Diabetic Foot Ulcer, Diabetic Foot Ulcer Ischemic, Diabetic Foot Ulcer Neuropathic
Conditions
Keywords
Diabetes, Foot Ulcer, Diabetic Foot Ulcer
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.
Interventions
DEVICEWound Dressing
RTD Wound Dressing that is being investigated
DEVICENHS Standard Dressing
This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer
Sponsors
Community Pharmacology Services Ltd
Keneric Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Subjects will be randomised 1:1 to RTD Wound Dressing or standard of care dressing. Randomisation will be in blocks of four.
Intervention model description
Combination of normal standard of care and study device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Wound Healing | 12 weeks | 100% epithelialised |
| Reduction in Wound Area | 12 weeks | % reduction in size of Wound Area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Contacts
CONTACTDuncan Stang, MChS
CONTACTKaye McIntyre, MsC
PRINCIPAL_INVESTIGATORKaye McIntyre, MsC
NHS Lanarkshire
Outcome results
None listed