Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2015
End Date:December 2016
Contact:Helen Hahn, RN BSN MBA
Email:hhahn@alliqua.com
Phone:215-702-3733

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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®.


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
We found this trial at
2
sites
Los Angeles, California 90010
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from
Los Angeles, CA
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Montgomery, Alabama 36111
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from
Montgomery, AL
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