Overview

This trial is active, not recruiting.

Conditions lower extremity diabetic leg wounds, lower extremity venous leg wounds, lower extremity mixed aetiology leg wounds
Treatment snap® wound care system
Sponsor Spiracur, Inc.
Start date June 2011
End date December 2012
Trial size 45 participants
Trial identifier NCT01417208, 011711

Summary

The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
snap® wound care system
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Primary Outcomes

Measure
Wound Closure
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease). - Wound present for >30 days. - Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings. - Patient is able to comply with study protocol requirements. - Patient is able to understand and provide written consent. Exclusion Criteria: - Patient has evidence of wound infection in the opinion of the physician. - Patient has a thick eschar that persists after wound debridement. - Patient has an HbA1C >12%. - Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis. - Patient has untreated osteomyelitis. - Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study. - Patient is allergic to the wound care device or occlusive dressing. - Patient has exposed blood vessels. - Patient is pregnant or pregnancy is suspected. - Patient is actively participating in other clinical trials that may interfere with their participation in this study.

Additional Information

Official title Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Spiracur, Inc..