Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management of Chronic Diabetic Foot Ulcers
1 other identifier
interventional
29
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 2, 2017
November 1, 2017
1.1 years
July 31, 2014
November 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment
8 weeks
Secondary Outcomes (4)
Time to complete wound closure of the target ulcer
8 weeks
Rate of wound closure
8 Weeks
Incidence, severity and type of adverse events
8 Weeks
Changes in Quality of Life assessment
8 Weeks
Study Arms (2)
AMNIOEXCEL
ACTIVE COMPARATORHuman Amniotic Membrane Allograft
Standard of Care, Diabetic Foot Ulcers
ACTIVE COMPARATORAdvanced wound care dressings and offloading of wound.
Interventions
Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, 85015, United States
Center for Clinical Research, Inc.
Castro Valley, California, 94546, United States
Pacific Wound Center
Stockton, California, 95204, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216, United States
Barry University Clinical Research
North Miami Beach, Florida, 33169, United States
Beth Israel Deaconess Hospital - Plymouth
Plymouth, Massachusetts, 02360, United States
Duke University
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27533, United States
Related Publications (1)
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.
PMID: 26978860DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 5, 2014
Study Start
July 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
December 2, 2017
Record last verified: 2017-11