UnknownNot Applicable

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

20 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Time to complete wound closure

Timeframe: Weekly assessment up to 12 weeks

Trial details

NCT IDNCT02309684

SponsorMLM Biologics Inc.,

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-06

Contact for this trial

Elmer Croushore, MD

352-538-3180

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