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Effectiveness of using 3D-Printed insoles in preventing diabetic foot ulcers for people with type 2 diabetes: an assessor-blinded randomised control trial in Thai patients

Effectiveness of using 3D-Printed insoles in preventing diabetic foot ulcers for people with type 2 diabetes: an assessor-blinded randomised control trial in Thai patients

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241022005
Enrollment
32
Registered
2024-10-22
Start date
2025-07-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with diabetes mellitus type 1 or 2 Diabetes Mellitus DM foot ulcer

Interventions

The foot imprinted foam will be fabricated with traditional method.,The foot imprinted foam of participants in 3D group, will be scan using EinScan Pro HD Handheld, the digital data will be adjusted
Active Comparator Device,Experimental Device
institute-made insole,3D-Printed insoles

Sponsors

Office of the National Economic and Social Development Council
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Been diagnosed with DM (either type I or II) 2. Age 18 years old or more 3. Evidence of peripheral neuropathy (diagnosed by 10g monofilament test) or DM foot ulcer Wagner classification grade 0 (skin at risk) 4. No evidence of other neurological or musculoskeletal problems that would affect body balance, standing and walking ability 5. The volunteer who has had DM foot ulcer, must completely heal at least 18 months before attending the protocol

Exclusion criteria

Exclusion criteria: 1. Active DM foot ulcer 2. The volunteer who are not able to follow the protocol eg. duration of insole wearing, reporting of a new potential DM foot ulcer, untreated hearing loss or visual impairment

Design outcomes

Primary

MeasureTime frame
Ulcer every follow up time (4, 6 and 12 months) visualization

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactNantawan Koonalinthip

Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University

col_kate@hotmail.com0929264562

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026