Diabetic Foot Ulcer Research Study

Community Pharmacology Services Ltd

Status: Enrolling

Conditions: Diabetic Foot Ulcer Ischemic; Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer

Treatments: Device: NHS Standard Dressing; Device: Wound Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05762432

CPS22.007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Study Device

Experimental group

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.

Treatment:

Device: Wound Dressing

Standard of Care

Active Comparator group

Description:

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

Treatment:

Device: NHS Standard Dressing