AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
NCT ID: NCT03547635
Last Updated: 2020-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2018-05-03
2019-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AMNIOEXCEL Plus Amniotic Membrane
AMNIOEXCEL Plus Amniotic Membrane
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.
A Marketed Comparator
A Marketed Comparator
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.
Standard of Care
Standard of Care
* 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
Interventions
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AMNIOEXCEL Plus Amniotic Membrane
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.
A Marketed Comparator
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.
Standard of Care
* 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device.
3. Be ≥ 21 years of age.
4. Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12%.
5. Have at least one diabetic foot ulcer Ulcer size (i.e., area) is \> 1 cm2 and \< 12 cm2.
6. Have adequate vascular perfusion of the affected limb
Exclusion Criteria
2. The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone.
3. The subject is unable to safely ambulate with the use of a study required offloading boot.
4. The subject has suspected or confirmed gangrene or wound infection of the study ulcer.
5. The subject has suspected or confirmed osteomyelitis.
6. 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
7. 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.
8. The subject is currently pregnant or is actively trying to conceive.
9. In the opinion of the Investigator, the subject is unable to comply with the treatment regimen
10. 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.
11. In the opinion of the Investigator, the subject has a condition that could inhibit wound healing.
12. The subject has ulcers secondary to a disease other than diabetes.
21 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jessica Knowlton, MS CRA
Role: STUDY_DIRECTOR
Integra LifeSciences Corporation
Locations
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California 1
Fresno, California, United States
California 3
Fresno, California, United States
California 2
Los Angeles, California, United States
Georgia 1
Gainesville, Georgia, United States
Illinois 1
Springfield, Illinois, United States
New Jersey 1
Toms River, New Jersey, United States
Texas 1
San Antonio, Texas, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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T-AEPDFU-001
Identifier Type: -
Identifier Source: org_study_id
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