Trial | NCT02506452  Report issue

Title

Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
Evaluation of Biovance, a Dehydrated Decellularized Human Amniotic Membrane Allograft, in Diabetic Foot Ulcers

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Biovance® ...

  • Study Participants

    51
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 Started
Jun 30
2015
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
May 17
2017

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

Biovance® Active Comparator

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 Active Comparator

Non-active moist wound treatment, debridement as needed, off-loading device

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
No Results Posted