WoundsNCT02458859
Trial of PICO Versus Standard Care in Chronic and Sub-acute Wounds
A study testing PICO (single use portable negative pressure wound therapy) in people with Wounds, run by Smith & Nephew, Inc. at 20 sites in 2 countries.
Trial summary
Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to investigate Time to healing, health economic and patient reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- PICO (single use portable negative pressure wound therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Mar 2012to Jun 2015
- Phase
- Interventional
- 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
Who may be able to join
- Patients >18 years old
- Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided.
- The patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial.
- Patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a PICO dressing.
- Wound duration ≤52 weeks - Amended to remove criteria.
- Wound area range ≥5 cm2 at start of screening period
- Wound maximum linear dimension ≤ 15cm
- Able to use English for the interview
Who cannot join
- Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
- Wounds which have an infection which is not being treated with systemic antibiotics.
- Wounds which are actively bleeding.
- Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
- Exclude undermining or tunnelling present or suspected in the wound
- Use of negative pressure device on wound in the last 30 days. Amended to remove criteria
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- Malignant wounds/malignancy in the wound
- Systemic infection not being treated with systemic antibiotics
- Simultaneous treatment with other experimental wound care procedures, biologics or devices
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this trial previously and who closed or were withdrawn.
- Patients who are unable to understand the aims and objectives of the trial.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United Kingdom19 sites
Bradford District Care Trust
Bradford
Papworth Surgery
Cambridge
Cossington House Surgery
Canterbury
Richmond House Surgery
Crook of Devon
Barton Surgery
Dawlish
Derby Hospit6al NHS Foundation Trust
Derby
South Axholme Practice
Doncaster
Sea Road Surgery
Garway
Dr Moss & Partners
Harrogate
The Honiton Group Practise
Honiton
Leodis Care Limited
Leeds, LS17 7PE
Barlow Medical centre
Manchester
Wellfield Medical Centrre
Manchester
Southbourne Surgery
Milton of Campsie
Kiltearn Medical Centre
Nantwich
Northumbria Healthcare NHS Trust
Newcastle
South Tyneside NHS Foundation Trust
Newcastle
Dr Jones & Partners
Sedgefield
Brunel Medical practise
Torquay
About this study
Official title: A 100 Patient, Prospective, Randomised, Clinical Evaluation Comparing Clinical and Health Economic Outcomes Between Patients With Chronic or Sub-acute Wounds Treated With Either PICO or Standard Care Dressings and a Qualitative Study to Explore the Experiences of Patients Receiving PICO With Particular Emphasis on Concordance
Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to investigate Time to healing, health economic and patient reported outcomes.
Read the detailed description
The current study is being conducted to assess the clinical and cost effectiveness of managing patients with a chronic or sub-acute wound in a community setting with PICO and to explore the patient experience and issues of concordance that affect patients treated with PICO. The study will provide information on the level of clinical benefit that PICO can deliver in the population studied in order to justify a sample size for a definitive evaluation of PICO and the study will further assess wound types that may benefit from treatment with PICO.
- Conditions
- Wounds
- Being tested
- PICO (single use portable negative pressure wound therapy)
- Keywords
- Chronic, Subacute
- Medical subject headings
- Wounds and Injuries, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO (single use portable negative pressure wound therapy)Device
Single use portable negative pressure wound therapy
| Study group | Role | What they receive |
|---|---|---|
| PICO | Active comparator | PICO Negative Pressure Wound Therapy (NPWT) system Receives: Device: PICO (single use portable negative pressure wound therapy) |
| Standard care | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to closure
Time to complete 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 posted1 Jun 2015 (estimated)
- Study startMar 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Moffatt, Prof, Principal investigator, Royal Derby Hospitals NHS Foundation trust/Nottingham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458859
- Sponsor's protocol ID
- CE/044/PIC
- Status last verified
- Feb 2018
- First submitted
- 18 Aug 2011
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 100 Patient, Prospective, Randomised, Clinical Evaluation Comparing Clinical and Health Economic Outcomes Between Patients With Chronic or Sub-acute Wounds Treated With Either PICO or Standard Care Dressings and a Qualitative Study to Explore the Experiences of Patients Receiving PICO With Particular Emphasis on Concordance
- ClinicalTrials.gov ID
- NCT02458859
- Acronym / sponsor ID
- CE/044/PIC
- Conditions
- Wounds
- Keywords
- Chronic, Subacute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Jun 2015 (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.
Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to investigate Time to healing, health economic and patient reported outcomes.
Detailed description
The current study is being conducted to assess the clinical and cost effectiveness of managing patients with a chronic or sub-acute wound in a community setting with PICO and to explore the patient experience and issues of concordance that affect patients treated with PICO. The study will provide information on the level of clinical benefit that PICO can deliver in the population studied in order to justify a sample size for a definitive evaluation of PICO and the study will further assess wound types that may benefit from treatment with PICO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO | Active comparator | Device: PICO (single use portable negative pressure wound therapy)PICO Negative Pressure Wound Therapy (NPWT) system |
| Standard care | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients >18 years old
- Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided.
- The patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial.
- Patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a PICO dressing.
- Wound duration ≤52 weeks - Amended to remove criteria.
Key exclusion criteria (12 listed)
- Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
- Wounds which have an infection which is not being treated with systemic antibiotics.
- Wounds which are actively bleeding.
- Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
- Exclude undermining or tunnelling present or suspected in the wound
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 |
|---|---|---|
| PICO (single use portable negative pressure wound therapy)Single use portable negative pressure wound therapy | Device | PICO |
Primary outcome
Time to closure
Time frame: 12 weeks
Time to complete wound closure
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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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.
Christine Moffatt, Prof principal investigator
Royal Derby Hospitals NHS Foundation trust/Nottingham University
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO (single use portable negative pressure wound therapy) in people with Wounds, run by Smith & Nephew, Inc. at 20 sites in 2 countries.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, Canada. 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 stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
Time to 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 13 Feb 2018.