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

NCT01417208 | Withdrawn

• 1 other identifier: 011711
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Diabetic Leg Wounds; Lower Extremity Venous Leg Wounds; Lower Extremity Mixed Aetiology Leg Wounds

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  12 weeks

Study Arms (1)

SNaP® Wound Care System

Device: SNaP® Wound Care System

Interventions

SNaP® Wound Care System DEVICE

Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

SNaP® Wound Care System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KCI USA, Inc: lead
• 3M: collaborator

Study Sites (1)

Section of Wound Healing

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 16, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

GB (1)