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Completed

NCT Number: NCT02579070

Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Has either type 1 or type 2 diabetes
  • Has intact feet as defined by the absence of a skin breakdown below the malleoli.
  • Has neuropathy confirmed by impaired sensation to neurothesiometer (vibration perception threshold > 25 volts on one OR both feet)
  • Has a past history of ≥1 foot ulceration (s) which has (have) resolved in the last 3 months
  • Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
  • Has no history of peripheral arterial disease
  • Has footwear which in the opinion of the investigator is not likely to cause pressure damage
  • Must be able to provide meaningful written informed consent for the study

Exclusion criteria

  • Is aged <18
  • Has foot deformity that in the opinion of the investigator would interfere with the interpreting of the results of the study.
  • Has previous history of foot surgery which in the opinion of the study investigator could interfere with the interpreting the results of the study
  • Has active foot ulceration and infection
  • Has active Charcot osteoarthropathy
  • Has established Charcot foot deformity that in the opinion of the study investigator would interfere with the interpreting of the results of the study.
  • Has any uncontrolled illness that, in the opinion of the study investigator, would interfere with interpreting the results of the study
  • Has an implantable electronic device

Treatment and study plan

DFUPS

Device

The DFUPS device is a two-camera instrument for capturing images of feet.

Primary outcomes

  1. Percentage of patients developing a foot ulcer

    Time frame: 12 months

Secondary outcomes

  1. Time to ulceration

    Time frame: 12 months

  2. Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • Freeman Health System
  • National Institute for Health Research, United Kingdom
  • National Physical Laboratory
  • Pennine Acute Hospitals NHS Trust
  • Photometrix
  • University of South Wales

Registry information

Official study title

Efficacy and Safety of Diabetic Foot Ulcer Prevention System (DFUPS) - a Single Blind Randomised Clinical Trial in Diabetic Foot Patients at High Risk of Foot Ulceration

Acronym: DFUPS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2015
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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