Clinical trial NCT02506452: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Alliqua BioMedical, Inc
Sponsor class: INDUSTRY
First posted: 2015-07-23
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.


Eligibility criteria: Inclusion Criteria:

* The subject has:

  1. been diagnosed with Diabetes Mellitus (insulin or non-insulin dependent) and peripheral neuropathy (loss of protective sensation) in affected foot
  2. a HbA1c of less than 10% assessed within last 12 weeks
  3. 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)
  4. 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.
  5. 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)
  6. sufficient arterial supply to affected foot tested within the past 60 days

Exclusion Criteria:

* The subject has:

  1. ulcers of non-diabetic etiology on the study foot
  2. a target ulcer clinically infected or has underlying osteomyelitis at time of study treatment initiation
  3. clinical evidence of gangrene on any part of the affected foot
  4. a target ulcer with exposed bone or tendon
  5. any malignancy or a neoplasm at the target ulcer site
  6. 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)
  7. 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
  8. any significant comorbid disease that may interfere with wound healing
  9. received chemotherapy, radiotherapy, immunosuppressant or corticosteroid (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
  10. 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Institute of Advanced Wound Healing
state: Alabama
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: Fresno
country: United States
facility: Limb Preservation Platform
state: California
city: Long Beach
country: United States
facility: Southern California Institute for Research and Education (VA)
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Washington, D.C.
country: United States
facility: Georgetown University
state: District of Columbia
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: Bethlehem
country: United States
facility: Foot and Ankle Center at Coordinated Health
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Sciences Center
state: Tennessee
Study officials:
References: