At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Wound Dressing (device), NHS Standard Dressing (device)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- Wound Dressing — device: RTD Wound Dressing that is being investigated · NHS Standard Dressing — device: This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2024-04-26
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for diabetic foot ulcer
- • NA - 100 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with diabetic foot ulcer
Where?
- • Airdrie - NHS Lanarkshire
- • Livingston - NHS Lothian
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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 agreement to take part to participation in the trial...
- ✓DFU is \>10mm2 and \<100mm2
Who cannot take part
- ✗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...
- ✗Suspected cancer in the wound
- ✗Critical limb ischaemia
- ✗Pregnant or breastfeeding females
See the full criteria
Where Is This Study? (2 UK sites)
NHS Lanarkshire
Airdrie ML6 0JS, United Kingdom
NHS Lothian
Livingston EH54 6PP, United Kingdom
How to Get in Touch
Duncan Stang, MChS
Sponsor contactCONTACT
Kaye McIntyre, MsC
Sponsor contactCONTACT