AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

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Integra LifeSciences

Status

Completed

Conditions

Diabetic Foot Ulcer

Treatments

Other: Standard of Care
Other: AMNIOEXCEL Plus Amniotic Membrane
Device: A Marketed Comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT03547635
T-AEPDFU-001

Details and patient eligibility

About

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).

Enrollment

116 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

116 participants in 3 patient groups

AMNIOEXCEL Plus Amniotic Membrane
Experimental group
Treatment:
Other: AMNIOEXCEL Plus Amniotic Membrane
A Marketed Comparator
Active Comparator group
Treatment:
Device: A Marketed Comparator
Standard of Care
Other group
Treatment:
Other: Standard of Care

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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