Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Not Applicable

Active, not recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Foot temperature monitoring; Behavioral: Education

• Registration Number: NCT05236660
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

Preventing foot ulcers in people with diabetes can reduce costs and increase quality of life. Despite availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesise that a multimodal approach incorporating a variety of orthotic interventions that matches an individual person's need can reduce ulcer recurrence with beneficial cost-effectiveness and cost-utility.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-11
• Study Start: 2022-03-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Diabetes mellitus type 1 or 2
• Age 18 years or above
• Loss of protective sensation based on the presence of peripheral neuropathy
• A healed plantar foot ulcer or foot amputation in the preceding 4 years until two weeks before study inclusion
• In possession of custom-made orthopaedic shoes, defined as "Orthopaedic shoes type A" or "Orthopaedic shoes type B" , or Orthopaedic Provision in Regular Footwear (OVAC), according to the Dutch healthcare system
• Ability to provide informed consent

Exclusion Criteria

• Foot ulcer or open amputation site(s)
• Active Charcot's neuroarthropathy
• Foot infection, based on criteria of the PEDIS classification
• Amputation proximal to the metatarsal bones in both feet
• Healed ulcer on the apex of digitus 2-5 as the only ulcer location in the past 4 years, as surgical intervention (flexor tenotomy) is a more likely and guideline-recommended treatment for such patients, rather than the multimodal care under investigation
• Severe illness that would make 12-months survival unlikely, based on the clinical judgment by the physician
• Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on clinical judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal care	Foot temperature monitoring	Multimodal personalised treatment
Multimodal care	Education	Multimodal personalised treatment

Primary Outcome Measures

Name	Time	Method
Adherence to wearing custom-made footwear (as the primary patient-related outcome)	12 months (full study period)	defined as the percentage of steps taken in prescribed footwear, calculated by combining physical activity and wearing time measurements
Foot ulcer recurrence during the 12-months follow-up (as the primary clinical outcome)	12 months (full study period)	defined as "a break of the skin of the foot that involves as a minimum the epidermis and part of the dermis, in a person who has a history of foot ulceration, irrespective of location and time since the previous foot ulcer", with the first ulcer in the study period recorded as primary outcome and percentage participants with ulcer recurrence on group level as primary outcome
Cost-utility (as the primary economic outcome)	12 months (full study period)	defined as the ratio between costs related to foot care and quality-adjusted life years, based on the health utilities associated with the scoring profiles on the EQ-5D-5L with Dutch reference scores

Secondary Outcome Measures

Name	Time	Method
Costs related to foot care (from a societal and medical perspective)	12 months (full study period)	Costs will be calculated for each participant as the product sum of resource volume data and their respective unit costs. Resource volume data will be obtained from the completed study specific versions of the institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ), as these contain the volume data on healthcare resource utilization, out-of-pocket expenses and loss of productivity related to foot care. Foot care includes both care for ulcer prevention (e.g. podiatry appointments, rehabilitation physician consultations) and for ulcer treatment (e.g. multidisciplinary treatment, hospitalization, surgery). Reference prices for unit costs will be based on the most recent Dutch manual for costing in healthcare research available at the time of analysis. All costs will be summed during the entire study period.
Cost-effectiveness	12 months (full study period)	defined as the ratio between costs related to foot care and foot ulcer recurrence on any location of the foot
Quality-adjusted life years	12 months (full study period)	based on the health utilities associated with the scoring profiles on the EQ-5D-5L with Dutch reference scores. This will be monitored during the entire study period.
Plantar foot ulcer recurrence	12 months (full study period)	following the definition of foot ulcer recurrence (outcome 3), but then limited to the plantar side of the foot
Foot ulcer recurrence at three predefined high-risk locations	12 months (full study period)	following the definition of foot ulcer recurrence (outcome 3), but then limited to a maximum 3 high risk locations per participant, specified at the start of the study, based on barefoot pressures, ulcer history, pre-ulcerative lesions or signs of abundant callus

Trial Locations

Locations (5)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Rode Kruis Ziekenhuis; 🇳🇱 Beverwijk, Netherlands

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

Spaarne Gasthuis; 🇳🇱 Hoofddorp, Netherlands

Máxima Medisch Centrum; 🇳🇱 Veldhoven, Netherlands