Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare healing characteristics, reduction in the size of the wound and to measure complete healing of the wound following the application of a biologic product dressing instead of the alginate dressing along with standard debridement and compression therapy versus the standard of care treatment for VLUs. The biologic product that will be used in this study is called AmnioExCel™.

Detailed Description
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Approximately 40 participants will be enrolled in this study at the Greenville Health System. Participation is anticipated to last up to 15 weeks and will include a two week screening period, randomization (Visit 1) and office visits at the study doctor's office once every week for up to 12 weeks (Visit 2 - Visit 12). All participants will receive the standard of care wound treatment during the 2 week screening period. The treatment plan outlined in treatment group 1 or treatment group 2 will be followed after randomization. Participants will be randomly assigned (like flipping a coin) into one of two treatment groups. There is an equal chance to be enrolled into either of the two treatment groups. Neither the participant nor the study doctor can control the group assignment. Treatment Group 1: participants will receive the standard of care treatment including the use of a multi-layer compression wrap for their VLU. Treatment Group 2: participants will receive the application of the biologic product AmnioExCel™ dressing instead of the application of an alginate dressing in addition to standard debridement and the use of a multi-layer compression wrap for their VLU. If participants have more than one VLU, only one will be enrolled in the study and will receive the application of the AmnioExCel™ dressing. The remaining VLUs will receive the application of the alginate dressing. AmnioExCel™ is a human cellular and tissue based product that is registered with the United States Food and Drug Administration (FDA). It is intended for use as a wound covering and is made of a dehydrated human amniotic membrane (innermost layer of the placenta) that was obtained from donated human placenta. The use of AmnioExCel™ specifically for this study is not considered as standard of care.

Official Title
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A Prospective Randomized Comparative Parallel Study of Amniotic Membrane in the Management of Venous Leg Ulcerations

Conditions
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Varicose Ulcer, Venous Insufficiency

Intervention / Treatment
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* Biological: AmnioExCel dressing and compression therapy
* Procedure: SOC alginate dressing and compression therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years or older At least one VLU with a total surface area between 2 cm2 and 100 cm2 VLU present for at least 1 month Presence of a VLU extending through the full thickness of the skin but not down to muscle, tendons, or bones Ulcer has a clean, granulating base with minimal adherent slough VLU has been treated with compression therapy for at least 14 days The study VLU has < 30% area reduction with SOC treatment for the duration ≥ 2 weeks screening period At least one of the following within the last 6 months: An Ankle-Brachial Index (ABI) of > 0.75 Dorsalis Pedis (DP) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb Posterior Tibial (PT) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb Great toe systolic pressure ≥ 40 mm Hg Willingness to comply with the protocol, attend all follow-up visits, complete all protocol related assessments and provide informed consent Exclusion Criteria: Presence of an active infection of the skin on the target limb such as cellulitis requiring antibiotics Ulcer caused by a medical condition other than venous insufficiency Ulcer suspicious for cancer Known history of AIDS or HIV Previously treated with tissue engineered materials (e.g., Apligraft, Dermagraft or EpiFix) or other scaffold materials (e.g., Oasis or Puraply) in the past three months on the target VLU. Receipt of a biologic agent, growth factor or skin substitute within the prior 30 days Known sensitivity to ethanol Uncontrolled diabetes mellitus with a HgBA1c of > 10% within the past 3 months Rheumatoid arthritis Significant lower extremity arterial occlusive disease that would preclude the use of compression therapy NYHA Class III and IV congestive heart failure (CHF) Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus Currently receiving radiation therapy or chemotherapy Receiving immune modulators Currently pregnant or trying to get pregnant Breast feeding Not willing to provide written informed consent or remain in compliance with the study protocol requirements

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: SOC alginate dressing<br>SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement | Procedure: SOC alginate dressing and compression therapy<br>* Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing<br>|
| Experimental: AmnioExCel dressing<br>AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement | Biological: AmnioExCel dressing and compression therapy<br>* Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wound Area | Average percent change in wound area, computed with respect to wound area at time 0. Wound area assessed at baseline (time 0) and then weekly; change from baseline to 12 weeks reported. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Pain Score | Pain assessed at weekly visits using the Wong-Baker FACES (Family And Caregiver Education & Support) Pain Scale. Change from baseline to 12 weeks reported. Self-report measure of pain from 0 to 10, with higher values representing a worse outcome. 0 = No hurt and 10 = Hurts Worst | 12 weeks |