A Prospective, Multi-Center, Randomized Controlled, Parallel Group, Trial Evaluating the Use of AmnioExcel Plus Placental Allograft Membrane for the Management of Diabetic Foot Ulcers

Integra LifeSciences Corporation0 sitesSeptember 2021

ConditionsDiabetic Foot Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Integra LifeSciences Corporation
Primary Endpoint: Incidence of complete wound closure
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care (SOC) compared to SOC alone in the management of diabetic foot ulcers (DFUs).

Detailed Description

This study will have three (3) phases: (1) a Screening Phase, (2) a Treatment Phase, and (3) a Follow-up Phase. Subjects will be seen weekly in the Screening and Treatment Phases. Subjects will be seen weekly in the Screening and Treatment Phases. Subjects who achieve confirmed wound closure during the Treatment Phase will be entered into the Follow-up Phase and will return to the site four (4) weeks following that confirmation visit.

Registry

clinicaltrials.gov

Start Date

September 2021

End Date

June 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Integra LifeSciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have participated in the informed consent process and signed a study-specific informed consent document
•Be willing to comply with study procedures, including study visits, and compliance with study required off-loading/protective device for the duration of the study
•Be at least 18 years of age
•If female and of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable
•Have Type II or Type II diabetes mellitus with investigator-confirmed glycosylated hemoglobin (HbA1c) of less than or equal to 12% within 3 months prior to Screening Visit
•Have at least one diabetic foot ulcer that meets ALL the following criteria:
•Ulcer which has been in existence for a minimum of four weeks, prior to signing the Informed Consent Form allowing trial participation
•Ulcer is a partial or full thickness diabetic foot ulcer without capsule/tendon/bone exposure
•Ulcer does not have tunneling, undermining, or sinus tracts that necessitates surgical OR debridement and/or penetrates to capsule/tendon/bone
•Ulcer is located on the foot or ankle (with no portion above the top of the malleolus)

Exclusion Criteria

•Previously randomized and treated under this clinical study protocol
•Patients with a known history of poor compliance with medical treatments
•Suspected or confirmed gangrene or ulcer infection of the study ulcer or is receiving systemic/IV antibiotics at the time of randomization
•Suspected or confirmed osteomyelitis of the foot with the study ulcer
•Participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 28 days of randomization
•Received within 28 days of signing Informed Consent Form, 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 ulcer healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to the foot, vascular surgery, angioplasty, or thrombolysis)
•History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy (i.e., systemic steroids, anti-rheumatics, TNF inhibitors, active chemotherapy, immunosuppressive therapy, autoimmune disease therapy) within 12 months prior to signing Informed Consent Form allowing trial participation
•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 ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease, aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia)
•In the opinion of the investigator, the subject has unstable Charcot foot or Charcot with bony prominence that could inhibit ulcer healing
•Have ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders)

Outcomes

Primary Outcomes

Incidence of complete wound closure

Time Frame: Up to 12 weeks of treatment

Number of wounds with complete wound closure as assessed by the investigator. Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.