Individually optimized rocker profile and self-adapting insole to reduce the plantar peakpressure in Diabetic patients with loss of protective sensatio

Recruiting

Conditions: Diabetes Mellitus with loss of protective sensation

Registration Number: NL-OMON25577

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

For the patients with Diabetes Mellitus:
- Adult
- Diabetes mellitus (type I or II)
- Loss of protective sensation (10 gr filament & 128Hz tunning fork)
- Ambulatory without use of walking aids (with the exception of the use of orthopaedic footwear)
- Shoe size between 36 and 46

For the healthy reference group:
- Ambulatory without use of walking aids
- Age between 40-70 year
- Shoe size between 36-46

Exclusion Criteria

For the patients with Diabetes Mellitus:
- Current ulcer(s) and ulcer(s) in the past
- Use of walking aids (with the exception of the use of orthopaedic footwear)
- Extreme foot deformations (e.g. Charcot foot) or toe or foot amputations that do not allow participants to fit semi-ready-to-wear shoes
- Body weight >130kg

For the healthy reference group:
- Use of walking aids
- Foot complications (injuries that can influence gait) that do not allow participants to fit ready-to-wear shoes
- Body weight >130kg
- Any self-reported injury or disease that affects walking ability

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-shoe plantar pressures, measured with a pressure insole (Pedar-X):<br>1. Peak Pressures (PP)<br>2. Pressure Time Integral (PTI)<br><br>Balance with and without perturbations, measured with clinical tests and a force plate treadmill:<br>1. Time taken to stand up-walk- and sit (TUG)<br>2. Root Mean Square (RMS) of net anterior-posterior (AP) & medio-lateral (ML) Center of Pressure (COP) direction during eyes open and closed condition (static balance)<br>3. Margins of stability (MOS) during normal gait, AP & ML perturbations (dynamic balance)

Secondary Outcome Measures