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Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.

Primary Purpose

Diabetes Mellitus Foot Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DiaSole
Sponsored by
Kaydiar Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Foot Ulcer

Eligibility Criteria

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

Inclusion Criteria: Age 18 years and above Capacity to consent UK Shoe size 3-11 Diagnosis of Diabetes Sensory neuropathy (lack of perception of 10g monofilament in one or more sites of the feet) Active foot ulceration (plantar aspect), grade 1a using the University of Texas wound grading system (grade 1a) Appropriate footwear (which has room to safely accommodate the DiaSole insole) At risk of ulceration or re-ulceration (Grade 0A) Exclusion Criteria: Patients who are non-concordant and do not have appropriate footwear that could house the DiaSole insole Clinical signs of or confirmed active infection (soft tissue or osteomyelitis) History of or active Charcot foot or severe foot deformity Amputation Critical limb ischemia or diagnosed moderate to severe peripheral arterial disease Inappropriate footwear (does not accommodate the DiaSole insole) Visual impairment (cannot see feet and footwear properly) Sensory neuropathy of the upper limbs/hands History of drug and alcohol abuse• Have known contraindications to the materials used in the product insoles. Allergies to cotton or silicone Have an infectious disease, which may pose as a potential risk to the researchers and clinicians Are enrolled into another study Unable to attend regular hospital visits - e.g. housebound Are unwilling to take part in the study Are currently enrolled in any other research Individuals who do not adequately understand verbal explanations of written information in English, unless there is access to a qualified translator Are not suitable for the evaluation, according to the podiatrist's or nurse's clinical judgement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Main study

    Arm Description

    Study to investigate the safety and clinical efficacy of the DiaSole insole.

    Outcomes

    Primary Outcome Measures

    Assessing the safety of the DiaSole insole
    Recording adverse events

    Secondary Outcome Measures

    Clinical efficacy of DiaSole insole
    Assessing wound closure area (mm2)
    acceptability of DiaSole to health care professionals (HCPs)
    Survey based feedback from HCPs

    Full Information

    First Posted
    October 28, 2022
    Last Updated
    October 28, 2022
    Sponsor
    Kaydiar Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05604352
    Brief Title
    Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.
    Official Title
    Extended Phase 2 Product Evaluation Single Sample Study - To Evaluate the Safety of the DiaSole Insole for Use on Patients With Diabetic Foot Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    April 28, 2023 (Anticipated)
    Study Completion Date
    May 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaydiar Ltd

    4. Oversight

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

    5. Study Description

    Brief Summary
    Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions. It may be possible to use the DiaSole for other causes of neuropathic foot ulcerations (such as rheumatoid arthritis), but the safety of the insole needs assessing first. There is already evidence to support the use of offloading insoles in the healing and prevention of pressure ulcers, DiaSole may be an improved insole for this purpose.
    Detailed Description
    DiaSole is an insole developed to aid the treatment of diabetic foot ulcers through offloading. Offloading (reducing pressure) plays an integral role in the treatment of diabetic ulcers. DiaSole is modular in construction comprising of many 'cells', which can be individually removed to create the offloading cavity. This study aims to evaluate the safety of DiaSole with diabetic patients who have superficial ulcers. The ulcer severity of patients included will not involve tendon, capsule or bone, or will be pre or post ulceration and have healed skin integrity (Texas wound classification 1A and 0A respectively). The study will be conducted within Hywel Dda University Health Board (HDUHB) Podiatry services. Participants will be seen in clinic by the podiatrists emplyed within HDUHB. The patients who consent to take part will be issued a DiaSole insole as part of their usual care and under guidance of the podiatrist. The participants will be instructed to use the DiaSole as part of their ulcer offloading, for an 8-week period. The primary outcome of this study is to assess the safety of the DiaSole insole with patients who have diabetic neuropathy and are at risk of a pressure ulcer in the feet and/or who have a superficial pressure ulcer. All adverse events and serious adverse events will be documented and used to assess the safety of DiaSole. During the 8-week period the participants will have photographs taken of their pressure ulcer sites so that any changes to its size can be monitored. The depth of the ulcer will also be measured using a probe. The ulcer dimensions will be monitored as a secondary outcome and data will be collected during the first appointment, then again at weeks 1,2,3,4 and then week 8. An evaluation form will also be used to capture clinician and patient feedback regarding acceptability at week 8.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single sample, no randomisation, no blinding.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Main study
    Arm Type
    Experimental
    Arm Description
    Study to investigate the safety and clinical efficacy of the DiaSole insole.
    Intervention Type
    Device
    Intervention Name(s)
    DiaSole
    Intervention Description
    Diabetic ulcer offloading insole
    Primary Outcome Measure Information:
    Title
    Assessing the safety of the DiaSole insole
    Description
    Recording adverse events
    Time Frame
    8-weeks per patient
    Secondary Outcome Measure Information:
    Title
    Clinical efficacy of DiaSole insole
    Description
    Assessing wound closure area (mm2)
    Time Frame
    8-weeks per patient
    Title
    acceptability of DiaSole to health care professionals (HCPs)
    Description
    Survey based feedback from HCPs
    Time Frame
    8-weeks per patient

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years and above Capacity to consent UK Shoe size 3-11 Diagnosis of Diabetes Sensory neuropathy (lack of perception of 10g monofilament in one or more sites of the feet) Active foot ulceration (plantar aspect), grade 1a using the University of Texas wound grading system (grade 1a) Appropriate footwear (which has room to safely accommodate the DiaSole insole) At risk of ulceration or re-ulceration (Grade 0A) Exclusion Criteria: Patients who are non-concordant and do not have appropriate footwear that could house the DiaSole insole Clinical signs of or confirmed active infection (soft tissue or osteomyelitis) History of or active Charcot foot or severe foot deformity Amputation Critical limb ischemia or diagnosed moderate to severe peripheral arterial disease Inappropriate footwear (does not accommodate the DiaSole insole) Visual impairment (cannot see feet and footwear properly) Sensory neuropathy of the upper limbs/hands History of drug and alcohol abuse• Have known contraindications to the materials used in the product insoles. Allergies to cotton or silicone Have an infectious disease, which may pose as a potential risk to the researchers and clinicians Are enrolled into another study Unable to attend regular hospital visits - e.g. housebound Are unwilling to take part in the study Are currently enrolled in any other research Individuals who do not adequately understand verbal explanations of written information in English, unless there is access to a qualified translator Are not suitable for the evaluation, according to the podiatrist's or nurse's clinical judgement
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David J Barton, BSc(hons)
    Phone
    07552140218
    Email
    david@kaydiar.co.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heather M Smart, BSc(hons)
    Phone
    07548676623
    Email
    heathermairesmart@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No patient identifiable information will be shared outside of the direct care team or the research team.

    Learn more about this trial

    Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.

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