N/A
Completed N=82
Development and Testing of a New Generation of Diabetic Footwear
Diabetes Complications · Diabetic Neuropathies
Source: ClinicalTrials.gov NCT01816906 ↗
Enrolled (actual)
82
Serious AEs
5.8%
Results posted
Jun 2019
Primary outcomePrimary: Postural Sway During Shod Standing — 4.3; 3.1 cm^2
Summary
This particular trial is looking to compare the effectiveness of two types of foot bed/ sole materials used within diabetic footwear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postural Sway During Shod Standing |
4.3; 3.1 | — |
| SECONDARY Ankle Strength Left 1 |
111; 116 | — |
| SECONDARY Ankle Strength Left 2 |
135; 140 | — |
| SECONDARY Ankle Strength Right 1 |
107; 110 | — |
| SECONDARY Ankle Strength Right 2 |
132; 141 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Diabetes by WHO criteria
- Lack of sensation to 10 g monofilament or VPT >25 V
- Ability to walk independently for 10 m
- No ambulatory status
- No severe foot deformity like Charcot foot
- Willingness to be assigned to randomisation of footwear
- At least one palpable pedal pulse on each foot
Exclusion Criteria
- Previous ulceration or current Trophic Ulcers
- Active foot infection
- Alzheimer and dementia and impaired cognitive function
- Gross abnormality or Foot deformity requiring footbed customisation
- Chronic Kidney Disease
- Hammer toes
- Previous foot surgeries
Data sourced from ClinicalTrials.gov (NCT01816906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.