N/A
N=3
Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses
Diabetes Mellitus · Peripheral Neuropathy · Orthotic Device
Bottom Line
View on ClinicalTrials.gov: NCT03618628 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Peak Plantar Pressure — 75.3; 14.2; 14.5; 22.8 Newtons per squared centimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carbon Fiber Off Loading Orthosis (CFO) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plantar Pressure |
75.3; 14.2; 14.5; 22.8; 3.5; 6.6 | — |
Summary
The purpose of this study is to determine the ability of carbon fiber off loading orthoses to reduce plantar pressure while providing an augmented plantarflexor power to improve walking and function. Results of this study could lead to increased use of carbon fiber off loading orthoses for patients with diabetes, peripheral neuropathy, and foot wounds as a way augmenting wound healing and preventing future recurrences of wounds.
Eligibility Criteria
Inclusion Criteria
- Daily life includes a minimum of moderate activity level (variable cadence walking)
- Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
- Diagnosis of diabetes mellitus and peripheral neuropathy
- Ability to ambulate in the community (K-level ≥ 2)
- Age > 21 years
Exclusion Criteria
- Unable to ambulate and complete testing required for study participation.
- Severe foot deformity of the hindfoot or any deformity of the foot with a dislocation resulting in a bony prominence on the plantar/weightbearing surface of the foot.
- Neurological diseases that affects walking
Data sourced from ClinicalTrials.gov (NCT03618628). 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.