Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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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®.

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Detailed Description

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Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinded wound core lab

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Biovance®

Intervention Type OTHER

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

Standard of Care, Diabetic Foot Ulcers

Intervention Type OTHER

Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner

Standard of Care, Diabetic Foot Ulcers

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

Group Type ACTIVE_COMPARATOR

Standard of Care, Diabetic Foot Ulcers

Intervention Type OTHER

Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No