Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations (AmnioExCel)

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

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™.

Study Overview

• Status: Terminated
• Conditions: Venous Insufficiency; Varicose Ulcer
• Intervention / Treatment: Procedure: SOC alginate dressing and compression therapy; Biological: AmnioExCel dressing and compression therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, 18 years or older
2. At least one VLU with a total surface area between 2 cm2 and 100 cm2
3. VLU present for at least 1 month
4. Presence of a VLU extending through the full thickness of the skin but not down to muscle, tendons, or bones
5. Ulcer has a clean, granulating base with minimal adherent slough
6. VLU has been treated with compression therapy for at least 14 days
7. The study VLU has < 30% area reduction with SOC treatment for the duration ≥ 2 weeks screening period

8. 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
9. Willingness to comply with the protocol, attend all follow-up visits, complete all protocol related assessments and provide informed consent

Exclusion Criteria:

1. Presence of an active infection of the skin on the target limb such as cellulitis requiring antibiotics
2. Ulcer caused by a medical condition other than venous insufficiency
3. Ulcer suspicious for cancer
4. Known history of AIDS or HIV
5. 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.
6. Receipt of a biologic agent, growth factor or skin substitute within the prior 30 days
7. Known sensitivity to ethanol
8. Uncontrolled diabetes mellitus with a HgBA1c of > 10% within the past 3 months
9. Rheumatoid arthritis
10. Significant lower extremity arterial occlusive disease that would preclude the use of compression therapy
11. NYHA Class III and IV congestive heart failure (CHF)
12. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus
13. Currently receiving radiation therapy or chemotherapy
14. Receiving immune modulators
15. Currently pregnant or trying to get pregnant
16. Breast feeding
17. Not willing to provide written informed consent or remain in compliance with the study protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Clemson University; BioDlogics
• Investigators: Principal Investigator: Thomas Oliver, MD, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): September 6, 2018
• Study Completion (Actual): October 29, 2019

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: 00059274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected from participants who sign consent will be sent in a de-identified fashion to Clemson University for data analysis. Clemson University will submit safety information to BioDLogics, LLC, in a de-identified fashion as appropriate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes