Back to resultsAMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMNIOEXCEL Plus Amniotic Membrane
A Marketed Comparator
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
Eligibility Criteria
Inclusion Criteria:
- Have participated in the informed consent process and signed a study-specific informed consent document.
- Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device.
- Be ≥ 21 years of age.
- Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12%.
- Have at least one diabetic foot ulcer Ulcer size (i.e., area) is > 1 cm2 and < 12 cm2.
- Have adequate vascular perfusion of the affected limb
Exclusion Criteria:
- The subject was previously randomized and treated under this clinical study protocol.
- The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone.
- The subject is unable to safely ambulate with the use of a study required offloading boot.
- The subject has suspected or confirmed gangrene or wound infection of the study ulcer.
- The subject has suspected or confirmed osteomyelitis.
- In the opinion of the Investigator, the subject has received or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of wound healing
- The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy prior to signing the Informed Consent Form for trial participation.
- The subject is currently pregnant or is actively trying to conceive.
- In the opinion of the Investigator, the subject is unable to comply with the treatment regimen
- In the opinion of the Investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with wound healing.
- In the opinion of the Investigator, the subject has a condition that could inhibit wound healing.
- The subject has ulcers secondary to a disease other than diabetes.
Sites / Locations
- California 1
- California 3
- California 2
- Georgia 1
- Illinois 1
- New Jersey 1
- Texas 1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
AMNIOEXCEL Plus Amniotic Membrane
A Marketed Comparator
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.
Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Secondary Outcome Measures
Full Information
NCT ID
NCT03547635
First Posted
May 22, 2018
Last Updated
July 17, 2020
Sponsor
Integra LifeSciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03547635
Brief Title
AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
Official Title
A Prospective, Multi-Center, Randomized, Parallel-group Study Comparing AMNIOEXCEL Plus Placental Allograft Membrane to a Marketed Comparator and Standard of Care Procedures in the Management of Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
February 26, 2019 (Actual)
Study Completion Date
February 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMNIOEXCEL Plus Amniotic Membrane
Arm Type
Experimental
Arm Title
A Marketed Comparator
Arm Type
Active Comparator
Arm Title
Standard of Care
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
AMNIOEXCEL Plus Amniotic Membrane
Intervention Description
AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
Intervention Type
Device
Intervention Name(s)
A Marketed Comparator
Other Intervention Name(s)
Apligraf®
Intervention Description
bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Coban™
Conforming gauze
Optifoam® non-adhesive dressing
Cotton Gauze
Normal saline (liquid or gel)
Non-adhering dressings
Steristrips
An offloading boot (Pneumatic Short Leg Walker), as appropriate
Primary Outcome Measure Information:
Title
The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.
Description
Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Time Frame
Wound closure assessed up to week 12 and confirmed 2 weeks later; only participants with wound closure at or before Week 12 and who maintained closure in follow-up reported
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have participated in the informed consent process and signed a study-specific informed consent document.
Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device.
Be ≥ 21 years of age.
Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12%.
Have at least one diabetic foot ulcer Ulcer size (i.e., area) is > 1 cm2 and < 12 cm2.
Have adequate vascular perfusion of the affected limb
Exclusion Criteria:
The subject was previously randomized and treated under this clinical study protocol.
The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone.
The subject is unable to safely ambulate with the use of a study required offloading boot.
The subject has suspected or confirmed gangrene or wound infection of the study ulcer.
The subject has suspected or confirmed osteomyelitis.
In the opinion of the Investigator, the subject has received or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of wound healing
The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy prior to signing the Informed Consent Form for trial participation.
The subject is currently pregnant or is actively trying to conceive.
In the opinion of the Investigator, the subject is unable to comply with the treatment regimen
In the opinion of the Investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with wound healing.
In the opinion of the Investigator, the subject has a condition that could inhibit wound healing.
The subject has ulcers secondary to a disease other than diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Knowlton, MS CRA
Organizational Affiliation
Integra LifeSciences Corporation
Official's Role
Study Director
Facility Information:
Facility Name
California 1
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
California 3
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
California 2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90063
Country
United States
Facility Name
Georgia 1
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Illinois 1
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
New Jersey 1
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08753
Country
United States
Facility Name
Texas 1
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26978860
Citation
Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016 Mar;28(3):70-7.
Results Reference
background
PubMed Identifier
27681811
Citation
Martinson M, Martinson N. A comparative analysis of skin substitutes used in the management of diabetic foot ulcers. J Wound Care. 2016 Oct 1;25(Sup10):S8-S17. doi: 10.12968/jowc.2016.25.Sup10.S8.
Results Reference
background
PubMed Identifier
20368673
Citation
Snyder RJ, Cardinal M, Dauphinee DM, Stavosky J. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks. Ostomy Wound Manage. 2010 Mar 1;56(3):44-50.
Results Reference
background
Learn more about this trial
AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
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