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

• Conditions: Skin Ulcer

• Registration Number: NCT02309684
• Lead Sponsor: MLM Biologics Inc.,

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-04
• Last Update Submitted: 2014-12-04
• Study First Posted: 2014-12-05
• Last Update Posted: 2014-12-05
• Study Start: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.