Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Spiracur, Inc..
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
First received: August 12, 2011
Last updated: December 11, 2012
Last verified: December 2012
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.
Lower Extremity Diabetic Leg Wounds
Lower Extremity Venous Leg Wounds
Lower Extremity Mixed Aetiology Leg Wounds
Device: SNaP® Wound Care System
||Observational Model: Cohort
Time Perspective: Prospective
||Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
Primary Outcome Measures:
- Wound Closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
SNaP® Wound Care System
Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417208
|Section of Wound Healing
|Cardiff, Wales, United Kingdom, CF14 4XN |
No publications provided
ClinicalTrials.gov processed this record on September 03, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 12, 2011
||December 11, 2012
||United Kingdom: National Health Service
United Kingdom: Research Ethics Committee