Clinical trial NCT03547635: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 116
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Have participated in the informed consent process and signed a study-specific informed consent document.
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:

1. The subject was previously randomized and treated under this clinical study protocol.
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.

Primary outcomes:
measure: 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.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: California 1
state: California
city: Fresno
country: United States
facility: California 3
state: California
city: Los Angeles
country: United States
facility: California 2
state: California
city: Gainesville
country: United States
facility: Georgia 1
state: Georgia
city: Springfield
country: United States
facility: Illinois 1
state: Illinois
city: Toms River
country: United States
facility: New Jersey 1
state: New Jersey
city: San Antonio
country: United States
facility: Texas 1
state: Texas
Study officials:
affiliation: Integra LifeSciences Corporation
name: Jessica Knowlton, MS CRA
role: STUDY_DIRECTOR
References:
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.
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.
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.