Diabetic Foot Ulcer Research Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wound Dressing, NHS Standard Dressing.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer Ischemic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Device Wound Dressing
RTD Wound Dressing that is being investigated - Device NHS Standard Dressing
This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer
Primary outcome measures
- Completion of Wound Healing [Time frame: 12 weeks]
- Reduction in Wound Area [Time frame: 12 weeks]
Secondary outcome measures (2)
- Wound Infection Rates [Time frame: 12 weeks]
- Dressing Changes [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 2 centers
- NHS Lanarkshire — Airdrie
- NHS Lothian — Livingston
Identifiers
NCT: NCT05762432 · CPS22.007