Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

Not Applicable

• Conditions: Diabetic Foot Ulcers
• Interventions: Other: Biovance®; Other: Standard of Care, Diabetic Foot Ulcers

• Registration Number: NCT02506452
• Lead Sponsor: Alliqua BioMedical, Inc

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biovance®	Standard of Care, Diabetic Foot Ulcers	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
Standard of Care, Diabetic Foot Ulcers	Standard of Care, Diabetic Foot Ulcers	Non-active moist wound treatment, debridement as needed, off-loading device
Biovance®	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

First Coast Cardiovascular Institute; 🇺🇸 Jacksonville, Florida, United States

University of Tennessee Health Sciences Center; 🇺🇸 Memphis, Tennessee, United States

Institute of Advanced Wound Healing; 🇺🇸 Montgomery, Alabama, United States

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States

Georgetown University; 🇺🇸 Washington, D.C., District of Columbia, United States

Foot and Ankle Center at Coordinated Health; 🇺🇸 Bethlehem, Pennsylvania, United States

Foot and Ankle Clinic; 🇺🇸 Los Angeles, California, United States

Banner Health; 🇺🇸 Phoenix, Arizona, United States

Southern California Institute for Research and Education (VA); 🇺🇸 Long Beach, California, United States

Limb Preservation Platform; 🇺🇸 Fresno, California, United States