Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations

NCT02929056 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 00059274
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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™.

Conditions

Varicose Ulcer; Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Patient Pain Score

  12 weeks

Study Arms (2)

SOC alginate dressing

PLACEBO COMPARATOR

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

AmnioExCel dressing

EXPERIMENTAL

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

Biological: AmnioExCel dressing and compression therapy

Interventions

AmnioExCel dressing and compression therapy BIOLOGICAL

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

AmnioExCel dressing

SOC alginate dressing and compression therapy PROCEDURE

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

SOC alginate dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Clemson University: collaborator
• BioDlogics: collaborator

Study Sites (1)

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Venous Insufficiency

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Thomas Oliver
• Organization: Prisma Health

Tom.Oliver@prismahealth.org

864-454-8272

Study Officials

• Thomas Oliver, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 10, 2016
• Study Start: February 15, 2017
• Primary Completion: September 6, 2018
• Study Completion: October 29, 2019
• Last Updated: December 16, 2021
• Results First Posted: December 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)