Lower Extremity Diabetic Leg WoundsNCT01417208
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
An observational study of Lower Extremity Diabetic Leg Wounds and Lower Extremity Venous Leg Wounds, run by KCI USA, Inc at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds, Lower Extremity Mixed Aetiology Leg Wounds
- What is being tested?
- SNaP® Wound Care System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SNaP® Wound Care System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNaP® Wound Care SystemDevice
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
| Study group | Role | What they receive |
|---|---|---|
| SNaP® Wound Care System | Not described Receives: Device: SNaP® Wound Care System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: The study was terminated by Spiraur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Diabetic Leg WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417208
- Sponsor's protocol ID
- 011711
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2011
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
- ClinicalTrials.gov ID
- NCT01417208
- Acronym / sponsor ID
- 011711
- Conditions
- Lower Extremity Diabetic Leg Wounds, Lower Extremity Venous Leg Wounds, Lower Extremity Mixed Aetiology Leg Wounds
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was terminated by Spiraur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNaP® Wound Care System | – | Device: SNaP® Wound Care System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNaP® Wound Care SystemWound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. | Device | SNaP® Wound Care System |
Primary outcome
Wound Closure
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Extremity Diabetic Leg Wounds and Lower Extremity Venous Leg Wounds, run by KCI USA, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.