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

Primary Purpose

Varicose Ulcer, Venous Insufficiency

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

AmnioExCel dressing and compression therapy

SOC alginate dressing and compression therapy

About this trial

This is an interventional treatment trial for Varicose Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Greenville Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

SOC alginate dressing

AmnioExCel dressing

Arm Description

SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement

AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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"

Full Information

NCT ID

NCT02929056

First Posted

October 7, 2016

Last Updated

November 19, 2021

Sponsor

Prisma Health-Upstate

Collaborators

Clemson University, BioDlogics

1. Study Identification

Unique Protocol Identification Number

NCT02929056

Brief Title

Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations

Acronym

AmnioExCel

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

grant funding ended

Study Start Date

February 15, 2017 (Actual)

Primary Completion Date

September 6, 2018 (Actual)

Study Completion Date

October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Prisma Health-Upstate

Collaborators

Clemson University, BioDlogics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicose Ulcer, Venous Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOC alginate dressing

Arm Type

Placebo Comparator

Arm Description

SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement

Arm Title

AmnioExCel dressing

Arm Type

Experimental

Arm Description

AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement

Intervention Type

Biological

Intervention Name(s)

AmnioExCel dressing and compression therapy

Intervention Description

Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers

Intervention Type

Procedure

Intervention Name(s)

SOC alginate dressing and compression therapy

Intervention Description

Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing

Primary Outcome Measure Information:

Title

Change in Wound Area

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Patient Pain Score

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Oliver, MD

Organizational Affiliation

Prisma Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Greenville Health System

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations

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