Diabetes Diabetes Mellitus
Conditions
Interventions
None listed
Sponsors
Ziekenhuisgroep Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus, type 1 or 2 2. Age >18 years old 3. Highest risk for plantar ulceration: - Peripheral sensory neuropathy and - Healed plantar pressure ulcer in the last 6 months and - Foot deformity present 4. Ability and willingness to cooperate with the requirements of the study: - Have home telephone - 3-month availability for the study - Conform to the protocol (i.e. receive standard care and make use of the foot scanner at the listed frequencies)
Exclusion criteria
Exclusion criteria: 1. Amputation at a level beyond the toes in either foot 2. Inability to follow the instructions for scanning of the foot due to physical, visual, or mental conditions 3. Intention to move outside of study area resulting in a change of hospital for foot care 4. Intention to spend more than one week from home (e.g. vacation) 5. Dependent in activities of daily living (ADL). 6. Parallel participation in another diabetic foot trial 7. Physical or mental conditions of which the patients* own physician feels they are, in the best interest of the patient, exclusion for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility using the Vincent50 foot scanner in the home environment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Validity and reproducibility; - Patient satisfaction; - Patient compliance; - Patient quality of life; - Percentage of high-quality photographs that the clinician finds suitable for assessment; - Time needed for referral; - Percentage of justified referrals; - Total cost for using the Vincent50 foot scanner. | — |
Countries
Netherlands
Outcome results
None listed