Diabetic Foot Ulcer Research Study

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer Ischemic
• Interventions: Device: Wound Dressing; Device: NHS Standard Dressing

• Registration Number: NCT05762432
• Lead Sponsor: Community Pharmacology Services Ltd

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.

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-09
• Status Verified: 2024-02
• Study Start: 2024-04-26
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study Device	Wound Dressing	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.
Standard of Care	NHS Standard Dressing	This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics.

Primary Outcome Measures

Name	Time	Method
Reduction in Wound Area	12 weeks	% reduction in size of Wound Area
Completion of Wound Healing	12 weeks	100% epithelialised

Secondary Outcome Measures

Name	Time	Method
Dressing Changes	12 weeks	Number of dressing changes required per week and in total
Wound Infection Rates	12 weeks	Rates at which the wound is infected

Trial Locations

Locations (2)

NHS Lothian; 🇬🇧 Livingston, West Lothian, United Kingdom

NHS Lanarkshire; 🇬🇧 Airdrie, North Lanarkshire, United Kingdom