Health TrialsbyHealthPanel

Diabetic Foot Ulcer Research Study

ConditionsDiabetic Foot UlcerDiabetic Foot Ulcer NeuropathicDiabetic Foot Ulcer Ischemic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCommunity Pharmacology Services Ltd

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Study DeviceExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Completion of Wound Healing

100% epithelialised

Time frame
12 weeks
2

Reduction in Wound Area

% reduction in size of Wound Area

Time frame
12 weeks

Secondary outcomes

1

Wound Infection Rates

Rates at which the wound is infected

Time frame
12 weeks
2

Dressing Changes

Number of dressing changes required per week and in total

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Community Pharmacology Services Ltd

Lead sponsor

Keneric Healthcare

Collaborator

Source ClinicalTrials.gov
Apply now