Development of a vibrating FO combined with a noise-based technique and SR for stimulating tactile sensation of plantar surface of the foot in type 2 diabetic patients with peripheral neuropathy

Development of a vibrating FO combined with a noise-based technique and stochastic resonance for stimulating tactile sensation in type 2 diabetic patients with peripheral neuropathy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230530002

Enrollment

Registered

2023-05-30

Start date

2023-06-12

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

Type 2 diabetic patients with peripheral neuropathy Diabetes Peripheral Neuropathy Tactile Sensation Foot Orthoses Vibrating Stochastic Resonance

Interventions

Using vibrating foot orthoses in stimulating tactile sensation.,No using vibrating foot orthoses .

Experimental Device,No Intervention No treatment

Use Vibrating Foot Orthoses,No Use Vibrating Foot Orthoses

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosis of type 2 diabetes mellitus. (2) Diagnosis of peripheral neuropathy on the feet, and there is numbness all over the soles of the foot. (3) No muscle weakness in lower extremity and muscle strength at bleast 4, grading by the Medical Research Council (MRC). (4) No skin problems in the feet, such as ulcers, wounds, blisters, abrasions, calluses, skin irritations, open skin areas, or burns, etc. in the area of the foot and lower leg, and no skin diseases caused by viruses, fungi, or bacteria. (5) Foot structure as flat feet or high arches can participate in these research studies. (6) Subjects must have ability to perceive vibrational stimulation. (7) Subjects have sufficient cognitive and language abilities to follow instructions, e.g., no dementia, no pronounced hearing loss. (8) Subjects have ability to sit for at least 60 minutes. (9) Vital signs, neurological signs and medical conditions are stable.

Exclusion criteria

Exclusion criteria: (1) Musculoskeletal problems such as severe pain in any joints of the foot. (2) Contracture of the ankle, or foot joint that hindered using the vibrating Foot Orthoses. (3) Cognitive impairment (Thai Mental State Examination Scores less than 23). (4) Subjects have other diseases that are complicated by diabetes, such as epilepsy, brain disorders, and seizure. (5) Subjects have a medical condition that may be affected or affected by participating in the research project. (6) Allergy to the vibrating FO materials.

Design outcomes

Primary

Measure	Time frame
Vibration Perception Threshold (VPT) immediately micron	—

Secondary

Measure	Time frame
N/A N/A N/A	—

Countries

Thailand

Contacts

Public ContactWachirayongyot Thimabut

Institute of Automation, University of Chinese Academy of Sciences

wachirayongyot@gmail.com0862520257

Outcome results

None listed

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