Diabetic Foot Ulcer Research Study

Sponsor

Community Pharmacology Services Ltd (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05762432

Collaborator

Keneric Healthcare (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer Diabetic Foot Ulcer Neuropathic Diabetic Foot Ulcer Ischemic	Device: Wound Dressing Device: NHS Standard Dressing	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Combination of normal standard of care and study deviceCombination of normal standard of care and study device

Masking:

None (Open Label)

Masking Description:

Subjects will be randomised 1:1 to RTD Wound Dressing or standard of care dressing. Randomisation will be in blocks of four.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Device 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 RTD Wound Dressing that is being investigated
Active Comparator: Standard of Care 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 This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer

Arm

Intervention/Treatment

Experimental: Study Device

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

RTD Wound Dressing that is being investigated

Active Comparator: Standard of Care

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

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

Outcome Measures

Primary Outcome Measures

Completion of Wound Healing [12 weeks]
100% epithelialised
Reduction in Wound Area [12 weeks]
% reduction in size of Wound Area

Secondary Outcome Measures

Wound Infection Rates [12 weeks]
Rates at which the wound is infected
Dressing Changes [12 weeks]
Number of dressing changes required per week and in total

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Community Pharmacology Services Ltd
Keneric Healthcare

Investigators

Principal Investigator: Kaye McIntyre, MsC, NHS Lanarkshire

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Community Pharmacology Services Ltd

ClinicalTrials.gov Identifier:

NCT05762432

Other Study ID Numbers:

CPS22.007

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Community Pharmacology Services Ltd

Diabetes

Foot Ulcer

Diabetic Foot Ulcer

Additional relevant MeSH terms:

Diabetic Foot

Foot Ulcer

Ulcer

Study Results

No Results Posted as of Mar 9, 2023