ISRCTN15526470
Completed
Phase 2
An investigation of a smart insole, for the purpose of improving sensory response in people with diabetic peripheral neuropathy - SMARTSOLE
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetic peripheral neuropathy due to type 2 diabetes
- Sponsor
- Manchester Metropolitan University
- Enrollment
- 22
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38536962/ (added 06/06/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of type 2 diabetes mellitus
- •2\. Aged \>18 years
- •3\. Presence of at least one pedal pulse
- •4\. Presence of moderate diabetic peripheral neuropathy defined by a vibration perception threshold \> 15V
- •5\. Ability to walk unaided for 30 steps
- •6\. Able to understand all of the study requirements
- •7\. Fit shoe size UK 8\-12
Exclusion Criteria
- •1\. Active foot ulcer
- •2\. NHS prescription footwear
- •3\. Lower limb amputation (anything more than amputation of two lesser toes)
- •4\. Severe deformity due to Charcot Neuroarthropathy
- •5\. Major foot deformities, including diabetes and non\-diabetes\-related deformities
- •6\. Dementia or other cognitive impairment
- •7\. Significant cardiopulmonary or other systemic disease limiting the patient’s ability to walk 30 steps
- •8\. Person with bodyweight greater than 100kg (due to insole device limitations)
- •9\. Use of a pacemaker
- •10\. Inability to understand verbal and written information in English
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of WalkingBalanceNCT03663816University of Florida15
Completed
Not Applicable
Intelligent sensor-equipped shoe insole for patients with diabetic neuropathy for prophylaxis of foot ulcers (ulcer)E11.74: Diabetes mellitus, type 2 With multiple complications With diabetic foot syndrome, not described as derailedE11.73: Diabetes mellitus, type 2 With multiple complications With other multiple complications, referred to as derailedE11Type 2 diabetes mellitusDRKS00013798Otto-von-Giericke University MagdeburgMedical Faculty286
Completed
Not Applicable
FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After StrokeStrokeGait Disorders, NeurologicNCT04266743FeetMe30
Completed
Not Applicable
Wearable Technology to Assess Gait Function in SMA and DMDSpinal Muscular Atrophy Type 3Duchenne Muscular DystrophyNCT04193085Columbia University39
Completed
Not Applicable
Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles on the Symptoms and Quality of Life of Patients With Chronic Venous DiseaseVenous DiseaseQuality of LifeSymptoms and SignsNCT06620120Millet Innovation50