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

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.
 
ClinicalTrials.gov Identifier: NCT01417208
Recruitment Status : Withdrawn (The study was terminated by Spiraur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.)
First Posted : August 16, 2011
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

Tracking Information
First Submitted Date August 12, 2011
First Posted Date August 16, 2011
Last Update Posted Date September 7, 2020
Actual Study Start Date June 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2012)
Wound Closure [ Time Frame: 12 weeks ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
Official Title Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Lower Extremity Diabetic Leg Wounds
  • Lower Extremity Venous Leg Wounds
  • Lower Extremity Mixed Aetiology Leg Wounds
Intervention Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Study Groups/Cohorts SNaP® Wound Care System
Intervention: Device: SNaP® Wound Care System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: September 3, 2020)
0
Original Estimated Enrollment
 (submitted: August 15, 2011)
45
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01417208
Other Study ID Numbers 011711
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party KCI USA, Inc.
Study Sponsor KCI USA, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account KCI USA, Inc.
Verification Date September 2020