NCT02929056

Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Varicose Ulcer
• Venous Insufficiency

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2017-02-15
• Primary completion: 2018-09-06
• Completion: 2019-10-29
• First posted: 2016-10-10
• Last updated: 2021-12-16
• Results posted: 2021-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study