Clinical trial NCT05762432: Diabetic Foot Ulcer Research 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Foot Ulcer Neuropathic
Diabetic Foot Ulcer Ischemic
Keywords: Diabetes
Foot Ulcer
Diabetic Foot Ulcer
Lead sponsor: Community Pharmacology Services Ltd
Sponsor class: OTHER
Collaborators: name: Keneric Healthcare
First posted: 2023-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Combination of normal standard of care and study device
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Completion of Wound Healing
timeFrame: 12 weeks
measure: Reduction in Wound Area
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound Infection Rates
timeFrame: 12 weeks
measure: Dressing Changes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Airdrie
country: United Kingdom
facility: NHS Lanarkshire
state: North Lanarkshire
city: Livingston
country: United Kingdom
facility: NHS Lothian
state: West Lothian
Study officials:
affiliation: NHS Lanarkshire
name: Kaye McIntyre, MsC
role: PRINCIPAL_INVESTIGATOR
References: