search
Back to results

Diabetic Foot Ulcer Research Study

Primary Purpose

Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer Ischemic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wound Dressing
NHS Standard Dressing
Sponsored by
Community Pharmacology Services Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetes, Foot Ulcer, Diabetic Foot Ulcer

Eligibility Criteria

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

Inclusion Criteria: Male or female, aged ≥18 years old with a diagnosis of type 1 or type 2 diabetes. New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non- infected DFU Subjects must be able to follow verbal and written instructions in English Subjects must have full mental capacity and able to give written informed consent to participation in the trial including medical photography for the purposes of the clinical trial or clinical care. DFU is >10mm2 and <100mm2 Exclusion Criteria: Known allergy/hypersensitivity to any ingredient contained in the Keneric healthcare RTD Wound Dressing Participants who will have problems following the protocol, including the offloading system, provided as standard of care, to wear on a daily basis Suspected malignancy in the wound Critical limb ischaemia Pregnant or breastfeeding females Women of childbearing potential and not using a medically accepted form of contraception when sexually active.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Study Device

    Standard of Care

    Arm Description

    This Arm of the study will receive the study device. Although the Study Device is not experimental as it is already CE marked and being used for it's intended purpose.

    This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics.

    Outcomes

    Primary Outcome Measures

    Completion of Wound Healing
    100% epithelialised
    Reduction in Wound Area
    % reduction in size of Wound Area

    Secondary Outcome Measures

    Wound Infection Rates
    Rates at which the wound is infected
    Dressing Changes
    Number of dressing changes required per week and in total

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Community Pharmacology Services Ltd
    Collaborators
    Keneric Healthcare
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05762432
    Brief Title
    Diabetic Foot Ulcer Research Study
    Official Title
    A Pilot Open Label Prospective, Randomised, Study to Evaluate the Safety and Efficacy of Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Community Pharmacology Services Ltd
    Collaborators
    Keneric Healthcare

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device. The main outcomes it aims to achieve are: Complete wound healing at 12 weeks (100% epithelialised) % Reduction in wound area at 12 weeks Participants will attend their NHS podiatry clinic appointment as normal and will be assigned either the study device or the current typical NHS standard of care device. Researchers will compare the study device group to the standard group to assess the outcomes mentioned previously.
    Detailed Description
    The purpose of this clinical trial is to evaluate the safety and performance of the RTD Wound Dressing in the treatment of non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers versus standard of care. This clinical evaluation study will be performed under an open-label, comparative, design in the single health board of NHS Lanarkshire within 3 diabetic foot clinics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer Ischemic
    Keywords
    Diabetes, Foot Ulcer, Diabetic Foot Ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Combination of normal standard of care and study device
    Masking
    None (Open Label)
    Masking Description
    Subjects will be randomised 1:1 to RTD Wound Dressing or standard of care dressing. Randomisation will be in blocks of four.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Device
    Arm Type
    Experimental
    Arm Description
    This Arm of the study will receive the study device. Although the Study Device is not experimental as it is already CE marked and being used for it's intended purpose.
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics.
    Intervention Type
    Device
    Intervention Name(s)
    Wound Dressing
    Intervention Description
    RTD Wound Dressing that is being investigated
    Intervention Type
    Device
    Intervention Name(s)
    NHS Standard Dressing
    Intervention Description
    This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer
    Primary Outcome Measure Information:
    Title
    Completion of Wound Healing
    Description
    100% epithelialised
    Time Frame
    12 weeks
    Title
    Reduction in Wound Area
    Description
    % reduction in size of Wound Area
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Wound Infection Rates
    Description
    Rates at which the wound is infected
    Time Frame
    12 weeks
    Title
    Dressing Changes
    Description
    Number of dressing changes required per week and in total
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, aged ≥18 years old with a diagnosis of type 1 or type 2 diabetes. New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non- infected DFU Subjects must be able to follow verbal and written instructions in English Subjects must have full mental capacity and able to give written informed consent to participation in the trial including medical photography for the purposes of the clinical trial or clinical care. DFU is >10mm2 and <100mm2 Exclusion Criteria: Known allergy/hypersensitivity to any ingredient contained in the Keneric healthcare RTD Wound Dressing Participants who will have problems following the protocol, including the offloading system, provided as standard of care, to wear on a daily basis Suspected malignancy in the wound Critical limb ischaemia Pregnant or breastfeeding females Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Duncan Stang, MChS
    Phone
    07554333493
    Email
    duncan.stang@lanarkshire.scot.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kaye McIntyre, MsC
    Phone
    01236 748748
    Email
    Kaye.McIntyre@lanarkshire.scot.nhs.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kaye McIntyre, MsC
    Organizational Affiliation
    NHS Lanarkshire
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No data will be shared.

    Learn more about this trial

    Diabetic Foot Ulcer Research Study

    We'll reach out to this number within 24 hrs