Study Stopped
Poor recruitment
Trial of PICO Versus Standard Care in Chronic and Sub-acute Wounds
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
1 other identifier
interventional
62
2 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 13, 2018
February 1, 2018
3.3 years
August 18, 2011
February 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to closure
Time to complete wound closure
12 weeks
Study Arms (2)
PICO
ACTIVE COMPARATORPICO Negative Pressure Wound Therapy (NPWT) system
Standard care
NO INTERVENTIONStandard care
Interventions
Single use portable negative pressure wound therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Nursing Practise Solutions
Altario, Canada
Bradford District Care Trust
Bradford, United Kingdom
Papworth Surgery
Cambridge, United Kingdom
Cossington House Surgery
Canterbury, United Kingdom
Richmond House Surgery
Crook of Devon, United Kingdom
Barton Surgery
Dawlish, United Kingdom
Derby Hospit6al NHS Foundation Trust
Derby, United Kingdom
South Axholme Practice
Doncaster, United Kingdom
Sea Road Surgery
Garway, United Kingdom
Dr Moss & Partners
Harrogate, United Kingdom
The Honiton Group Practise
Honiton, United Kingdom
Leodis Care Limited
Leeds, LS17 7PE, United Kingdom
Barlow Medical centre
Manchester, United Kingdom
Wellfield Medical Centrre
Manchester, United Kingdom
Southbourne Surgery
Milton of Campsie, United Kingdom
Kiltearn Medical Centre
Nantwich, United Kingdom
Northumbria Healthcare NHS Trust
Newcastle, United Kingdom
South Tyneside NHS Foundation Trust
Newcastle, United Kingdom
Dr Jones & Partners
Sedgefield, United Kingdom
Brunel Medical practise
Torquay, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Moffatt, Prof
Royal Derby Hospitals NHS Foundation trust/Nottingham University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2011
First Posted
June 1, 2015
Study Start
March 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 13, 2018
Record last verified: 2018-02