Diabetic Foot Ulcer Research Study

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05762432
• Other study ID #: CPS22.007
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Community Pharmacology Services Ltd
• Contact: Duncan Stang, MChS
• Phone: 07554333493
• Email: duncan.stang[@]lanarkshire.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Diabetic Foot Ulcer Ischemic
• Diabetic Foot Ulcer Neuropathic
• Foot Ulcer
• Ulcer

Intervention

Device:
• Wound Dressing
RTD Wound Dressing that is being investigated
• NHS Standard Dressing
This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Community Pharmacology Services Ltd	Keneric Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Wound Healing	100% epithelialised	12 weeks
Primary	Reduction in Wound Area	% reduction in size of Wound Area	12 weeks
Secondary	Wound Infection Rates	Rates at which the wound is infected	12 weeks
Secondary	Dressing Changes	Number of dressing changes required per week and in total	12 weeks