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Prevention Of Primary Foot Ulcers in High-risk Diabetes Patients (PROFOUND)

Primary Purpose

Diabetes Mellitus, Foot Ulcer, Diabetic, Primary Prevention

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D printed insoles for normal footware
Sponsored by
Countess of Chester NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of diabetes (type 1 or 2)
  • Aged ≥18
  • Peripheral sensory neuropathy assessed by 10-gram monofilament With
  • Signs of abnormal loading as indicated by callus formation or hyperaemia Or
  • limb ischaemia as evidenced by intermittent claudication /non-palpable pulses / history of vascular intervention Or
  • on renal replacement therapy

Exclusion Criteria:

  • Patients currently prescribed with or in need of therapeutic footwear
  • Active or history of foot ulcer
  • Active Charcot's neuroarthropathy
  • History of major operation in the foot including amputation,
  • Local / systemic symptoms of infection, severe illness that would make 12 month survival unlikely
  • Unable to provide informed consent
  • Inability to follow the study instructions (as judged by the recruiting clinician).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention arm

    Control

    Arm Description

    6 sites out of a total of 12 will act as the intervention sites. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to be provided with bespoke 3-D printed insoles.

    6 sites out of a total of 12 will act as the control sites providing standard care. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to standard care

    Outcomes

    Primary Outcome Measures

    The incidence of new ulcer in patients with high-risk diabetic feet is our primary outcome measure
    Ulcer is defined as any new break in the skin of the feet

    Secondary Outcome Measures

    To compare patient satisfaction at baseline 26, and 52 weeks post randomisation
    standardised questionnaires
    To evaluate quality of life using NeuroQoL at baseline, 26, and 52 weeks post randomisation
    standardised questionnaires
    Incidence of adverse events relating in the 3D insole group over 52 weeks post randomisation
    AE event recording
    New callus formation
    Clinical examination by podiatrists
    To evaluate quality of life using EQ-5D-3L at baseline, 26, and 52 weeks post randomisation
    standardised questionnaires
    Need for debridement of callus
    Clinical examination by podiatrists

