Back to resultsDiabetic 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
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetes, Foot Ulcer, Diabetic Foot Ulcer
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.
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
NCT ID
NCT05762432
First Posted
February 17, 2023
Last Updated
August 29, 2023
Sponsor
Community Pharmacology Services Ltd
Collaborators
Keneric Healthcare
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
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