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Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention (DIASSIST)

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Custom-made shoes: pressure-optimized
Custom-made indoor shoes: pressure optimized
Foot temperature monitoring
Education
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot Ulcer focused on measuring diabetes, foot ulcer, prevention, cost-utility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amsterdam UMCRecruiting
  • Reinier de Graaf GasthuisRecruiting
  • Máxima Medisch CentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multimodal care

Usual care

Arm Description

Multimodal personalised treatment

Usual care as offered to high-risk patients as offered in the Netherlands

Outcomes

Primary Outcome Measures

Cost-utility (as the primary economic outcome)
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
Adherence to wearing custom-made footwear (as the primary patient-related outcome)
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)
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

Secondary Outcome Measures

Cost-effectiveness
defined as the ratio between costs related to foot care and foot ulcer recurrence on any location of the foot
Plantar foot ulcer recurrence
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
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
Costs related to foot care (from a societal and medical perspective)
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.
Quality-adjusted life years
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.

Full Information

First Posted
January 17, 2022
Last Updated
August 2, 2022
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05236660
Brief Title
Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention
Acronym
DIASSIST
Official Title
Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
diabetes, foot ulcer, prevention, cost-utility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multimodal care
Arm Type
Experimental
Arm Description
Multimodal personalised treatment
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care as offered to high-risk patients as offered in the Netherlands
Intervention Type
Device
Intervention Name(s)
Custom-made shoes: pressure-optimized
Intervention Description
Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.
Intervention Type
Device
Intervention Name(s)
Custom-made indoor shoes: pressure optimized
Intervention Description
Pressure-optimized custom-made indoor shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months. Specifically designed for indoor use.
Intervention Type
Device
Intervention Name(s)
Foot temperature monitoring
Intervention Description
Personalised at-home daily foot temperature monitoring at high-risk regions.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Personalised patient education consisting of quantitative feedback on in-shoe pressures, temperature measurements and footwear use and, in addition, motivational interviewing where indicated and needed to improve device use.
Primary Outcome Measure Information:
Title
Cost-utility (as the primary economic outcome)
Description
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
Time Frame
12 months (full study period)
Title
Adherence to wearing custom-made footwear (as the primary patient-related outcome)
Description
defined as the percentage of steps taken in prescribed footwear, calculated by combining physical activity and wearing time measurements
Time Frame
12 months (full study period)
Title
Foot ulcer recurrence during the 12-months follow-up (as the primary clinical outcome)
Description
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
Time Frame
12 months (full study period)
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
defined as the ratio between costs related to foot care and foot ulcer recurrence on any location of the foot
Time Frame
12 months (full study period)
Title
Plantar foot ulcer recurrence
Description
following the definition of foot ulcer recurrence (outcome 3), but then limited to the plantar side of the foot
Time Frame
12 months (full study period)
Title
Foot ulcer recurrence at three predefined high-risk locations
Description
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
Time Frame
12 months (full study period)
Title
Costs related to foot care (from a societal and medical perspective)
Description
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.
Time Frame
12 months (full study period)
Title
Quality-adjusted life years
Description
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.
Time Frame
12 months (full study period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Vossen
Phone
+31683511105
Email
l.e.vossen@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sicco Bus, Prof
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Vossen
Phone
+31683511105
Email
l.e.vossen@amsterdamumc.nl
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Vossen
Phone
+31683511105
Email
l.e.vossen@amsterdamumc.nl
Facility Name
Máxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Vossen
Phone
+31683511105
Email
l.e.vossen@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be made available after an embargo period, to allow the research team to write all prespecified publications. The embargo period is required, as publications may often follow once the project has already ended. The embargo period will be a maximum 2 years, to allow the research sufficient time to finish the publications as specified in the protocol. If publications are available earlier, the embargo will end earlier. Conditions for reuse will apply, but have yet to be finalized.
IPD Sharing Time Frame
2 years after study completion and for 15 years
IPD Sharing Access Criteria
to be determined

Learn more about this trial

Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

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