Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

Evaluation of Biovance, a Dehydrated Decellularized Human Amniotic Membrane Allograft, in Diabetic Foot Ulcers

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®.

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Other: Biovance®; Other: Standard of Care, Diabetic Foot Ulcers

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36111
      • Institute of Advanced Wound Healing
  • Arizona
    • Phoenix, Arizona, United States, 85253
      • Banner Health
  • California
    • Fresno, California, United States, 93721
      • Limb Preservation Platform
    • Long Beach, California, United States, 90822
      • Southern California Institute for Research and Education (VA)
    • Los Angeles, California, United States, 90057
      • Foot and Ankle Clinic
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20057
      • Georgetown University
  • Florida
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute
  • New York
    • New York, New York, United States, 10025
      • St. Luke's Roosevelt Hospital Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Foot and Ankle Center at Coordinated Health
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biovance®; 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	Other: Biovance®; 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; Other: Standard of Care, Diabetic Foot Ulcers; Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner
Active Comparator: Standard of Care, Diabetic Foot Ulcers; Non-active moist wound treatment, debridement as needed, off-loading device	Other: Standard of Care, Diabetic Foot Ulcers; Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alliqua BioMedical, Inc

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: ALQ.BIO.2015.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No