Trial Outcomes & Findings for Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations (NCT NCT02929056)

NCT ID: NCT02929056

Last Updated: 2021-12-16

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-12-16

Participant Flow

Participant milestones

Measure	SOC Alginate Dressing 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 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
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	SOC Alginate Dressing 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 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
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations

Baseline characteristics by cohort

Measure	SOC Alginate Dressing n=1 Participants 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 n=1 Participants 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 n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants	70 years n=7 Participants	61 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	SOC Alginate Dressing n=1 Participants 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 n=1 Participants 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
Change in Wound Area	2.94 percentage of change	-31.58 percentage of change

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	SOC Alginate Dressing n=1 Participants 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 n=1 Participants 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
Change in Patient Pain Score	-100 percent of change	-100 percent of change

Adverse Events

SOC Alginate Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

AmnioExCel Dressing

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SOC Alginate Dressing n=1 participants at risk 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 n=1 participants at risk 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
Skin and subcutaneous tissue disorders contralateral leg venous ulcer infection	0.00% 0/1 • 2.5 years	100.0% 1/1 • Number of events 1 • 2.5 years

Additional Information

Dr. Thomas Oliver

Prisma Health

Phone: 864-454-8272

Email: Tom.Oliver@prismahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place