NCT05762432

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Apr 2024Jan 2027

First Submitted

Initial submission to the registry

February 17, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 26, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

February 17, 2023

Last Update Submit

January 23, 2026

Conditions

Diabetic Foot UlcerDiabetic Foot Ulcer NeuropathicDiabetic Foot Ulcer Ischemic

Keywords

DiabetesFoot UlcerDiabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

  • Completion of Wound Healing

    100% epithelialised

    12 weeks

  • Reduction in Wound Area

    % reduction in size of Wound Area

    12 weeks

Secondary Outcomes (2)

  • Wound Infection Rates

    12 weeks

  • Dressing Changes

    12 weeks

Study Arms (2)

Study Device

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Wound DressingDEVICE

RTD Wound Dressing that is being investigated

Study Device
NHS Standard DressingDEVICE

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

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS Lanarkshire

Airdrie, North Lanarkshire, ML6 0JS, United Kingdom

RECRUITING

NHS Lothian

Livingston, West Lothian, EH54 6PP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusFoot Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Kaye McIntyre, MsC

    NHS Lanarkshire

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duncan Stang, MChS

CONTACT

07554333493duncan.stang@lanarkshire.scot.nhs.uk

Kaye McIntyre, MsC

CONTACT

01236 748748Kaye.McIntyre@lanarkshire.scot.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Subjects will be randomised 1:1 to RTD Wound Dressing or standard of care dressing. Randomisation will be in blocks of four.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Combination of normal standard of care and study device
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

March 9, 2023

Study Start

April 26, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

No data will be shared.

Locations

GB(2)