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

Skin Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02309684
• Other study ID #: MLM1301
• Status: Not yet recruiting
• Phase: N/A
• First received: December 3, 2014
• Last updated: December 4, 2014
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2014
• Source: MLM Biologics Inc.,
• Contact: Elmer Croushore, MD
• Phone: 352-538-3180
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Skin Ulcer
• Ulcer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MLM Biologics Inc.,

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete wound closure	Time to complete wound closure and percent wounds healed at 12 weeks	Weekly assessment up to 12 weeks	No
Secondary	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	Yes