Status:

RECRUITING

Diabetic Foot Ulcer Research Study

Lead Sponsor:

Community Pharmacology Services Ltd

Collaborating Sponsors:

Keneric Healthcare

Conditions:

Diabetic Foot Ulcer

Diabetic Foot Ulcer Neuropathic

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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...

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.

Key Trial Info

Start Date :

April 26 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2027

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05762432

Start Date

April 26 2024

End Date

January 1 2027

Last Update

January 26 2026

Active Locations (2)

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Page 1 of 1 (2 locations)

1

NHS Lanarkshire

Airdrie, North Lanarkshire, United Kingdom, ML6 0JS

2

NHS Lothian

Livingston, West Lothian, United Kingdom, EH54 6PP

Diabetic Foot Ulcer Research Study | DecenTrialz