Skin Ulcer
Conditions
Keywords
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
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.
Interventions
None listed
Sponsors
MLM Biologics Inc.,
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. The ulcer has been diagnosed/present for greater than 4 weeks duration. 3. Three or fewer ulcers separated by \> 3.0 cm distance 4. Post-debridement, the ulcer size must be \> 5 sq cm 5. Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present: 1. transcutaneous partial pressure oxygen (TcPO2) \> 30 mmHg at the ankle 2. toe pressure of \>40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) 6. At least 18 years old 7. Able and willing to read and sign a voluntary written informed consent 8. Able and willing to attend scheduled follow-up visits and study related exams
Exclusion criteria
1. Greater than 30% reduction in wound size (DFU) or 20% reduction in VLU during first week of observation by the investigator 2. Ulcer with exposed tendon or bone 3. Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis 4. Ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers) 5. Known severe anemia 6. Known serum albumin \< 2.5 7. Renal failure requiring dialysis 8. Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV 9. Severe liver disease as defined by the treating physician or patient's primary care physician 10. Malignancy at or near the ulcer site 11. Any condition judged by the investigator that would cause the study to be detrimental to the patient 12. 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 13. Received another investigational device or drug within 30 days of Day 0. 14. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment 15. Received another allograft, autograft or xenograft within 30 days of the Day 0/ 16. Known allergy to equine derived tissue 17. Alcohol or drug abuse, defined as current medical treatment for substance abuse 18. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound closure | Weekly assessment up to 12 weeks | Time to complete wound closure and percent wounds healed at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactElmer Croushore, MD
Backup ContactChandra Nataraj, PhD
Outcome results
None listed