Diabetic Foot Ulcer Prevention System (DFUPS)

King's College Hospital NHS Trust

Status and phase: Completed; Phase 1

Conditions: Diabetic Foot

Treatments: Device: DFUPS

Study type: Interventional

Funder types: Other

Identifiers

NCT02317835

version 2 (02/3/2015)

Details and patient eligibility

About

To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 18 years or older
2. Has no history of diabetes
3. Has no previous history of foot ulceration
4. Has no previous history of foot surgery
5. Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
6. Has no history of peripheral neuropathy
7. Has no history of peripheral arterial disease
8. Must be able to provide meaningful written informed consent for the study

Exclusion criteria

1. Has active foot ulceration and infection
2. Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
3. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
4. Has an implantable electronic device
5. Is aged <18

Trial design

105 participants in 1 patient group

Study in healthy volunteers

Other group

Description:

Skin foot temperature measurement by DFUPS device

Treatment:

Device: DFUPS