Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers

NCT05687643 | Unknown

• 1 other identifier: VS21/143856
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Stain Analysis Mapping of the Plantar surface (STAMP) is a method designed by the University of Leeds to measure 'in-shoe' strain patterns on the plantar surface of the foot. Shear Load Inductive Plantar Sensing (SLIPS) is an insole designed by the University of Leeds to measure plantar shear stress and plantar pressure. This study aims to compare plantar strain using STAMP and plantar shear stress and plantar pressure using SLIPS in two groups of patients with diabetes; high risk patients with a recently healed plantar ulcer and low risk patients (according to the NICE definition).

Conditions

Diabetic Foot; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Peak plantar strain

  The difference in peak plantar strain (%) (as measured with STAMP) between the DFU and low risk group

  At clinical visit on study entry

Secondary Outcomes (4)

• Regional peak plantar strain

  At clinical visit on study entry

• Regional peak plantar shear

  At clinical visit on study entry

• Peak Plantar pressure

  At clinical visit on study entry

• Regional Peak Plantar pressure

  At clinical visit on study entry

Study Arms (2)

Diabetic Foot Ulcer (DFU) group

Inclusion criteria: 1. Age \>18 2. A diagnosis of diabetes mellitus 3. A diagnosis of diabetic peripheral neuropathy 4. Recently healed plantar ulcer (within the last 3 months)

Low risk group

Inclusion criteria: 1. Age \>18 2. A diagnosis of diabetes mellitus 3. Low risk for DFU according to the NG19 guidelines (no risk factors for ulceration except callus alone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

DFU group: Patients with a recently healed plantar ulcer recruited from a specialised Diabetes Limb Salvage Service in a tertiary referral centre. Low risk group: Patients with diabetes and low risk for ulceration recruited from the community podiatry service.

You may qualify if:

• Age \>18
• A diagnosis of diabetes mellitus
• A diagnosis of diabetic peripheral neuropathy
• Recently healed plantar ulcer (within the last 3 months)
• Able to provide informed consent
• Previous open or endovascular revascularisation
• Recently healed plantar DFU located on the right foot
• The right foot can be accommodated in a size 8-11 shoe
• Weight \<100kg
• Low risk group:
• Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria:
• Age \>18
• A diagnosis of diabetes mellitus
• Low risk for DFU according to the NICE NG 19 guidelines (no risk factors for ulceration except callus alone)
• Able to provide informed consent

You may not qualify if:

• Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessments
• Previous ipsilateral minor amputation
• Previous ipsilateral surgical offloading procedure
• Previous contralateral major amputation
• Ipsilateral toe pressure \<40mmHg
• The right foot can be accommodated in a size 8-11 shoe
• Weight \<100kg
• Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessments
• Previous ipsilateral minor amputation
• Presence of a foot deformity
• Previous contralateral major amputation
• Ipsilateral toe pressure \<40mmHg

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• David A Russell

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: January 18, 2023
• Study Start: July 1, 2022
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

GB (1)