Status:
COMPLETED
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
Detailed Description
Potential study candidates will be Screened for Inclusion and Exclusion criteria after providing informed consent. Candidates will have their wound cleansed and debrided (if necessary), photographed a...
Eligibility Criteria
Inclusion
- an ambulatory person at least 18 years of age at the time of informed consent.
- type 1 or type 2 diabetes mellitus.
- glycosylated hemoglobin (HbA1c) of ≤12%
- at least one wound that is/has:
- Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
- duration of at least 1 month,
- no clinical signs of infection or osteomyelitis,
- between 1cm2 and 25cm2 in area,
- per original protocol, closed \<20% in area during the Screening Period; per Amendment #1, closed \<30% in area during Screening and
- located on the foot, distal to malleoli.
- adequate circulation to the affected extremity
- serum creatinine of \<3.0mg/dl.
Exclusion
- participated in another clinical trial within 30 days prior to consent,
- Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
- receiving radiation or chemotherapy of any kind,
- known or suspected malignancy of current ulcer,
- pregnant or breast feeding,
- an active malignant disease,
- receiving hemo- or peritoneal dialysis,
- sickle cell anemia or Raynaud's syndrome,
- diagnosis of autoimmune connective tissue disease,
- received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
- exposed bone, tendon or joint capsule in the study ulcer,
- currently receiving antibiotics (for any reason), or
- taking medications considered to be immune system modulators.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02209051
Start Date
July 1 2014
End Date
August 1 2015
Last Update
December 2 2017
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015
2
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
3
Pacific Wound Center
Stockton, California, United States, 95204
4
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216