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

• Sponsor: Prisma Health-Upstate (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02929056
• Collaborator: Clemson University (Other), BioDlogics (Industry)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.4
• Patients Per Site Per Month: 0.1

Study Details

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™.

Condition or Disease	Intervention/Treatment	Phase
Varicose Ulcer; Venous Insufficiency	Biological: AmnioExCel dressing and compression therapy; Procedure: SOC alginate dressing and compression therapy	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Comparative Parallel Study of Amniotic Membrane in the Management of Venous Leg Ulcerations
• Actual Study Start Date: Feb 15, 2017
• Actual Primary Completion Date: Sep 6, 2018
• Actual Study Completion Date: Oct 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Wound Area [12 weeks]

   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

1. Change in Patient Pain Score [12 weeks]

   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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Greenville Health System	Greenville	South Carolina	United States	29615

Sponsors and Collaborators

• Prisma Health-Upstate
• Clemson University
• BioDlogics

Investigators

• Principal Investigator: Thomas Oliver, MD, Prisma Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 22, 2016

More Information

Publications

None provided.

• Responsible Party: Prisma Health-Upstate
• ClinicalTrials.gov Identifier: NCT02929056
• Other Study ID Numbers: 00059274
• First Posted: Oct 10, 2016
• Last Update Posted: Dec 16, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Venous Insufficiency; Varicose Ulcer

Study Results

Participant Flow

Arm/Group Title	SOC Alginate Dressing	AmnioExCel Dressing
Arm/Group Description	SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement 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	AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement 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
Period Title: Overall Study
STARTED	1	1
COMPLETED	1	0
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	SOC Alginate Dressing	AmnioExCel Dressing	Total
Arm/Group Description	SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement 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	AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement 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	Total of all reporting groups
Overall Participants	1	1	2
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 100%	0 0%	1 50%
>=65 years	0 0%	1 100%	1 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52	70	61 (0)
Sex: Female, Male (Count of Participants)
Female	1 100%	0 0%	1 50%
Male	0 0%	1 100%	1 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 100%	1 100%	2 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	1 100%	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOC Alginate Dressing	AmnioExCel Dressing
Arm/Group Description	SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement 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	AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement 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
Measure Participants	1	1
Number [percentage of change]	2.94	-31.58

2. Secondary Outcome

Title	Change in Patient Pain Score
Description	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"
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOC Alginate Dressing	AmnioExCel Dressing
Arm/Group Description	SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement 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	AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement 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
Measure Participants	1	1
Number [percent of change]	-100	-100

Adverse Events

Time Frame	2.5 years
Arm/Group Title	SOC Alginate Dressing		AmnioExCel Dressing
Arm/Group Description	SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement 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		AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement 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
All Cause Mortality
	SOC Alginate Dressing		AmnioExCel Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/1 (100%)		1/1 (100%)
Serious Adverse Events
	SOC Alginate Dressing		AmnioExCel Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	SOC Alginate Dressing		AmnioExCel Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		1/1 (100%)
Skin and subcutaneous tissue disorders
contralateral leg venous ulcer infection	0/1 (0%)	0	1/1 (100%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.