DIASSIST: Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05236660
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
126
3
2
28
42
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Custom-made shoes: pressure-optimized
  • Device: Custom-made indoor shoes: pressure optimized
  • Device: Foot temperature monitoring
  • Behavioral: Education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial
Actual Study Start Date :
Mar 2, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multimodal care

Multimodal personalised treatment

Device: Custom-made shoes: pressure-optimized
Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.

Device: Custom-made indoor shoes: pressure optimized
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.

Device: Foot temperature monitoring
Personalised at-home daily foot temperature monitoring at high-risk regions.

Behavioral: Education
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.

No Intervention: Usual care

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amsterdam UMC Amsterdam Netherlands
2 Reinier de Graaf Gasthuis Delft Netherlands
3 Máxima Medisch Centrum Veldhoven Netherlands

Sponsors and Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Sicco Bus, Prof, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sicco Bus, PhD, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT05236660
Other Study ID Numbers:
  • NL78943.018.21
First Posted:
Feb 11, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sicco Bus, PhD, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022