Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study Population 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. |
Outcome Measures
Primary Outcome Measures
- Time to complete wound closure [Weekly assessment up to 12 weeks]
Time to complete wound closure and percent wounds healed at 12 weeks
Secondary Outcome Measures
- Rate of Wound Closure [4, 6, 12 & 24 weeks]
Mean and median wound size changes at 4, 6, 12 & 24 weeks, along with ulcer recurrence and/or device related adverse events.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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The ulcer has been diagnosed/present for greater than 4 weeks duration.
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Three or fewer ulcers separated by > 3.0 cm distance
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Post-debridement, the ulcer size must be > 5 sq cm
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Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present:
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transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle
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toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
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At least 18 years old
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Able and willing to read and sign a voluntary written informed consent
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Able and willing to attend scheduled follow-up visits and study related exams
Exclusion Criteria:
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Greater than 30% reduction in wound size (DFU) or 20% reduction in VLU during first week of observation by the investigator
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Ulcer with exposed tendon or bone
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Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
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Ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
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Known severe anemia
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Known serum albumin < 2.5
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Renal failure requiring dialysis
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Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
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Severe liver disease as defined by the treating physician or patient's primary care physician
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Malignancy at or near the ulcer site
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Any condition judged by the investigator that would cause the study to be detrimental to the patient
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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
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Received another investigational device or drug within 30 days of Day 0.
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Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment
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Received another allograft, autograft or xenograft within 30 days of the Day 0/
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Known allergy to equine derived tissue
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Alcohol or drug abuse, defined as current medical treatment for substance abuse
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Pregnant or nursing women
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- MLM Biologics Inc.,
Investigators
- Principal Investigator: Elmer Croushore, MD, NFRMC Wound Therapy Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MLM1301