Imaging and biomechanics of plantar foot soft tissues in association with foot ulcer risk in diabetes

Imaging and biomechanics of plantar foot soft tissues in association with foot ulcer risk in diabetes - Multimodal Tissue Assessment in Diabetic Foot Ulcer Risk

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57798

Enrollment

Registered

2024-12-24

Start date

2026-01-30

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Diabetic Foot Foot Ulcers Wounds on the sole of the foot in people with diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed diabetes mellitus type 1 or 2; 2. Age 18 or above; 3. Loss of protective sensation based on the presence of peripheral neuropathy; 4. Healed plantar foot ulcer of which the cause was repetitive stress, at the hallux or any of the metatarsal heads or midfoot.

Exclusion criteria

Exclusion criteria: 1. Foot ulcer present or a healed foot ulcer with another cause than from repetitive mechanical stress; 2. Active Charcot*s neuroarthropathy; 3. Foot infection, based on PEDIS classification; 4. Amputation of hallux or any more proximal region in the contralateral foot that prevents comparison with the healed site; 5. Severe ischaemia, determined by absent dorsalis pedis or tibialis posterior arterial pulses, combined with an ankle-brachial systolic blood pressure index

Design outcomes

Primary

Measure	Time frame
The primary parameter for this study is the Plantar Foot Soft Tissue Stiffness at the region of interest (ROI), defined as the extent to which the tissue resists deformation in response to an applied force.	—

Secondary

Measure	Time frame
Other relevant study parameters are: 1. Plantar Foot Soft Tissue Thickness at the ROI, defined as the distance from the bone to the outermost layer of the skin. 2. Plantar Fat Pad Migration at the ROI, defined as the progressive distal misplacement of the plantar fat pad from its former positioning; 3. Fat/Water Ratio in the plantar fat pad at the ROI, defined as the ratio between fat and water signals that reflects fat pad composition that can be evaluated via T1-weighted MRI chemical shifting imaging; 4. Metatarsophalangeal and inter-phalangeal joint angle; 5. Plantar pressure at the ROI (barefoot plantar pressures in all appropriate footwear measured using the Pedar-X system (Novel, GmbH, Munich, Germany); defined as the average of the average peak plantar pressure at the risk location(s) in all appropriate footwear) 6. Cumulative plantar tissue stress (defined as the average daily tissue stress; 7. Forefoot ulcer recurrence in 6 months.	—

Measure

Time frame

Other relevant study parameters are: 1. Plantar Foot Soft Tissue Thickness at the ROI, defined as the distance from the bone to the outermost layer of the skin. 2. Plantar Fat Pad Migration at the ROI, defined as the progressive distal misplacement of the plantar fat pad from its former positioning; 3. Fat/Water Ratio in the plantar fat pad at the ROI, defined as the ratio between fat and water signals that reflects fat pad composition that can be evaluated via T1-weighted MRI chemical shifting imaging; 4. Metatarsophalangeal and inter-phalangeal joint angle; 5. Plantar pressure at the ROI (barefoot plantar pressures in all appropriate footwear measured using the Pedar-X system (Novel, GmbH, Munich, Germany); defined as the average of the average peak plantar pressure at the risk location(s) in all appropriate footwear) 6. Cumulative plantar tissue stress (defined as the average daily tissue stress; 7. Forefoot ulcer recurrence in 6 months.

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Countries

Netherlands

Contacts

Public ContactA. V. Vicentini

Amsterdam UMC

a.vicentini@amsterdamumc.nl68250

Outcome results