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Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Spiracur, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417208
First Posted: August 16, 2011
Last Update Posted: December 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Spiracur, Inc.
  Purpose
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.

Condition Intervention
Lower Extremity Diabetic Leg Wounds Lower Extremity Venous Leg Wounds Lower Extremity Mixed Aetiology Leg Wounds Device: SNaP® Wound Care System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds

Resource links provided by NLM:


Further study details as provided by Spiracur, Inc.:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: 12 weeks ]

Estimated Enrollment: 45
Study Start Date: June 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SNaP® Wound Care System Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetic foot ulceration, venous or mixed aetiology lower limb ulceration who are receiving out-patient treatment from the Section of Wound Healing, Cardiff University, Wales.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417208


Locations
United Kingdom
Section of Wound Healing
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Spiracur, Inc.
  More Information

Responsible Party: Spiracur, Inc.
ClinicalTrials.gov Identifier: NCT01417208     History of Changes
Other Study ID Numbers: 011711
First Submitted: August 12, 2011
First Posted: August 16, 2011
Last Update Posted: December 12, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Wounds and Injuries