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

NCT02309684 | Unknown

• 1 other identifier: MLM1301
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Ulcer

Keywords

Diabetic Foot Ulcer (DFU); Venous Leg Ulcer (VLU)

Outcome Measures

Primary Outcomes (1)

• Time to complete wound closure

  Time to complete wound closure and percent wounds healed at 12 weeks

  Weekly assessment up to 12 weeks

Secondary Outcomes (1)

• Rate of Wound Closure

  4, 6, 12 & 24 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 20 patients with DFU (n=10) and VLU (n=10) will be considered in this study if they sign the informed consent, and meet all inclusion criteria and none of the exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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/

Sponsors & Collaborators

• MLM Biologics Inc.,: lead

MeSH Terms

Conditions

Skin Ulcer; Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Elmer Croushore, MD

  NFRMC Wound Therapy Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elmer Croushore, MD

CONTACT

352-538-3180

Chandra Nataraj, PhD

CONTACT

352-514-4269; cnataraj@mlmbiologics.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: January 1, 2016
• Last Updated: December 5, 2014

Record last verified: 2014-12