Measuring plantar pressure during total contact softcast offloading versus conventional total contact cast offloading: a pilot study

Recruiting

• Conditions: diabetic foot ulcers. Foot ulceration. A wound on the foot in a person with diabetes mellitus; 10028393; 10047043; 10040795

• Registration Number: NL-OMON52242
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1) Age 18 years or older
2) Diagnosed with diabetes mellitus
3) A plantar diabetic foot ulcer on the forefoot or midfoot for which
offloading by total contact softcast or total contact cast is indicated

Exclusion Criteria

1) Inability or unwillingness to provide a written declaration of informed
consent.
2) Unable to mobilize weight-bearing
3) moderate or severe diabetic foot infection, as defined by the international
working group on the diabetic foot / infectous diseases society of America
(IWGDF / IDSA).
4) Moderate or severe limb ischemia, as defined in the Wound, Ischemia, foot
Infection (WIfI) classification.
5) The combination of mild limb ischemia and mild infection, defined in
accordance with the WIfI classification and IWGDF / IDSA definitions,
respectively.
6) Severe foot deformities (e.g. Charcot neuroarthropathy-related deformity,
ankle arthrodesis, partial calcanectomy) which lead to increased pressure and
friction on the site of the DFU and thereby make adequate TCSO or TCCO
impossible, as judged clinically by the treating physician

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Peak plantar pressure during a minimum of 12 midgait steps with the affected<br /><br>foot</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient comfort, expressed using a visual analoge scale. </p><br>