Measuring Plantar Pressures in Diabetic Patients With Lateral Forefoot Amputation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorNanyang Technological University
About this trial
This study aims to understand how pressure is placed on the bottom of the foot when people walk after a lateral forefoot amputation (for example, removal of the 5th toe).
Podiatrists have noticed that people with this type of amputation often develop new foot wounds (ulcers) than other types of foot amputation. By measuring foot pressure during walking, we hope to:
* Identify areas of high pressure ("hotspots") * Understand walking patterns after amputation * Identify biomechanical factors related to diabetic ulcers and foot amputations * Design better footwear and insoles in the future based on this information
The hypothesis is that people with lateral forefoot amputation have higher plantar pressures on the remaining parts of their foot.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21 years
Diagnosed with type 2 diabetes
Presence of a healed unilateral lateral forefoot amputation (at least 5th MPJ, up to any level including the 2nd toe and 2nd ray)
Ability to walk 10 meters unaided or with simple devices
Disqualifiers
Amputation or partial amputation of the hallux and any bones higher than midfoot (cuneiforms, cuboid, navicular, calcaneus) on the affected foot
Major lower limb amputation (above ankle), of other leg
Severe gait impairments unrelated to foot amputation (stroke, foot drop etc)
Other foot deforming disease such as, but not limited to, charcot neuroarthropathy, rheumatoid arthritis etc.
Trial population
Tertiary Public Hospital
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 2 trial groupsGroup A: Amputee
Group B: Control
Trial outcomes
Primary outcomes
1
Plantar pressure
\- Peak plantar pressure (PPP), which indicates the highest pressure recorded within a single stance phase.
Time frame
upon enrolment2
Plantar pressure
Mean peak pressure - obtained by averaging the pressures across several steps
Time frame
upon enrolment3
Plantar pressure
Pressure-time integral (PTI) measures the cumulative pressure exerted on a specific location over the period of the stance phase
Time frame
upon enrolmentSecondary outcomes
1
Plantar pressure
Anatomical location of peak pressure based on pressure pattern heatmap (picture form)
Time frame
upon enrolment2
Plantar pressure
center of pressure line
Time frame
upon enrolment3
prospective reulceration rate
1-year reulceration rate
Time frame
1 year from enrolmentSponsors and contacts
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Source ClinicalTrials.gov