Diabetic Foot Ulcer Research Study | NCT05762432

Studies
Diabetic Foot Ulcer Research Study

NCT05762432

Sponsor

Community Pharmacology Services Ltd

Status

Recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Diabetic Foot Ulcer
Diabetic Foot Ulcer Neuropathic
Diabetic Foot Ulcer Ischemic

Interventions

Wound Dressing
NHS Standard Dressing

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2024Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Feb 17, 2023

First Submission Date that Met QC Criteria

Feb 28, 2023

First Posted Date

Mar 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2026

Last Update Posted Date

Jan 26, 2026Actual

Name	Class
Keneric Healthcare	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Wound Dressing	Device	RTD Wound Dressing that is being investigated	Study Device

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Duncan Stang, MChS	Contact	07554333493		duncan.stang@lanarkshire.scot.nhs.uk
Kaye McIntyre, MsC	Contact	01236 748748		Kaye.McIntyre@lanarkshire.scot.nhs.uk

Overall Officials

Name	Affiliation	Role
Kaye McIntyre, MsC	NHS Lanarkshire	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS Lanarkshire	Recruiting	Airdrie	North Lanarkshire	ML6 0JS	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No data will be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot
D003920	Diabetes Mellitus
D016523	Foot Ulcer

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided