Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers

NCT03589586 | Completed

• 1 other identifier: CR-18-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU).

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Healing Rate

  effect of DermACELL on the proportion of chronic venous leg ulcers that have achieved 100% re-epithelialization without drainage or dressing requirements

  16 Weeks

Secondary Outcomes (1)

• Time to wound closure

  16 Weeks

Study Arms (2)

DermACELL AWM + Conventional Care

EXPERIMENTAL

DermACELL AWM, acellular dermal matrix, plus conventional wound care- DermACELL AWM will be applied at the Baseline visit. Conventional wound care will include advanced wound dressings and multilayer compression.

Other: DermACELL AWM

Conventional Care

NO INTERVENTION

Conventional wound care will include advanced wound dressings and multilayer compression.

Interventions

DermACELL AWM OTHER

DermACELL AWM is a sterile, ready to use acellular dermal matrix

Also known as: Acellular dermal matrix

DermACELL AWM + Conventional Care

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit if the subject has a diagnosis of Type 1 or Type 2 diabetes as defined by the American Diabetes Association
• Have a full-thickness venous leg ulcer that does not penetrate into the muscle, tendon or bone.
• Have a single target ulcer
• Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
• Have a venous stasis ulcer that has been present for at least 30 days.
• Have a Clinical severity, Etiology or cause, Anatomy and Pathophysiology ulcer classification (CEAP) Grade C6: an open venous ulcer
• Have an absence of infection based on Infectious Disease Society of America criteria
• Have adequate circulation to the affected lower extremity, defined as an Ankle-brachial index (ABI) greater than 0.75.
• Have the ability to comply with off-loading (if required for specific wound), compression and dressing change requirements
• Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments
• Have provided written authorization for use and disclosure of protected health information
• Have a life expectancy of greater than 6 months

You may not qualify if:

• Be pregnant or lactating
• Have a venous leg ulcer on the dorsum of the foot or more than 50% of the ulcer is below the malleolus
• Have circulating hemoglobin A1c exceeding 12% within 90 days of the screening visit
• Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
• Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
• Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
• Have the wound treated with biomedical or topical growth factors within the previous 30 days before the screening visit
• Need for any additional concomitant dressing material other than the ones approved for this study
• Have clinical signs of an infection at the study ulcer site
• Have the inability to tolerate compression bandage
• Have a known or suspected disease of the immune system
• Have an active or untreated malignancy or active, uncontrolled connective tissue disease
• Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit
• Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
• Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit

Sponsors & Collaborators

• LifeNet Health: lead

Study Sites (7)

Arizona Regional Medical Research

Tucson, Arizona, 85710, United States

Location

Southern Arizona VA Health Care System Department of Podiatry

Tucson, Arizona, 85723, United States

Location

Limb Preservation Platform

Fresno, California, 93710, United States

Location

LA Foot and Ankle Clinic

Los Angeles, California, 90057, United States

Location

South Florida Podiatry

Deerfield Beach, Florida, 33442, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Purvis Moyer Foot and Ankle Center

Rocky Mount, North Carolina, 27804, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, controlled, open-label trial comparing DermACELL AWM to conventional care

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 18, 2018
• Study Start: June 25, 2018
• Primary Completion: January 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)