    Full Information

    First Posted
    May 15, 2019
    Last Updated
    May 19, 2019
    Sponsor
    Countess of Chester NHS Foundation Trust
    Collaborators
    University of Liverpool, Staffordshire University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03958539
    Brief Title
    Prevention Of Primary Foot Ulcers in High-risk Diabetes Patients
    Acronym
    PROFOUND
    Official Title
    Prevention Of Primary Foot Ulcers in High-risk Diabetes Patients (PrOFoUnD): A Cluster Randomised Trial of 3D Printed Insoles Versus Standard Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 5, 2019 (Anticipated)
    Primary Completion Date
    February 1, 2021 (Anticipated)
    Study Completion Date
    February 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Countess of Chester NHS Foundation Trust
    Collaborators
    University of Liverpool, Staffordshire University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a primary prevention study which aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care
    Detailed Description
    Once a patient with diabetes develops a foot ulcer 80% are likely to have a lower limb amputation in the future. Amputation carries a considerable burden of cost and impaired quality of life (QOL) and is associated with a 5-year mortality rate of 70%. Once a patient develops an ulcer they remain at high risk for life and are likely to suffer considerable morbidity, debilitation, reduced quality of life and numerous attendances with health care professionals including emergency hospital presentation. There are significant costs associated with the management of diabetes foot ulcers (DFU) which accounts for £1 billion of NHS funding and an average weekly care cost of £208 per person. Both diabetes ulcers and amputation for the most part are preventable providing that patients have effective glycaemic control, regular foot assessments, care for their feet appropriately and wear appropriate footwear or orthotic wear to prevent ulceration. The focus of this initiative is to utilise digital capability by 3D scanning systems in the community for the provision of highly cost-effective 3D printed soles for shoes which distribute the pressure on the feet whilst having the flexibility of being used in general footwear, thus improving compliance. The cost of these soles is very low at approximately £40 for two pairs. More complex orthotics cost on average £525 each. Scanners and software are likely to be offered free if this is scaled up. The investigators are proposing to work closely with podiatrists in local foot protection services to assess a number of patients at high risk of foot ulcer and deliver a care bundle, which will include assessment, education around both foot care and promoting structured education and 3D sole provision. The study aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care. The secondary outcome measures will be improvement in standardised QOL measures. 450 diabetes patients with high-risk feet would be recruited who would be prepared to wear the custom made 3D printed insoles on a regular basis (Intervention group). The control group will be formed of 450 diabetes patients with high-risk feet who will receive standard care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Foot Ulcer, Diabetic, Primary Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    As this study involves a complex intervention in the form of a pathway, we chose a cluster randomisation design to mitigate the risk of contamination across the groups. The podiatry units will find it much easier to follow one pathway for all participants in their sites. We also reduce the cost by halving the number of foot scanners required to be purchased (and the staff training required) for the study by using cluster randomisation.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    900 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention arm
    Arm Type
    Active Comparator
    Arm Description
    6 sites out of a total of 12 will act as the intervention sites. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to be provided with bespoke 3-D printed insoles.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    6 sites out of a total of 12 will act as the control sites providing standard care. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to standard care
    Intervention Type
    Device
    Intervention Name(s)
    3D printed insoles for normal footware
    Intervention Description
    Imprints are low-cost, bespoke, 3D-printed orthotics designed to prevent diabetic foot ulceration by redistributing and lowering peak foot pressures. This is achieved by using different density zones designed specifically for the patient. The patient's foot shape and pressure zone are capture by a 3D imaging system. Once scanned the software automatically identifies the peak pressure zones, matches these with the correct material and stiffness (densities), fits the insole arch to the patient and generates the insole. The imprints insole is divided into four pressure zones: heel, midfoot, metatarsal head region and toes. These zones are printed with different stiffness to account for the difference in loading between them. The design of the pressure zones is automatically matched to the shape of each individual foot with the help of the 3D scan.
    Primary Outcome Measure Information:
    Title
    The incidence of new ulcer in patients with high-risk diabetic feet is our primary outcome measure
    Description
    Ulcer is defined as any new break in the skin of the feet
    Time Frame
    Within 1 year of randomisation
    Secondary Outcome Measure Information:
    Title
    To compare patient satisfaction at baseline 26, and 52 weeks post randomisation
    Description
    standardised questionnaires
    Time Frame
    Within 1 year of randomisation
    Title
    To evaluate quality of life using NeuroQoL at baseline, 26, and 52 weeks post randomisation
    Description
    standardised questionnaires
    Time Frame
    Within 1 year of randomisation
    Title
    Incidence of adverse events relating in the 3D insole group over 52 weeks post randomisation
    Description
    AE event recording
    Time Frame
    Within 1 year of randomisation
    Title
    New callus formation
    Description
    Clinical examination by podiatrists
    Time Frame
    Within 1 year of randomisation
    Title
    To evaluate quality of life using EQ-5D-3L at baseline, 26, and 52 weeks post randomisation
    Description
    standardised questionnaires
    Time Frame
    Within 1 year of randomisation
    Title
    Need for debridement of callus
    Description
    Clinical examination by podiatrists
    Time Frame
    Within 1 year of randomisation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of diabetes (type 1 or 2) Aged ≥18 Peripheral sensory neuropathy assessed by 10-gram monofilament With Signs of abnormal loading as indicated by callus formation or hyperaemia Or limb ischaemia as evidenced by intermittent claudication /non-palpable pulses / history of vascular intervention Or on renal replacement therapy Exclusion Criteria: Patients currently prescribed with or in need of therapeutic footwear Active or history of foot ulcer Active Charcot's neuroarthropathy History of major operation in the foot including amputation, Local / systemic symptoms of infection, severe illness that would make 12 month survival unlikely Unable to provide informed consent Inability to follow the study instructions (as judged by the recruiting clinician).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul McKenzie, PhD
    Phone
    07730 376246
    Email
    paul.mackenzie@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sunil Nair, FRCP, PhD
    Organizational Affiliation
    Countess of Chester Hospital NHS Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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