DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044132
• Other study ID #: CR-16-002
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: LifeNet Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.

Description:

This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification 3 and 4).

A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic for up to 16 weeks.

The specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. The time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM) and safety data will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)

• target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)

• target wound that is not amendable to primary closure

• target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial

• adequate perfusion to the extremity

• laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control)

Exclusion Criteria:

• untreated infection of soft tissue or bone

• untreated autoimmune connective tissue disorders

• body mass index (BMI) of = 50

• undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication

• active liver disease (e.g. hepatitis A-G),

• have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment

• pregnant

• enrolled in any other interventional clinical research trial

• an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Lower Extremity Wound
• Ulcer

Intervention

Other:
• DermACELL AWM
Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology

Locations

Country	Name	City	State
United States	Limb Preservation Platform	Fresno	California
United States	Purvis Moyer Foot and Ankle Center	Rocky Mount	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
LifeNet Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).	Days required for granular bed formation	112 Days
Secondary	Number of applications of study product required to achieve granulation.		16 Weeks
Secondary	Percent wound area reduction and percent complete wound closure at 16 Weeks.		16 Weeks
Secondary	The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.		16 Weeks