Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study.

Official Title
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The Clinical & Economic Evaluation of Bio-ConneKt® Wound Dressing in Treating Chronic Foot Ulcers (Diabetic and/or Venous Ulcers).

Conditions
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Skin Ulcer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale) or a venous leg ulcer confirmed with duplex ultrasound The ulcer has been diagnosed/present for greater than 4 weeks duration. Three or fewer ulcers separated by > 3.0 cm distance Post-debridement, the ulcer size must be > 5 sq cm Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present: transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) At least 18 years old Able and willing to read and sign a voluntary written informed consent Able and willing to attend scheduled follow-up visits and study related exams Exclusion Criteria: Greater than 30% reduction in wound size (DFU) or 20% reduction in VLU during first week of observation by the investigator Ulcer with exposed tendon or bone Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis Ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers) Known severe anemia Known serum albumin < 2.5 Renal failure requiring dialysis Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV Severe liver disease as defined by the treating physician or patient's primary care physician Malignancy at or near the ulcer site Any condition judged by the investigator that would cause the study to be detrimental to the patient Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator Received another investigational device or drug within 30 days of Day 0. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment Received another allograft, autograft or xenograft within 30 days of the Day 0/ Known allergy to equine derived tissue Alcohol or drug abuse, defined as current medical treatment for substance abuse Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Population<br>Study population are subjects at least 18 years old and of any ethnic background with a full thickness diabetic foot ulcer or venous leg ulcer, where the ulcer has been diagnosed/present for greater than 4 weeks duration. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete wound closure | Time to complete wound closure and percent wounds healed at 12 weeks | Weekly assessment up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Wound Closure | Mean and median wound size changes at 4, 6, 12 & 24 weeks, along with ulcer recurrence and/or device related adverse events. | 4, 6, 12 & 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)