Back to resultsDermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer, Lower Extremity Wound
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DermACELL AWM
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, DFU, Lower Extremity Wound, Skin Substitute
Eligibility Criteria
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.
Sites / Locations
- Limb Preservation Platform
- Purvis Moyer Foot and Ankle Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DermACELL AWM
Arm Description
Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use.
Outcomes
Primary Outcome Measures
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
Days required for granular bed formation
Secondary Outcome Measures
Number of applications of study product required to achieve granulation.
Percent wound area reduction and percent complete wound closure at 16 Weeks.
The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03044132
Brief Title
DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Official Title
A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeNet Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Lower Extremity Wound
Keywords
Diabetic Foot Ulcer, DFU, Lower Extremity Wound, Skin Substitute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DermACELL AWM
Arm Type
Experimental
Arm Description
Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use.
Intervention Type
Other
Intervention Name(s)
DermACELL AWM
Intervention Description
Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology
Primary Outcome Measure Information:
Title
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
Description
Days required for granular bed formation
Time Frame
112 Days
Secondary Outcome Measure Information:
Title
Number of applications of study product required to achieve granulation.
Time Frame
16 Weeks
Title
Percent wound area reduction and percent complete wound closure at 16 Weeks.
Time Frame
16 Weeks
Title
The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Limb Preservation Platform
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Purvis Moyer Foot and Ankle Center
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31361269
Citation
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. doi: 10.1097/01.ASW.0000569132.38449.c0.
Results Reference
result
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DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
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