic correction via compression, surgical venous stripping, sclerotherapy, endovenous laser ablation and/or endovenous radiofrequency ablation Must be able to speak English Exclusion Criteria: Subject must not be currently receiving topical antimicrobials and ulcer must not be infected, 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 receiving investigational treatment Must not have underlying osteomyelitis Must not be actively receiving any skin graft substitutes or regenerative therapies within 30 days prior to Baseline Must not have chronic musculoskeletal disorders or other diseases that limit ambulation Must not be receiving oral, systemically administered corticosteroids; excluded if receiving local corticosteroid injections in the lower extremities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dermacyte® Liquid (human amniotic fluid)<br>Dermacyte® Liquid (human amniotic fluid) solution 1.0mL to 2.0mL weekly | Biological: Dermacyte® Liquid (human amniotic fluid)<br>* Subcutaneous injection into and/or around wound bed weekly<br>|
| Placebo Comparator: Placebo (0.9% saline)<br>Matching placebo solution 1.0mL to 2.0mL weekly | Biological: Dermacyte® Liquid (human amniotic fluid)<br>* Subcutaneous injection into and/or around wound bed weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Evaluated via patient and/or Investigator reported adverse events that occur during the study | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total wound closure | Total ulcer closure demonstrated by skin re-epithelization without drainage or dressing requirements at two consecutive visits > 2 weeks | Baseline to Week 12 | 
| Ulcer size | Percent reduction of the ulcer surface area | Baseline to Week 12 | 
| Change in pain | Change in patient-reported index ulcer-related pain via the score from the Visual Analogue Scale (VAS) | Baseline to Weeks 4, 8 and 12 | 
| Change in health-related quality of life | SF-36, DLQI, and Wound-QOL | Baseline to Week 12 |