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Diabetic Foot Ulcer Research Study

NCT05762432 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot Ulcer Neuropathic
  • Diabetic Foot Ulcer Ischemic

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

Sponsors & Collaborators

  • Keneric Healthcare

    collaborator UNKNOWN

  • Community Pharmacology Services Ltd

    lead OTHER

Principal Investigators

  • Kaye McIntyre, MsC · NHS Lanarkshire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-26
Primary Completion
2026-12-01
Completion
2027-01-01
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05762432 on ClinicalTrials.gov