Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
Evaluation of Biovance, a Dehydrated Decellularized Human Amniotic Membrane Allograft, in Diabetic Foot Ulcers
1 other identifier
interventional
51
1 country
10
Brief Summary
The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 21, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 17, 2017
May 1, 2017
2 years
July 21, 2015
May 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Wound closure observed at up to 12 weeks following baseline visit defined as 100% re-epithelialization without drainage confirmed at 2 weeks following initial observation of closure.
12 weeks
Study Arms (2)
Biovance®
ACTIVE COMPARATORApplication of Biovance® for up to 12 weeks or until wound closure, whichever is sooner. Non-active moist wound treatment, debridement as needed, off-loading device
Standard of Care, Diabetic Foot Ulcers
ACTIVE COMPARATORNon-active moist wound treatment, debridement as needed, off-loading device
Interventions
Application of Biovance® for up to 12 weeks or until wound closure, whichever is sooner. Non-active moist wound treatment, debridement as needed, off-loading
Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner
Eligibility Criteria
You may qualify if:
- The subject has:
- been diagnosed with Diabetes Mellitus (insulin or non-insulin dependent) and peripheral neuropathy (loss of protective sensation) in affected foot
- a HbA1c of less than 10% assessed within last 12 weeks
- a full-thickness diabetic neuropathic foot ulcer that is free from tunnels/sinus tracks, necrotic tissue, exposed bone and/or tendon, and osteomyelitis post debridement (Wagner 1 or 2; Appendix I)
- one (target) diabetic neuropathic foot ulcer of less than 12 months duration that has an area that measures ≥ 1.5 and ≤ 10 cm2 post debridement (max length x max width) at screening that is on any surface and part of the foot (fore-, mid- or hind-foot) with an etiology related to loss of protective sensation in that foot.
- a target ulcer that closed \<30% during the 2 week run-in period (2 weeks management with SOC following signature of informed consent prior to potential randomization)
- sufficient arterial supply to affected foot tested within the past 60 days
You may not qualify if:
- The subject has:
- ulcers of non-diabetic etiology on the study foot
- a target ulcer clinically infected or has underlying osteomyelitis at time of study treatment initiation
- clinical evidence of gangrene on any part of the affected foot
- a target ulcer with exposed bone or tendon
- any malignancy or a neoplasm at the target ulcer site
- active Charcot Foot or Charcot Foot that is unable to be offloaded (stable, non-active Charcot deformity that is able to be offloaded is acceptable)
- more than 3 ulcers on the study foot, including the target ulcer, and all other ulcers must be at least 3 cm removed from the target ulcer
- any significant comorbid disease that may interfere with wound healing
- received chemotherapy, radiotherapy, immunosuppressant or corticosteroid (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
- had the diabetic foot ulcer treated with an experimental drug/biologic/device, or a live-cell therapy (experimental or marketed), or active moist wound healing therapy within 30 days of randomization day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Institute of Advanced Wound Healing
Montgomery, Alabama, 36111, United States
Banner Health
Phoenix, Arizona, 85253, United States
Limb Preservation Platform
Fresno, California, 93721, United States
Southern California Institute for Research and Education (VA)
Long Beach, California, 90822, United States
Foot and Ankle Clinic
Los Angeles, California, 90057, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
Foot and Ankle Center at Coordinated Health
Bethlehem, Pennsylvania, 18015, United States
University of Tennessee Health Sciences Center
Memphis, Tennessee, 38103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinded wound core lab
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2015
First Posted
July 23, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
May 17, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share