N/A N=82 Randomized Prevention

Development and Testing of a New Generation of Diabetic Footwear

Diabetes Complications · Diabetic Neuropathies

Bottom Line

View on ClinicalTrials.gov: NCT01816906 ↗

Enrolled (actual)

Serious AEs

5.8%

Results posted

Jun 2019

Primary outcome: Primary: Postural Sway During Shod Standing — 4.3; 3.1 cm^2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Footwear :PU (Device); Footwear: MCP (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Staffordshire University
Primary completion: Apr 2014

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	—

Summary

This particular trial is looking to compare the effectiveness of two types of foot bed/ sole materials used within diabetic footwear.

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

View full record on ClinicalTrials.gov →

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.