Diabetic Foot Ulcer Research Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Wound Dressing
* Device: NHS Standard Dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Combination of normal standard of care and study device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Device<br>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. | Device: Wound Dressing<br>* RTD Wound Dressing that is being investigated<br>|
| Active Comparator: Standard of Care<br>This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics. | Device: NHS Standard Dressing<br>* This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Wound Healing | 100% epithelialised | 12 weeks | 
| Reduction in Wound Area | % reduction in size of Wound Area | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Infection Rates | Rates at which the wound is infected | 12 weeks | 
| Dressing Changes | Number of dressing changes required per week and in total | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Foot Ulcer, Diabetic Foot Ulcer