Back to resultsPostmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcers
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biovance®
Standard of Care, Diabetic Foot Ulcers
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- Institute of Advanced Wound Healing
- Banner Health
- Limb Preservation Platform
- Southern California Institute for Research and Education (VA)
- Foot and Ankle Clinic
- Georgetown University
- First Coast Cardiovascular Institute
- St. Luke's Roosevelt Hospital Center
- Foot and Ankle Center at Coordinated Health
- University of Tennessee Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Biovance®
Standard of Care, Diabetic Foot Ulcers
Arm Description
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 device
Non-active moist wound treatment, debridement as needed, off-loading device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02506452
Brief Title
Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
Official Title
Evaluation of Biovance, a Dehydrated Decellularized Human Amniotic Membrane Allograft, in Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliqua BioMedical, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blinded wound core lab
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biovance®
Arm Type
Active Comparator
Arm Description
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 device
Arm Title
Standard of Care, Diabetic Foot Ulcers
Arm Type
Active Comparator
Arm Description
Non-active moist wound treatment, debridement as needed, off-loading device
Intervention Type
Other
Intervention Name(s)
Biovance®
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard of Care, Diabetic Foot Ulcers
Intervention Description
Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner
Primary Outcome Measure Information:
Title
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Institute of Advanced Wound Healing
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Banner Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Limb Preservation Platform
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Southern California Institute for Research and Education (VA)
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Foot and Ankle Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Georgetown University
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Foot and Ankle Center at Coordinated Health
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
University of Tennessee Health Sciences Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
We'll reach out to this number within 24 hrs