Diabetic Foot Ulcer Research Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2027-01-01

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.

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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.

Conditions

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Diabetic Foot Ulcer Diabetic Foot Ulcer Neuropathic Diabetic Foot Ulcer Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Combination of normal standard of care and study device

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Subjects will be randomised 1:1 to RTD Wound Dressing or standard of care dressing. Randomisation will be in blocks of four.

Study Groups

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Study Device

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.

Group Type EXPERIMENTAL

Wound Dressing

Intervention Type DEVICE

RTD Wound Dressing that is being investigated

Standard of Care

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

Group Type ACTIVE_COMPARATOR

NHS Standard Dressing

Intervention Type DEVICE

This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer

Interventions

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Wound Dressing

RTD Wound Dressing that is being investigated

Intervention Type DEVICE

NHS Standard Dressing

This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No