Diabetic Foot UlcerNCT05762432
Diabetic Foot Ulcer Research Study
A study testing Wound Dressing and NHS Standard Dressing in people with Diabetic Foot Ulcer and Diabetic Foot Ulcer Neuropathic, run by Community Pharmacology Services Ltd at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Diabetic Foot Ulcer Ischemic
- What is being tested?
- Wound Dressing and NHS Standard Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Apr 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
NHS Lanarkshire
Airdrie, North Lanarkshire, ML6 0JS
Kaye McIntyre, 01236 748 748
- Recruiting
NHS Lothian
Livingston, West Lothian, EH54 6PP
Chris Jones, 01506 523 000
About this study
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
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.
Read the 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.
- Being tested
- Wound Dressing, NHS Standard Dressing
- Keywords
- Diabetes, Foot Ulcer, Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound DressingDevice
RTD Wound Dressing that is being investigated
NHS Standard DressingDevice
This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer
| Study group | Role | What they receive |
|---|---|---|
| Study Device | Experimental | 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. Receives: Device: Wound Dressing |
| Standard of Care | Active comparator | This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics. Receives: Device: NHS Standard Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Wound Healing
100% epithelialised
Measured: 12 weeks
Reduction in Wound Area
% reduction in size of Wound Area
Measured: 12 weeks
Secondary outcomes (2)
Wound Infection Rates
Rates at which the wound is infected
Measured: 12 weeks
Dressing Changes
Number of dressing changes required per week and in total
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start26 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Combination of normal standard of care and study device
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Pharmacology Services Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Keneric Healthcare
- Responsible party
- Sponsor
- Investigators
- Kaye McIntyre, MsC, Principal investigator, NHS Lanarkshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762432
- Sponsor's protocol ID
- CPS22.007
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05762432
- Acronym / sponsor ID
- CPS22.007
- Keywords
- Diabetes, Foot Ulcer, Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Community Pharmacology Services LtdUniversity, hospital or other
- Collaborators
- Keneric Healthcare
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Combination of normal standard of care and study device
| Arm | Type | Receives |
|---|---|---|
| Study Device | Experimental | Device: Wound DressingThis 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. |
| Standard of Care | Active comparator | Device: NHS Standard DressingThis arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound DressingRTD Wound Dressing that is being investigated | Device | Study Device |
| NHS Standard DressingThis is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer | Device | Standard of Care |
Primary outcome
Completion of Wound Healing
Time frame: 12 weeks
100% epithelialised
Reduction in Wound Area
Time frame: 12 weeks
% reduction in size of Wound Area
2 secondary outcomes
Wound Infection Rates
Time frame: 12 weeks
Dressing Changes
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. No data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaye McIntyre, MsC principal investigator
NHS Lanarkshire
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Dressing and NHS Standard Dressing in people with Diabetic Foot Ulcer and Diabetic Foot Ulcer Neuropathic, run by Community Pharmacology Services Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duncan Stang, MChS (07554333493, duncan.stang@lanarkshire.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Wound Healing (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.