Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05762432

Diabetic Foot Ulcer Research Study

Led by Community Pharmacology Services Ltd · Updated on 2026-01-26

100

Participants Needed

2

Research Sites

140 weeks

Total Duration

On this page

Sponsors

C

Community Pharmacology Services Ltd

Lead Sponsor

K

Keneric Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Diabetic Foot Ulcer Research Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

NHS Lanarkshire

Airdrie, North Lanarkshire, United Kingdom, ML6 0JS

Actively Recruiting

2

NHS Lothian

Livingston, West Lothian, United Kingdom, EH54 6PP

Actively Recruiting

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Research Team

D

Duncan Stang, MChS

CONTACT

K

Kaye McIntyre, MsC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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