Diabetic Foot Ulcer Research Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer Ischemic
• Intervention / Treatment: Device: Wound Dressing; Device: NHS Standard Dressing

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Duncan Stang, MChS; Phone Number: 07554333493; Email: duncan.stang@lanarkshire.scot.nhs.uk
• Study Contact Backup: Name: Kaye McIntyre, MsC; Phone Number: 01236 748748; Email: Kaye.McIntyre@lanarkshire.scot.nhs.uk

Study Locations

• United Kingdom
  • North Lanarkshire
    • Airdrie, North Lanarkshire, United Kingdom, ML6 0JS
      • Recruiting
      • NHS Lanarkshire
      • Contact: Kaye McIntyre; Phone Number: 01236 748 748
  • West Lothian
    • Livingston, West Lothian, United Kingdom, EH54 6PP
      • Recruiting
      • NHS Lothian
      • Contact: Chris Jones; Phone Number: 01506 523 000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Wound Dressing; RTD Wound Dressing that is being investigated
Active Comparator: Standard of Care; 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; This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Community Pharmacology Services Ltd
• Collaborators: Keneric Healthcare
• Investigators: Principal Investigator: Kaye McIntyre, MsC, NHS Lanarkshire

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Diabetic Foot Ulcer; Foot Ulcer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Diabetic Foot; Foot Ulcer; Equipment and Supplies; Bandages
• Other Study ID Numbers: CPS22.007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data will be shared.

Drug and device information, study documents

• 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