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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spiracur, Inc.
ClinicalTrials.gov Identifier:
NCT01417208
First received: August 12, 2011
Last updated: December 11, 2012
Last verified: December 2012
  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

Further study details as provided by Spiracur, Inc.:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417208

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

No publications provided

Responsible Party: Spiracur, Inc.
ClinicalTrials.gov Identifier: NCT01417208     History of Changes
Other Study ID Numbers: 011711
Study First Received: August 12, 2011
Last Updated: December 11, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 22, 2014