Status:
UNKNOWN
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
Lead Sponsor:
MLM Biologics Inc.,
Conditions:
Skin Ulcer
Eligibility:
All Genders
18+ years
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02309684
Start Date
January 1 2015
End Date
January 1 2016
Last Update
December 5 2014
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