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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25577

Enrollment

Registered

2021-04-02

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus with loss of protective sensation

Interventions

Each participant will walk on a treadmill during four conditions: 1) Unadapted reference shoe (Dr.Comfort, Mequon, WI, USA) + standard insole (visit 1) 2) Unadapted reference shoe + self-adjusting ins

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
In-shoe plantar pressures, measured with a pressure insole (Pedar-X): 1. Peak Pressures (PP) 2. Pressure Time Integral (PTI) Balance with and without perturbations, measured with clinical tests and a force plate treadmill: 1. Time taken to stand up-walk- and sit (TUG) 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) 3. Margins of stability (MOS) during normal gait, AP & ML perturbations (dynamic balance)	—

Measure

Time frame

In-shoe plantar pressures, measured with a pressure insole (Pedar-X): 1. Peak Pressures (PP) 2. Pressure Time Integral (PTI) Balance with and without perturbations, measured with clinical tests and a force plate treadmill: 1. Time taken to stand up-walk- and sit (TUG) 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) 3. Margins of stability (MOS) during normal gait, AP & ML perturbations (dynamic balance)

—

Secondary

Measure	Time frame
Secondary study parameters: kinetics and kinematics of the lower extremities (Vicon)	—

Contacts

Public ContactAthra Malki

UMCG

a.malki@umcg.nl0655257183

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)