Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02506452
• Other study ID #: ALQ.BIO.2015.01
• Status: Active, not recruiting
• Phase: N/A
• First received: July 21, 2015
• Last updated: May 15, 2017
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Alliqua BioMedical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Foot and Ankle Center at Coordinated Health	Bethlehem	Pennsylvania
United States	Limb Preservation Platform	Fresno	California
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Southern California Institute for Research and Education (VA)	Long Beach	California
United States	Foot and Ankle Clinic	Los Angeles	California
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	Banner Health	Phoenix	Arizona
United States	Georgetown University	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Alliqua BioMedical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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